ISO 14971:2007
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical devices Application of risk management to medical devices
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
12-12-2019
Superseded by
Language(s)
English, French, Russian
Published date
28-02-2007
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
| DevelopmentNote |
Supersedes ISO 14971-1. (12/2000) DRAFT ISO/DIS 14971 is also available for this standard. (06/2018)
|
| DocumentType |
Standard
|
| Pages |
82
|
| ProductNote |
THIS STANDARD ALSO HAVE CORRECT VERSION FOR ENGLISH & FRENCH FOR THE YEAR 2007
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| CEI UNI EN ISO 14971 : 2013 | Identical |
| PN EN ISO 14971 : 2012 | Identical |
| NS EN ISO 14971 : 2012 | Identical |
| NEN EN ISO 14971 : 2007 + COR 2012 | Identical |
| BS EN ISO 14971:2012 | Identical |
| UNI CEI EN ISO 14971 : 2012 | Identical |
| NBN EN ISO 14971 : 2012 | Identical |
| GOST ISO 14971 : 2011 | Identical |
| SN EN ISO 14971 : 2012 | Identical |
| SS-EN ISO 14971 : 2012 | Identical |
| UNI EN ISO 14971 : 2008 | Identical |
| DIN EN ISO 14971:2013-04 | Identical |
| EN ISO 14971:2012 | Identical |
| I.S. EN ISO 14971:2012 | Identical |
| NF EN ISO 14971 : 2013 | Identical |
| UNE-EN ISO 14971:2009 | Identical |
| BS EN ISO 14971:2009 | Identical |
| GOST R ISO 14971 : 2009 | Identical |
| UNE-EN ISO 14971:2012 | Identical |
| CSA ISO 14971 : 2007 : R2012 | Identical |
| NF EN ISO 14971 : 2009-11 | Identical |
| AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 | Identical |
| AAMI ISO 14971 : 2007 : R2010 | Identical |
| BS EN ISO 14971:2007 | Identical |
| CSA ISO 14971 : 2007 | Identical |
| CSA ISO 14971 : 2007 : R2017 | Identical |
| UNE-EN ISO 14971:2007 | Identical |
| DIN EN ISO 10524-4:2008-09 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| 15/30321131 DC : 0 | BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
| DD CEN ISO/TS 22367:2010 | Medical laboratories. Reduction of error through risk management and continual improvement |
| ISO 20697:2018 | Sterile drainage catheters and accessory devices for single use |
| UNE-EN ISO 25539-2:2013 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| DIN EN ISO 18113-4:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| UNE-EN 80001-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ISO 19233-1:2017 | Implants for surgery — Orthopaedic joint prosthesis — Part 1: Procedure for producing parametric 3D bone models from CT data of the knee |
| BS EN 60601-1-2:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests |
| DIN EN ISO 11135-1:2007-08 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
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| CSA Z8835.3 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
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| 02/562586 DC : DRAFT JUN 2002 | BS EN 60601-1-8 - MEDICAL ELECTRICAL EQUIPMENT - PART 8-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ALARM SYSTEMS - REQUIREMENTS, TEST AND GUIDELINES - GENERAL REQUIREMENTS AND GUIDELINES FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND IN MEDICAL ELECTRICAL SYSTEMS |
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| AAMI SW87 : 2012 | APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS |
| CSA C22.2 No. 80601-2-35 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| I.S. EN ISO 5840:2009 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| CSA Z10524-3 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
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| 02/124462 DC : DRAFT DEC 2002 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| BS EN ISO 14155:2011 | Clinical investigation of medical devices for human subjects. Good clinical practice |
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| 04/30089749 DC : DRAFT DEC 2004 | BS EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
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| I.S. EN ISO 14155-2:2009 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
| ISO/TR 27809:2007 | Health informatics Measures for ensuring patient safety of health software |
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| CSA Z10524-1 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| I.S. EN 80001-1:2011 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES |
| BS EN ISO 5840-2:2015 | Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes |
| 14/30298693 DC : 0 | BS ISO 18250-8 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 8: CITRATE-BASED ANTICOAGULANT SOLUTION FOR APHERESIS APPLICATIONS |
| PD IEC/TR 62366-2:2016 | Medical devices Guidance on the application of usability engineering to medical devices |
| AAMI ISO 80369-1 : 2010 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 81060-1 : 2007 | NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
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| BS EN ISO 11073-20601:2016 | Health informatics. Personal health device communication Application profile. Optimized exchange protocol |
| AAMI ISO 80601-2-35 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| 09/30157835 DC : 0 | BS EN ISO/IEC 80001-1 - APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES |
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| ANSI/AAMI/ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
| BS ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
| DIN EN ISO 13017:2016-05 | DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015) |
| ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| BS EN ISO 80601-2-69:2014 | Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| UNE-EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
| BIS IS/ISO 10524-1 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| CSA Z8185 : 2008 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| CSA Z10535.1 : 2015 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| 04/300654 DC : DRAFT JAN 2004 | BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 15/30323081 DC : 0 | BS EN 80601-2-35 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| UNE-EN ISO 25539-3:2012 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| I.S. EN ISO 11073-10427:2018 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10427: DEVICE SPECIALIZATION - POWER STATUS MONITOR OF PERSONAL HEALTH DEVICES (ISO/IEEE 11073-10427:2018) |
| PD ISO/TS 17518:2015 | Medical laboratories. Reagents for staining biological material. Guidance for users |
| CSA ISO 26722 : 2016 | WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES |
| UNI EN ISO 18113-5 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF- TESTING |
| 09/30203808 DC : 0 | BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| DIN EN ISO 7197:2009-08 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| BS EN ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications Common test methods |
| 14/30295064 DC : 0 | BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES |
| 17/30303094 DC : 0 | BS EN ISO 10524-3 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| 16/30346073 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| DIN EN ISO 15223-1:2015-08 (Draft) | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
| UNE-EN 15908:2011 | Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
| DIN EN ISO 8835-3:2011-02 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| 17/30336573 DC : 0 | BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE |
| 13/30242951 DC : 0 | BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
| ISO/IEEE 11073-10424:2016 | Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) |
| 17/30336577 DC : 0 | BS EN ISO 20697 - STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE |
| 16/30310659 DC : 0 | BS EN ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES |
| 03/304741 DC : DRAFT APR 2003 | IEC 60601-1-6 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - USABILITY |
| 14/30287226 DC : 0 | BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| PREN 14180 : DRAFT 2012 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| DIN EN ISO 18113-3:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| DIN EN 1865-4:2012-09 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
| 12/30218032 DC : 0 | BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS |
| BS EN ISO 26782:2009 | Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans |
| BS EN ISO 15194:2009 | In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation |
| DIN EN ISO 26722:2016-02 | WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014) |
| ISO 8835-7:2011 | Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| I.S. EN 60601-1-10:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
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| 15/30278540 DC : 0 | BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
| DD ISO/TS 10993-19:2006 | Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials |
| ANSI/AAMI/ISO 20857:2010(R2015) | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN 61326-2-6:2013 | Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment |
| DIN EN ISO 11135:2014-10 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| 09/30191860 DC : 0 | BS EN 60601-1-6 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - USABILITY |
| DIN EN ISO 13408-7:2015-11 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012) |
| ANSI/AAMI/ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| CSA C22.2 No. 61010.1 : 2012 : INC : UPD 1 : 2015 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 23908:2013 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
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| 05/30129374 DC : 0 | ISO 15002 - FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| 05/30106190 DC : 0 | EN ISO 22442-1 - MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
| 06/30106186 DC : 0 | ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
| I.S. EN ISO 20857:2013 | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
| 03/311404 DC : 0 | IEC 61010-1 ED.3 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| UNE-EN ISO 18113-3:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| AAMI ISO 17665-1 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA ISO 11712 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS |
| IEC TR 62354:2014 | General testing procedures for medical electrical equipment |
| CSA Z10651.6 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
| BIS IS/ISO 10524-3 : 2005 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| I.S. EN ISO 10555-1:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| BS EN 62353:2014 | Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment |
| 04/30116660 DC : DRAFT JUL 2004 | IEC 61326-2-6 - ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN-VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| UNE-EN ISO 18113-2:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
| NF EN ISO 5361 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| CSA Z8185 : 2008(R2013) | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| BS EN ISO 10079-1:2015 | Medical suction equipment Electrically powered suction equipment |
| CSA Z11135-1 :2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN ISO 18113-3:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use |
| I.S. EN 14931:2006 | PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
| AAMI ISO TIR 16142 : 2005 | MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
| CSA Z11135 : 2015 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BIS IS/ISO 9170-1 : 2008 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM |
| 04/30088362 DC : DRAFT NOV 2004 | ISO 10651-5 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY VENTILATORS |
| I.S. EN ISO 18369-2:2017 | OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES (ISO 18369-2:2017) |
| ASTM F 2726 : 2008 | Standard specification for fixation devices for tracheal tubes and other airway devices |
| CSA Z10083 : 2008 | OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS |
| 08/30133979 DC : DRAFT MAY 2008 | BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS |
| ISO 13019:2018 | Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| CSA ISO 14937 : 2011 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI ISO 13408-1 : 2008 : R2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| ISO 23409:2011 | Male condoms Requirements and test methods for condoms made from synthetic materials |
| CAN/CSA-ISO 17664:18 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices (Adopted ISO 17664:2017, second edition, 2017-10) |
| BIS IS/ISO 15197 : 2013 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| I.S. EN ISO 14607:2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018) |
| CSA ISO/IEC 16085 : 2007 | SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT |
| ISO 11197:2016 | Medical supply units |
| CSA Z11135-1 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ANSI/AAMI/ISO 14937:2009(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CAN/CSA-Z316.6:2014(R2019) | Sharps injury protection - Requirements and test methods - Sharps containers (Adopted ISO 23907:2012, first edition, 2012-09-01, with Canadian deviations) |
| UNE-EN ISO 80601-2-69:2015 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| ONORM EN ISO 5840-3 : 2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| DIN EN ISO 7199:2015-06 (Draft) | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
| ISO 19227:2018 | Implants for surgery — Cleanliness of orthopedic implants — General requirements |
| CSA C22.2 No. 61010.2.040 : 2016 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS |
| CSA Z17665-1 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 15/30321242 DC : 0 | BS EN ISO 12870 - OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS |
| ANSI/AAMI/ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| BS ISO 13779-6:2015 | Implants for surgery. Hydroxyapatite Powders |
| I.S. EN ISO 12870:2014 | OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2016) |
| I.S. EN 62570:2015 | STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
| I.S. EN ISO 81060-1:2012 | NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007) |
| AAMI/ISO TIR17665-3:2014(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| I.S. EN ISO 11073-10419:2016 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION PART 10419: DEVICE SPECIALIZATION - INSULIN PUMP (ISO/IEEE 11073-10419:2016) |
| I.S. EN ISO 11073-10424:2016 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10424: DEVICE SPECIALIZATION - SLEEP APNOEA BREATHING THERAPY EQUIPMENT (SABTE) (ISO/IEEE 11073-10424:2016) |
| PREN ISO 11137-2 : DRAFT 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| BS EN ISO 11073-10424:2016 | Health informatics. Personal health device communication Device specialization. Sleep apnoea breathing therapy equipment (SABTE) |
| I.S. EN ISO 26782:2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| BS EN ISO 7396-1:2016 | Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| GOST ISO 14698-1 : 2005 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| CEI EN 61326-2-6 : 2014 | ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| IEC TR 62348:2012 | Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition |
| BS EN ISO 17664:2017 | Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices |
| I.S. EN ISO 5840-1:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| I.S. EN ISO 10524-4:2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS |
| ANSI/AAMI/ISO 15674:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| ANSI/AAMI/ISO 11135:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ANSI/AAMI/ISO 80369-20:2015 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS |
| DIN EN ISO 14607:2009-08 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
| BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
| I.S. EN 15546-1:2008 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 10993-17 : 2002 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES |
| ISO 7176-16:2012 | Wheelchairs Part 16: Resistance to ignition of postural support devices |
| BS EN 60601-1-6 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| AAMI IEC 62366-1 : 2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| AAMI/IEC TIR80001-2-3:2012 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS |
| ISO 11658:2012 | Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| ISO 13179-1:2014 | Implants for surgery Plasma-sprayed unalloyed titanium coatings on metallic surgical implants Part 1: General requirements |
| UNI EN ISO 13408-6 : 2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| CSA ISO TR 13154 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH |
| UNI EN ISO 18113-4 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| UNI CEI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| CSA Z17665-1 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN ISO 10079-1:2015 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
| AAMI TIR38 : 2015 | MEDICAL DEVICE SAFETY ASSURANCE CASE REPORT GUIDANCE |
| UNE-EN ISO 22442-1:2016 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| AAMI CN6 : 2015 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS |
| AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| I.S. EN 60601-1-2:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| BS EN ISO 11073-10427:2018 | Health informatics. Personal health device communication Device specialization. Power status monitor of personal health devices devices |
| AAMI ISO TIR 10974 : 2012 | ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE |
| I.S. EN ISO 10993-16:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2010) |
| BIS IS/ISO 11979-8 : 2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| ONORM EN ISO 10524-1 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| UNI EN 12183 : 2014 | MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
| I.S. EN 80601-2-35:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| UNE-EN ISO 15621:2018 | Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017) |
| UNE-EN ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15) |
| ISO 14607:2007 | Non-active surgical implants Mammary implants Particular requirements |
| NF EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| ISO 10083:2006 | Oxygen concentrator supply systems for use with medical gas pipeline systems |
| UNE-EN ISO 18113-5:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| UNI CEI EN 980 : 2009 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| ASTM F 2212 : 2011 : REDLINE | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ONORM EN ISO 10993-12 : 2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) |
| ASTM E 2898 : 2014 : REDLINE | Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications |
| I.S. EN 1865-2:2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| ASTM F 3089 : 2014 | Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| I.S. EN ISO 15194:2009 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
| CSA C22.2 No. 61010.1 : 2012 : INC : UPD 1 :2015 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| ISO 10524-3:2005 | Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves |
| ISO 16037:2002 | Rubber condoms for clinical trials Measurement of physical properties |
| ISO 80601-2-55:2018 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| ISO/TR 21730:2007 | Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices |
| AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN ISO 11979-5:2010-11 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
| BS EN ISO 80601-2-13:2012+A2:2019 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| DIN EN ISO 22442-1:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| DIN EN ISO 21969:2010-04 | High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| DIN EN 1422:2014-08 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| DIN EN 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
| DIN EN ISO 11137-3:2015-08 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
| UNE-EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| BS EN 13718-1:2014 | Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
| ISO 10524-4:2008 | Pressure regulators for use with medical gases — Part 4: Low-pressure regulators |
| BS EN ISO 10993-1 : 2009-10 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
| BS EN 556-1:2001 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices |
| BS EN ISO 10993-12:2012 | Biological evaluation of medical devices Sample preparation and reference materials |
| BS EN ISO 11979-9 : 2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES |
| ISO 23907:2012 | Sharps injury protection Requirements and test methods Sharps containers |
| ISO 81060-1:2007 | Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type |
| I.S. EN ISO 13485:2016 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016) |
| ISO 7494-2:2015 | Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems |
| UNE-EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| ISO 13958:2014 | Concentrates for haemodialysis and related therapies |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| BS EN ISO 22803:2005 | Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN 455-3:2015 | Medical gloves for single use Requirements and testing for biological evaluation |
| BS EN ISO 22523:2006 | External limb prostheses and external orthoses. Requirements and test methods |
| BS EN ISO 15001:2011 | Anaesthetic and respiratory equipment. Compatibility with oxygen |
| BS EN ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling |
| BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
| ISO 25539-3:2011 | Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
| ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
| UNE-EN ISO 16672:2016 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| BS EN ISO 14630:2012 | Non-active surgical implants. General requirements |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| BS EN ISO 16201:2006 | Technical aids for disabled persons. Environmental control systems for daily living |
| ISO 23640:2011 | In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents |
| I.S. EN ISO 11608-1:2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
| I.S. EN ISO 10535:2006 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 10524-2:2006-07 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| UNI EN ISO 9170-1 : 2008 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM |
| DIN EN 14931:2006-08 | Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
| DIN EN ISO 14155-2:2003-09 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
| EN ISO 11979-8:2017 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
| EN ISO 25539-3:2011 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| OVE/ONORM EN 60601-1-10 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
| DIN EN ISO 14155-1:2003-09 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
| EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN ISO 80601-2-13:2012 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| DIN EN ISO 14155-1:2009-11 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| DIN EN 15908:2011-01 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| EN ISO 9680:2014 | Dentistry - Operating lights (ISO 9680:2014) |
| EN ISO 22523:2006 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| CEN/TS 15260:2006 | Health informatics - Classification of safety risks from health informatics products |
| DIN EN ISO 14698-1:2004-04 | Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003) |
| EN ISO 21647:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005) |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| EN 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| NF EN ISO 10993-18 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| UNI EN ISO 10993-12 : 2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| I.S. EN ISO 16201:2006 | TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING |
| ONORM EN ISO 7494-2 : 2015 | DENTISTRY - DENTAL UNITS - PART 2: AIR, WATER, SUCTION AND WASTEWATER SYSTEMS (ISO 7494-2:2015) |
| VDI 5703:2015-09 | Systematical development for a model-based testing of medical devices |
| CLSI M52:2010(R2020) | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems |
| ONORM EN 12184 : 2014 | ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| ONORM EN 12183 : 2015 | MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
| VDI 5700 Blatt 1:2015-04 | Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
| ONORM EN ISO 7439 : 2015 | COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015) |
| ONORM EN ISO 11608-5 : 2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
| ONORM EN ISO 11608-1 : 2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
| BS ISO 19611:2017 | Traditional Chinese medicine. Air extraction cupping device |
| ANSI/AAMI/ ISO 11137-2:2013(R2019) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| BS EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| ONORM EN ISO 11979-5 : 2010 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
| 12/30159217 DC : 0 | BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| CAN/CSA-ISO 16571:16 | SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
| ONORM EN ISO 10993-1 : 2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| CSA Z10524-2 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| ISO/TR 20520:2018 | Traditional Chinese medicine Infection control for acupuncture treatment |
| 16/30314880 DC : 0 | BS EN ISO 9170-1 - TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM |
| UNI EN ISO 26782 : 2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
| BS EN ISO 80601-2-13:2012 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| AAMI ISO 20857 : 2010 | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 09/30173644 DC : 0 | BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| BS EN ISO 20857:2013 | Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices |
| I.S. EN 1041:2008+A1:2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| BS EN ISO 80601-2-72:2015 | Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| 17/30359001 DC : 0 | BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
| BS EN ISO 26722:2015 | Water treatment equipment for haemodialysis applications and related therapies |
| BS ISO 15001 : 2003 AMD 15145 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN |
| 15/30328959 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| I.S. EN 82304-1:2017 | HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| PD IEC/TR 60601-4-1:2017 | Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| ISO/IEEE 11073-10425:2016 | Health informatics Personal health device communication Part 10425: Device specialization Continuous glucose monitor (CGM) |
| UNE-EN ISO 11608-5:2013 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| 12/30262894 DC : 0 | BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| NF EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| ISO 16971:2015 | Ophthalmic instruments — Optical coherence tomograph for the posterior segment of the human eye |
| BS EN ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| I.S. EN ISO 17665-1:2006 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 08/30154605 DC : DRAFT APR 2008 | BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
| BS ISO 8600-1:2015 | Endoscopes. Medical endoscopes and endotherapy devices General requirements |
| NF EN ISO 80369-7 : 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| UNE-EN ISO 13504:2013 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012) |
| ANSI/AAMI/IEC 60601-1-2:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| DIN EN ISO 11608-5:2013-01 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| I.S. EN 1865-3:2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| 16/30302523 DC : 0 | BS EN ISO 15621 - ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| I.S. EN 61010-2-040:2015 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS |
| UNI EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| ANSI/AAMI/ISO 15675:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| PD ISO/TS 17822-1:2014 | <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions |
| DIN EN 15546-1:2008-08 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 26782:2010-02 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009) |
| BS EN ISO 23907:2012 | Sharps injury protection. Requirements and test methods. Sharps containers |
| 08/30179586 DC : DRAFT MAR 2008 | BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| BS ISO 10651-5:2006 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators |
| AAMI ISO 5361 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| BS EN ISO 11979-7:2014 | Ophthalmic implants. Intraocular lenses Clinical investigations |
| PD IEC/TR 80001-2-9:2017 | Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
| BS ISO/IEEE 11073-10441 : 2015 COR 2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10441: DEVICE SPECIALIZATION - CARDIOVASCULAR FITNESS AND ACTIVITY MONITOR |
| DIN ISO 13022 E : 2014 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
| DIN EN ISO 80601-2-72:2016-04 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| AAMI IEC TIR 80001-2-2 : 2012 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS |
| 10/30216029 DC : 0 | BS EN 61326-2-6 - ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| BS ISO 16840-6:2015 | Wheelchair seating Simulated use and determination of the changes in properties of seat cushions |
| I.S. EN ISO 23907:2012 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS CONTAINERS (ISO 23907:2012) |
| BS EN ISO 10524-1:2006 | Pressure regulators for use with medical gases Pressure regulators and pressure regulators with flow-metering devices |
| 12/30269739 DC : 0 | IEC 61010-2-101 ED 2 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR LABORATORY EQUIPMENT FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| AAMI TIR52 : 2014(R2017) | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| UNE-EN ISO 80369-1:2011 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| DD ISO/TS 25238:2007 | Health informatics. Classification of safety risks from health software |
| EN ISO 80369-6 : 2016 COR 2016 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO 80369-6:2016, CORRECTED VERSION 2016-11-15) |
| I.S. EN ISO 13940:2016 | HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE (ISO 13940:2015) |
| 06/30146526 DC : 0 | BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| DIN EN ISO 15621:2016-06 (Draft) | ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION (ISO 15621:2017) |
| ISO 12870:2016 | Ophthalmic optics Spectacle frames Requirements and test methods |
| 13/30240399 DC : 0 | ISO/IEC GUIDE 51 - SAFETY ASPECTS - GUIDELINES FOR THEIR INCLUSION IN STANDARDS |
| 06/30146522 DC : 0 | BS ISO 18113-4 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| DIN EN ISO 13408-6:2013-07 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013) |
| BS ISO 15378 : 2006 AMD 17315 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| PD ISO/TR 13014:2012 | Nanotechnologies. Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment |
| BS EN ISO 13408-7:2015 | Aseptic processing of health care products Alternative processes for medical devices and combination products |
| 15/30321715 DC : 0 | BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| 13/30268585 DC : 0 | BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| PD ISO/TS 17665-3:2013 | Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| 04/30057165 DC : 0 | BS EN 14931 - PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBERS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
| I.S. EN ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| 14/30295067 DC : 0 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| 17/30344601 DC : 0 | BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 14/30281560 DC : 0 | BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| UNE-EN ISO 18113-4:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| 08/30179589 DC : DRAFT MAR 2008 | BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| BS ISO 11658:2012 | Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| 02/564924 DC : DRAFT NOV 2002 | ISO 21647 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| DIN EN ISO 23907:2013-01 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS CONTAINERS (ISO 23907:2012) |
| DIN EN ISO 10524-1:2006-05 | PRESSURE REGULATORS FOR USE WITH MEDICAL GAS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| BS EN ISO 7199:2017 | Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) |
| BS ISO 13179-1:2014 | Implants for surgery. Plasma-sprayed unalloyed titanium coatings on metallic surgical implants General requirements |
| 06/30145887 DC : DRAFT FEB 2006 | EN ISO 10993-12 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| DIN EN ISO 15002:2008-11 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| 13/30281504 DC : 0 | BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| 11/30193150 DC : 0 | BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| 15/30321712 DC : 0 | BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| 14/30267655 DC : 0 | BS ISO 13779-6 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 6: POWDERS |
| 11/30212235 DC : 0 | BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
| BS EN ISO 13940:2016 | Health informatics. System of concepts to support continuity of care |
| 15/30321957 DC : 0 | BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| UNI EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| PD ISO/TR 21730:2007 | Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices |
| DIN EN ISO 25539-3:2012-03 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| 15/30280904 DC : 0 | BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
| 06/30146515 DC : 0 | BS ISO 18113-2 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| EN 82304-1:2017 | Health Software - Part 1: General requirements for product safety |
| ANSI Z80.11:2012 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| 17/30323851 DC : 0 | BS ISO 19894 - WALKING TROLLEYS - REQUIREMENTS AND TEST METHODS |
| CAN/CSA-Z15002:12 (R2017) | Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations) |
| 12/30212355 DC : 0 | BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA SPRAYED COATINGS OF UNALLOYED TITANIUM - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 13958:2016-03 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
| AAMI ISO 10993-16 : 2010 : R2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| BS EN ISO 18113-4:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing |
| 04/30066665 DC : DRAFT MARCH 2004 | BS ISO 13408-6 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6 - ISOLATOR SYSTEMS |
| PD ISO/TR 13154:2017 | Medical electrical equipment. Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph |
| 10/30195946 DC : DRAFT DEC 2010 | BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
| 13/30276231 DC : 0 | BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| 14/30294895 DC : 0 | BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN |
| 09/30195717 DC : 0 | BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS |
| BS EN 45502-2-3:2010 | Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems |
| 04/30048205 DC : DRAFT JUL 2004 | BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 13/30270468 DC : 0 | BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 03/103026 DC : DRAFT JAN 2003 | BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| 14/30266295 DC : 0 | BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS |
| CSA Z1500:2012 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| TR 102 415 : 1.1.1 | HUMAN FACTORS (HF); TELECARE SERVICES; ISSUES AND RECOMMENDATIONS FOR USER ASPECTS |
| AAMI ISO 5840 : 2005 : R2010 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| CEI EN 80369-5 : 1ED 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
| BS ISO 15674:2009 | Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| CSA Z11137-2 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| BS ISO/IEC 16085:2006 | Systems and software engineering. Life cycle processes. Risk management |
| DIN EN ISO 11979-7:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014) |
| 08/30179592 DC : DRAFT MAR 2008 | BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| BS ISO 81060-1 : 2007 COR 2012 | NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
| BS EN 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| DIN EN ISO 14155:2012-01 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
| 16/30302520 DC : 0 | BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE |
| BS EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications |
| AAMI ISO 5840 :2005 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| PD ISO/TR 16142:2006 | Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| S.R. CEN/CLC/TR 14060:2014 | MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI) |
| 17/30311331 DC : 0 | BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| CSA ISO/IEC 16085 : 2007 : R2012 | SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT |
| I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| CSA Z8836 :2011 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| DIN EN ISO 18113-2:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
| CSA Z8836 : 2011 : R2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| ANSI/AAMI/ISO 15223-1:2016 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| CSA Z21647 : 2007 : R2012 : FR | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| UNI CEN ISO/TS 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| AAMI/ISO TIR15499:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS |
| UNE-EN ISO 15378:2016 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) |
| BS EN ISO 10555-1 : 2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 5361:2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014) |
| I.S. EN 61010-2-101:2017 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| I.S. EN 62366-1:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| UNI EN ISO 5840-3 : 2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| BS EN 61810-1:2015 | Electromechanical elementary relays General and safety requirements |
| S.R. CWA 16697:2013 | CAR-ADAPTATIONS FOR DISABLED DRIVERS - REQUIREMENTS, TEST METHODS AND BEST PRACTISE GUIDELINES |
| ISO/TR 80002-2:2017 | Medical device software — Part 2: Validation of software for medical device quality systems |
| ISO/TS 19930:2017 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| ISO 11712:2009 | Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors |
| UNE-EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| UNE-EN ISO 13408-6:2011 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) |
| I.S. EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
| BS EN ISO 13408-1:2015 | Aseptic processing of health care products General requirements |
| UNE-EN ISO 14155:2012 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) |
| AAMI ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| AAMI ISO 11137-2 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| BS EN 60601-1-8 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006) |
| CSA ISO 10079-3:14 (R2019) | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01) |
| I.S. EN 62353:2014 | MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
| EN 60601-1-10:2008/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007) |
| AAMI/ISO TIR 80002-2:2017 | MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS |
| AAMI BE83 : 2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| BS EN ISO 13017 : 2012 | DENTISTRY - MAGNETIC ATTACHMENTS |
| AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
| BS EN ISO 13408-6 : 2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| UNI EN ISO 80601-2-55 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| AAMI ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| I.S. EN ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO/IEC/DIS 80369-3:2014) |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
| AAMI TIR45 : 2012 | GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process |
| CEI UNI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| ISO 18362:2016 | Manufacture of cell-based health care products Control of microbial risks during processing |
| CEI UNI EN 1041 : 2014 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| CSA Z17665-2:09 (R2019) | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
| ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate |
| CSA IEC 62366-1 : 2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| AAMI ISO 14155 : 2011 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE |
| CSA ISO 11712:14 (R2019) | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15) |
| BS EN ISO 5359 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
| BS EN ISO 14607:2009 | Non-active surgical implants. Mammary implants. Particular requirements |
| UNI EN ISO 14155 : 2012 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE |
| CSA C22.2 No. 80601-2-69 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| UNI EN ISO 14607 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
| CSA ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
| BS ISO 7176-16:2012 | Wheelchairs Resistance to ignition of postural support devices |
| CEI UNI EN/ISO 80369-7 : 1ED 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS |
| CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| BS EN ISO 5367:2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
| DIN EN 12183:2014-06 | Manual wheelchairs - Requirements and test methods |
| UNE-EN ISO 5367:2015 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| ONORM EN ISO 10524-2 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| I.S. EN ISO 13408-6:2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005) |
| ISO 11040-8:2016 | Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| AAMI ISO 15223-2 : 2010 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
| ISO 16840-6:2015 | Wheelchair seating — Part 6: Simulated use and determination of the changes in properties of seat cushions |
| CSA C22.2 No. 80601-2-12 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| BS EN ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications |
| CSA C22.2 No. 60601-1-10 : 2009 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| ISO 18666:2015 | Traditional Chinese medicine General requirements of moxibustion devices |
| CSA C22.2 No. 80601-2-35 : 2012 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| EN ISO 11979-10:2018 | Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018) |
| ISO 15194:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation |
| UNE-EN ISO 13958:2016 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
| NF EN 62366-1 : 2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| I.S. EN 556-1:2002 | STERILISATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED STERILE - PART 1: REQUIREMENTS FOR TERMINALLY STERILISED MEDICAL DEVICES |
| UNI EN ISO 12870 : 2015 | OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS |
| AAMI/IEC TIR80001-2-5:2014 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS |
| ANSI/AAMI/IEC TIR62354:2015 | GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT |
| IEC TR 61258:2008 | Guidelines for the development and use of medical electrical equipment educational materials |
| ISO 9170-1:2017 | Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| IEC TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |
| DIN EN ISO 22442-2:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| AAMI ES60601-1 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| EN 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| DIN EN 1639:2010-02 | Dentistry - Medical devices for dentistry - Instruments |
| DIN EN 1641:2010-02 | Dentistry - Medical devices for dentistry - Materials |
| DIN EN 556-2:2015-11 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| DIN EN ISO 23747:2015-12 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015) |
| DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
| DIN EN ISO 17665-1:2006-11 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| DIN EN ISO 17510-2:2009-07 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| DIN EN ISO 22803:2006-01 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| DIN EN 1640:2010-02 | Dentistry - Medical devices for dentistry - Equipment |
| DIN EN 12184:2014-06 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| DIN EN ISO 7494-2:2015-08 | Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
| DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| DIN EN ISO 4074:2016-05 | NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
| DIN EN ISO 11979-9:2014-12 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014) |
| DIN EN ISO 10993-18:2009-08 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009 |
| DIN EN ISO 16672:2015-12 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| DIN EN ISO 10993-12:2012-10 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| BS EN ISO 7864:2016 | Sterile hypodermic needles for single use. Requirements and test methods |
| BS EN ISO 10535:2006 | Hoists for the transfer of disabled persons. Requirements and test methods |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| BS EN 556-2:2015 | Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' Requirements for aseptically processed medical devices |
| UNE-EN ISO 21969:2010 | High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| UNE-EN 14065:2017 | Textiles - Laundry processed textiles - Biocontamination control system |
| UNE-EN ISO 80601-2-13:2013 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
| BS EN ISO 7494-2:2015 | Dentistry. Dental units Air, water, suction and wastewater systems |
| BS EN 1640:2009 | Dentistry. Medical devices for dentistry. Equipment |
| BS EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices. Requirements and tests |
| BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
| BS EN ISO 10079-2:2014 | Medical suction equipment Manually powered suction equipment |
| IEC 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| BS EN 1639:2009 | Dentistry. Medical devices for dentistry. Instruments |
| BS EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Application of risk management |
| UNE-EN ISO 23747:2016 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015) |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO/IEEE 11073-10441:2015 | Health informatics — Personal health device communication — Part 10441: Device specialization — Cardiovascular fitness and activity monitor |
| ISO 11608-7:2016 | Needle-based injection systems for medical use Requirements and test methods Part 7: Accessibility for persons with visual impairment |
| ISO 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| BS EN ISO 14698-1:2003 | Cleanrooms and associated controlled environments. Biocontamination control General principles and methods |
| DIN EN ISO 9680:2015-02 | Dentistry - Operating lights (ISO 9680:2014) |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ONORM EN 13718-1 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| EN ISO 25539-2:2012 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| I.S. EN ISO 15197:2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
| I.S. EN ISO 14534:2015 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
| I.S. EN 12184:2014 | ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| EN ISO 5840-2:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| I.S. EN ISO 22794:2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| I.S. EN ISO 23747:2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015) |
| I.S. EN 14065:2016 | TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| I.S. EN ISO 14937:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| I.S. EN ISO 10079-2:2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
| I.S. EN ISO 9626:2016 | STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 17510-2:2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| UNI EN ISO 10993-18 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| I.S. EN 12182:2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 7439:2015 | COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015) |
| I.S. EN ISO 11137-2:2015 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013) |
| I.S. EN ISO 15001:2011 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN (ISO 15001:2010) |
| I.S. EN ISO 8537:2016 | STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016) |
| I.S. EN ISO 22442-2:2015 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015) |
| I.S. EN ISO 22442-1:2015 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
| I.S. EN 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| I.S. EN 1639:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| I.S. EN ISO 9680:2014 | DENTISTRY - OPERATING LIGHTS (ISO 9680:2014) |
| I.S. EN 1640:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| I.S. EN ISO 11137-3:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
| I.S. EN ISO 10993-17:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002) |
| EN ISO 5840-1:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| I.S. EN ISO 4074:2015 | NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
| ONORM EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| I.S. EN ISO 8185:2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| DIN EN ISO 11137-2:2015-11 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| UNI EN 13718-1 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| I.S. EN ISO 7494-2:2015 | DENTISTRY - DENTAL UNITS - PART 2: AIR, WATER, SUCTION AND WASTEWATER SYSTEMS (ISO 7494-2:2015) |
| EN ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
| I.S. EN 1422:2014 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| I.S. EN 1641:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| DIN EN 14180:2003-10 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| I.S. EN ISO 10651-6:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| I.S. EN ISO 11979-8:2017 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| I.S. EN ISO 10451:2010 | DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| I.S. EN ISO 10993-12:2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) |
| I.S. EN 14180:2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| DIN EN ISO 10651-2:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| I.S. EN ISO 14630:2012 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| DIN EN 1789:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| I.S. EN ISO 21969:2009 | HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS |
| I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 7864:2016 | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014) |
| I.S. EN ISO 11979-6:2014 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014) |
| I.S. EN ISO 14698-1:2003 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS |
| I.S. EN ISO 10993-13:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010) |
| I.S. EN ISO 16672:2015 | OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
| I.S. EN ISO 10079-3:2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
| DIN EN 1422:1997-11 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| DIN 820-12:2014-06 | STANDARDIZATION - PART 12: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:2014) |
| UNI EN ISO 11979-6 : 2015 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING |
| UNI EN 1642 : 2012 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| BIS IS/ISO 14708-3 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| VDI 5702 Blatt 1:2017-04 | Medical device software - Medical SPICE Process assessment model |
| VDI 4007:2012-06 | Reliability goals - Determination, check, review, certificate |
| VDI 4003:2007-03 | Reliability management |
| NEMA/MITA XR 30:2016 | Quality Control Tools for Digital Projection Radiography |
| NEMA/MITA 1:2015 | Good Refurbishment Practices for Medical Imaging Equipment |
| OVE/ONORM EN 60601-1 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| UNE-EN ISO 5840-2:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| UNI EN ISO 9170-2 : 2008 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS |
| BS ISO 15198:2004 | Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer |
| I.S. EN 12183:2014 | MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
| CSA Z10524-1 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| UNI EN ISO 81060-1 : 2012 | NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
| 16/30339831 DC : 0 | PD ISO/TR 14283 - IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE |
| BS ISO 17218:2014 | Sterile acupuncture needles for single use |
| CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| 13/30260084 DC : 0 | BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS |
| 15/30281262 DC : 0 | BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES |
| PD ISO/TR 19244:2014 | Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters |
| I.S. EN 285:2015 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| 09/30197590 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 10/30196945 DC : 0 | BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| ANSI/AAMI/IEC 80001-1:2010 | APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES |
| 13/30285624 DC : 0 | BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 07/30151731 DC : 0 | BS IEC 80601-2-35 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE |
| 08/30116059 DC : DRAFT AUG 2008 | ISO 14155 REV - CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS |
| 16/30312315 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| 14/30270462 DC : 0 | BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| ISO 14708-7:2013 | Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems |
| DIN EN 1865-2:2015-05 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher (includes Amendment A1:2015) |
| PD ISO/TR 16197:2014 | Nanotechnologies. Compilation and description of toxicological screening methods for manufactured nanomaterials |
| ISO 29942:2011 | Prophylactic dams — Requirements and test methods |
| BS ISO 15223-2:2010 | Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation |
| ANSI/AAMI/IEC TIR62348:2012 | ASSESSMENT OF THE IMPACT OF THE MOST SIGNIFICANT CHANGES IN AMENDMENT 1 TO IEC 60601-1:2005 AND MAPPING OF THE CLAUSES OF IEC 60601-1:2005 TO THE PREVIOUS EDITION |
| 15/30300279 DC : 0 | BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| BS ISO 15675:2009 | Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters |
| AAMI TIR36 : 2007 | VALIDATION OF SOFTWARE FOR REGULATED PROCESSES |
| 16/30346829 DC : 0 | BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS |
| BS EN 80001-1:2011 | Application of risk management for IT-networks incorporating medical devices Roles, responsibilities and activities |
| BS ISO 25841:2017 | Female condoms. Requirements and test methods |
| 17/30321196 DC : 0 | BS EN ISO 23500-2 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 2: WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| I.S. CEN ISO TR 14969:2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
| 17/30321202 DC : DRAFT MAY 2017 | BS EN ISO 23500-4 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 4: CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| BS EN ISO 7197:2009 | Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
| BS EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications Connectors for intravascular or hypodermic applications |
| 11/30243761 DC : 0 | BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
| UNE-EN 1865-1:2011 | Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
| BS EN 82304-1:2017 | Health Software General requirements for product safety |
| I.S. EN 61326-2-6:2013 | ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV)) |
| AAMI ISO 10651-5 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| DIN EN ISO 18113-5:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| UNI EN ISO 11073-30400 : 2013 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET |
| ISO 20696:2018 | Sterile urethral catheters for single use |
| BS EN ISO 81060-1:2012 | Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type |
| 17/30343686 DC : 0 | BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| 13/30270477 DC : 0 | BS ISO 26722 - WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES |
| BS EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements |
| ISO/TS 17518:2015 | Medical laboratories — Reagents for staining biological material — Guidance for users |
| UNI EN ISO 80601-2-69 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| ISO 16571:2014 | Systems for evacuation of plume generated by medical devices |
| BS EN 15908:2010 | Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
| 13/30255929 DC : 0 | BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| AAMI ISO 10993-1:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| BS PD ISO/TR 14969 : 2004 AMD 15958 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| 12/30251858 DC : 0 | BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS |
| PD ISO/TR 22979:2017 | Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| BS ISO 16038:2017 | Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 13/30278676 DC : 0 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| UNE-EN ISO 11135:2015 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| BS ISO 23409:2011 | Male condoms. Requirements and test methods for condoms made from synthetic materials |
| DD CEN/TS 14507-2:2003 | Inhalational nitric oxide systems Supply systems |
| UNE-EN 62353:2015 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| 13/30280551 DC : 0 | BS ISO 16840-6 - WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES - SEAT CUSHIONS |
| 09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
| BS EN ISO 11608-5:2012 | Needle-based injection systems for medical use. Requirements and test methods Automated functions |
| I.S. EN ISO 10524-3:2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005) |
| BS ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements |
| BS ISO 18562-2:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for emissions of particulate matter |
| 14/30296035 DC : 0 | BS ISO 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS |
| 09/30176675 DC : 0 | BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| BS EN 15546-1:2008 | Small bore connectors for liquids and gases in healthcare applications General requirements |
| PD ISO/TR 80002-2:2017 | Medical device software Validation of software for medical device quality systems |
| AAMI ISO TIR 14969 : 2004 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| NF EN ISO 25539-2 : 2013 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
| 10/30208977 DC : 0 | BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
| AAMI ISO 81060-1:2007(R2013) | NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
| ANSI/AAMI/ISO TIR10993-19:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
| BS EN ISO 9170-2:2008 | Terminal units for medical gas pipeline systems Terminal units for anaesthetic gas scavenging systems |
| BS EN ISO 5840-1:2015 | Cardiovascular implants. Cardiac valve prostheses General requirements |
| BS EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| I.S. EN ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
| 17/30336158 DC : 0 | BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA |
| BS EN ISO 15621:2017 | Absorbent incontinence aids for urine and/or faeces. General guidelines on evaluation |
| AAMI IEC 62366 : 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| 04/30099768 DC : DRAFT DEC 2004 | PREN ISO 8835-3 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: ANAESTHETIC GAS SCAVENGING SYSTEMS - TRANSFER AND RECEIVING SYSTEMS |
| CSA Z8836 : 2011 : FR | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| CSA IEC 62366 : 2014 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| EN ISO 11135:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| UNI EN ISO 20072 : 2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| UNE-EN ISO 10079-1:2016 | Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) |
| UNI EN ISO 8836 : 2015 | A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| BS EN 60601-1-10 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| BIS IS/ISO 10524-2 : 2005 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| BS ISO 25539-1 : 2003 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 14/30257644 DC : 0 | BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
| CSA C22.2 No. 61010.1 :2012 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| UNE-EN ISO 8836:2015 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| BS EN ISO 5840-3:2013 | Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
| UNE-EN 60601-1-6:2010 | Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| CSA Z10651.6 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| I.S. CEN TS 15260:2006 | HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS |
| UNE-EN 80369-5:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
| AAMI/IEC TIR80002-3:2016 | MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) |
| CSA Z11135-1 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNE-EN ISO 5840-1:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| CSA ISO 14937 : 2011 : R2016 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO/TS 20993:2006 | Biological evaluation of medical devices Guidance on a risk-management process |
| AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| CSA Z11137-2 : 2007 : R2012 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| ANSI/AAMI/ISO 22442-1:2016 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
| CSA ISO/IEC 16085 : 2007 : R2017 | SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT |
| CSA Z17665-1:09 (R2019) | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations) |
| DIN EN ISO 5840-2:2016-05 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| DIN ISO 13022:2014-06 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
| ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements |
| UNI EN ISO 11608-5 : 2013 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
| I.S. EN 80369-5:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| DIN EN ISO 5840-1:2015-12 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| IEC TS 62844:2016 | Guidelines for quality and risk assessment for nano-enabled electrotechnical products |
| IEC TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| BS EN 1865-2 : 2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| PREN ISO 80369-1 : DRAFT 2009 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN 60601-1-8:2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| AAMI ISO 25539-3 : 2011 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| CAN/CSA-ISO 11137-3:17 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control (Adopted ISO 11137-3:2017, second edition, 2017-06) |
| I.S. EN ISO 20608:2018 | DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018) |
| I.S. EN ISO 15621:2017 | ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION (ISO 15621:2017) |
| BS ISO/IEC 15026-3:2015 | Systems and software engineering. Systems and software assurance System integrity levels |
| I.S. EN ISO 10524-1:2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| I.S. EN ISO 5840-2:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
| I.S. EN ISO 11073-10441:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10441: DEVICE SPECIALIZATION - CARDIOVASCULAR FITNESS AND ACTIVITY MONITOR (ISO/IEEE 11073-10441:2015) |
| I.S. EN ISO 13408-7:2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012) |
| EN 80601-2-35:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016) |
| BS EN ISO 18369-2:2017 | Ophthalmic optics. Contact lenses Tolerances |
| ANSI/AAMI/ISO 11658:2012 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
| AAMI ISO 14937:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ANSI/AAMI/ISO TIR10993-20:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES |
| ANSI/AAMI ISO 17665-1:2006(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN ISO 15223-1:2016 | Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements |
| EN 13060:2014 | Small steam sterilizers |
| AAMI TIR48 : 2015 | QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS |
| ANSI/AAMI/ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| AAMI ISO 5840-1 : 2016 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| ANSI/AAMI/ISO 80369-7:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 12183:2009 | Manual wheelchairs - Requirements and test methods |
| AAMI ISO 14708-5 : 2010 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| CSA C22.2 No. 80601-2-35 : 2012(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| BS EN 62366 : 2008 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| UNI EN ISO 5361 : 2013 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| EN ISO 15378:2017 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017) |
| ISO 15675:2016 | Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters |
| I.S. EN ISO 13504:2012 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
| IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| AAMI ISO 11135-1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN ISO 80601-2-12:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
| BS EN ISO 10993-16:2017 | Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables |
| DIN EN ISO 12870:2015-07 (Draft) | OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2012) |
| ISO/PAS 18761:2013 | Use and handling of medical devices covered by the scope of ISO/TC 84 Risk assessment on mucocutaneous blood exposure |
| I.S. EN ISO 9170-2:2008 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS |
| ISO 16671:2015 | Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
| NF EN ISO 10524-2 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| BS EN ISO 12870:2014 | Ophthalmic optics. Spectacle frames. Requirements and test methods |
| DIN EN ISO 7396-1:2016-09 | MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
| ISO 14708-6:2010 | Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
| CSA ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
| CSA Z7396.2 : 2002 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS |
| UNI EN ISO 10524-3 : 2013 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| AAMI ST15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| ISO/TR 16197:2014 | Nanotechnologies Compilation and description of toxicological screening methods for manufactured nanomaterials |
| ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| PREN 12184 : DRAFT 2011 | ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 25539-3:2011 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
| CEN/CLC/TR 14060:2014 | Medical device traceability enabled by unique device identification (UDI) |
| PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
| ISO 25841:2017 | Female condoms — Requirements and test methods |
| I.S. EN ISO 80601-2-13:2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
| UNI EN ISO 25539-3 : 2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| ISO 15798:2013 | Ophthalmic implants Ophthalmic viscosurgical devices |
| PREN ISO 11979-6 : DRAFT 2013 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013) |
| NF EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| CAN/CSA-C22.2 NO. 61010-1-12 (R2017) | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements (Tri-national standard, with UL 61010-1 and ANSI/ISA-61010-1 (82.02.01) |
| CSA C22.2 No. 60601-1-10:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| ISO/TR 15499:2016 | Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process |
| ISO 16840-10:2014 | Wheelchairs Resistance to ignition of non-integrated seat and back support cushions Part 10: Requirements and test methods |
| I.S. EN ISO 7197:2009 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| EN ISO 10524-1:2006 | Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) |
| ISO 7176-28:2012 | Wheelchairs — Part 28: Requirements and test methods for stair-climbing devices |
| EN ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| BS EN ISO 10524-2:2006 | Pressure regulators for use with medical gases Manifold and line pressure regulators |
| EN ISO 18369-2:2017 | Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017) |
| IEC 61326-2-6:2012 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| I.S. EN ISO 16671:2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
| IEC TR 80002-3:2014 | Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) |
| IEC TR 62653:2012 | Guideline for safe operation of medical equipment used for haemodialysis treatments |
| ISO/IEC 16085:2006 | Systems and software engineering — Life cycle processes — Risk management |
| I.S. EN ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
| NF EN ISO 11197 : 2016 | MEDICAL SUPPLY UNITS |
| IEC 60601-2-75:2017 | Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment |
| I.S. EN ISO 8836:2014 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| DIN EN ISO 22523:2007-04 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| DIN EN ISO 22794:2009-11 | Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
| DIN EN ISO 10651-6:2011-06 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| DIN EN 13060:2015-03 | SMALL STEAM STERILIZERS |
| DIN EN ISO 7439:2015-08 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| DIN EN 455-3:2015-07 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| DIN EN 13718-1:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| DIN EN ISO 10079-3:2014-09 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN ISO 10993-1:2010-04 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) |
| DIN EN ISO 15001:2012-06 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| DIN EN ISO 11608-1:2015-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| DIN EN ISO 11979-6:2015-02 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
| DIN EN ISO 19054:2006-09 | RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005 + AMD1:2016) |
| ISO 8835-3:2007 | Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems |
| ISO 7197:2006 | Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
| BS EN ISO 14155-2:2009 | Clinical investigation of medical devices for human subjects Clinical investigation plans |
| UNE-EN ISO 9626:2017 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) |
| BS EN ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods |
| BS EN ISO 10993-18:2009 | Biological evaluation of medical devices Chemical characterization of materials |
| BS EN ISO 23747:2015 | Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 80601-2-69:2014 | Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| ISO 22794:2007 | Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
| UNE-EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| BS EN ISO 21969:2009 | High-pressure flexible connections for use with medical gas systems |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| DIN EN ISO 10993-17:2009-08 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| UNE-EN ISO 26782:2010 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| IEC 61810-1:2015 | Electromechanical elementary relays - Part 1: General and safety requirements |
| BS EN ISO 15197:2015 | In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| I.S. EN ISO 10993-18:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) |
| EN ISO 9170-1:2008 | Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) |
| ONORM EN ISO 9170-1 : 2008 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM |
| UNE-EN 61010-1:2011 | Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 1: General requirements |
| I.S. EN 1789:2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
| UNE-EN 60601-1:2008 | Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
| ISA 61010-1 : 2008 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| EN ISO 80601-2-69:2014 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| EN ISO 10993-18:2009 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| EN ISO 8836:2014 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| I.S. EN ISO 11979-5:2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
| EN ISO 11979-5:2006 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
| EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
| CSA C22.2 No. 80601-2-12 : 2012(R2017) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| EN ISO 14698-1:2003 | Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003) |
| I.S. EN ISO 15883-1:2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| EN ISO 10993-17:2009 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| EN ISO 7494-2:2015 | Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
| EN ISO 11608-7:2017 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
| EN ISO 7396-2:2007 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
| EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| UNI EN ISO 5840 : 2009 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| UNI EN 1641 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| ONORM EN ISO 15798 : 2013 AMD 1 2018 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| UNI EN ISO 21647 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| UNI EN 1640 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| UNI EN ISO 10451 : 2010 | DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| UNI CEN ISO/TS 22367 : 2010 | MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT |
| UNI EN 1639 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| UNI EN ISO 16201 : 2007 | TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING |
| UNI EN ISO 10651-2 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNI EN 12184 : 2014 | ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 15883-1 : 2014 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| UNI EN ISO 17510-2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| UNI EN ISO 7396-2 : 2007 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS |
| UNI EN ISO 10993-13 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| UNI EN ISO 11979-9 : 2014 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES |
| UNI EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
| ONORM EN ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
| UNI EN ISO 21969 : 2010 | HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS |
| BS EN ISO 7405 : 2008 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| UNI EN ISO 14155-1 : 2009 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| UNI EN ISO 14937 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNI EN ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
| UNI EN 13544-1 : 2009 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI CEI EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| EN 15546-1:2008 | Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements |
| UNI EN ISO 10651-6 : 2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| ONORM EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
| UNI EN 14180 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 8185 : 2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| UNI EN 1422 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 14630 : 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| UNI EN ISO 10993-17 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES |
| UNI EN ISO 15001 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN |
| UNE-EN ISO 5361:2017 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
| UNI CEI EN 15546-1 : 2009 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| UNE-EN ISO 12870:2014 | Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012) |
| BS EN ISO 18113-2:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use |
| CSA Z10524-3 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| BS ISO 16571:2014 | Systems for evacuation of plume generated by medical devices |
| 02/560598 DC : DRAFT FEB 2002 | ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES |
| I.S. EN ISO 13958:2015 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
| PD ISO/PAS 18761:2013 | Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure |
| 13/30254047 DC : 0 | BS EN ISO 11979-6 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY |
| UNI EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| CSA Z10524-2 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| DIN EN ISO 13504:2012-10 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
| UNI EN ISO 11979-7 : 2015 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS |
| ISO/TR 16196:2016 | Nanotechnologies Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials |
| DIN EN ISO 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| 15/30282343 DC : 0 | BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES |
| 17/30356316 DC : 0 | BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| UNI EN 15908 : 2010 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| ONORM EN ISO 11979-7 : 2015 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014) |
| 14/30277509 DC : 0 | BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS |
| 15/30325469 DC : 0 | BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| IEEE 11073-10419-2015 | IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump |
| PREN 17180 : DRAFT 2017 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
| BS EN ISO 20072:2013 | Aerosol drug delivery device design verification. Requirements and test methods |
| 14/30244508 DC : 0 | BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| PD ISO/TR 15499:2016 | Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process |
| 07/30147554 DC : DRAFT SEP 2007 | BS ISO 16628 - TRACHEOBRONCHIAL TUBES - SIZING AND MARKING |
| 08/30192448 DC : DRAFT DEC 2008 | BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| UNI CEN/TS 15277 : 2007 | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| AAMI/IEC TIR80002-1:2009 | MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE |
| 05/30128342 DC : DRAFT AUG 2005 | ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING, AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| 09/30186527 DC : 0 | BS EN ISO 23908-1 - SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - PART 1: SHARPS PROTECTION FEATURES FOR SINGLE-USED HYPODERMIC NEEDLES, CATHETERS, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING |
| PD IEC/TR 80001-2-3:2012 | Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks |
| DIN 820-120:2012-09 | STANDARDIZATION - PART 120: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:1999) |
| 13/30250915 DC : 0 | BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
| DIN EN ISO 15194:2009-10 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| 09/30193293 DC : DRAFT MAR 2009 | BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| 06/30147232 DC : DRAFT OCT 2006 | IEC 60601-1-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| ISO 16038:2017 | Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
| 15/30304642 DC : 0 | BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES |
| I.S. EN ISO 21647:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| PD ISO/TR 27809:2007 | Health informatics. Measures for ensuring patient safety of health software |
| 14/30251609 DC : 0 | BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| BS ISO 8009:2014 | Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests |
| 08/30182164 DC : DRAFT MAY 2008 | BS ISO 31000 - RISK MANAGEMENT - PRINCIPLES AND GUIDELINES ON IMPLEMENTATION |
| DIN EN 1865-1:2015-08 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
| BS ISO 18835:2015 | Inhalational anaesthesia systems. Draw-over anaesthetic systems |
| CSA ISO 15197 : 2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| I.S. EN ISO 7396-2:2007 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS |
| I.S. EN ISO 14155-1:2009 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN 556-2:2015 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| BS ISO 26722 : 2014 | WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES |
| ISO/TS 25238:2007 | Health informatics Classification of safety risks from health software |
| 13/30264413 DC : 0 | BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| AAMI ISO TIR 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| UNI EN ISO 18113-2 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| PD IEC/TR 80002-3:2014 | Medical device software Process reference model of medical device software life cycle processes (IEC 62304) |
| 18/30356489 DC : DRAFT APR 2018 | BS EN 60601-1-10:2008 AMENDMENT 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| BS EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies |
| BS ISO 15621:2011 | Urine-absorbing aids. General guidelines on evaluation |
| PREN 455-3 : DRAFT 2013 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| I.S. EN ISO 11135-1:2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| PD IEC/TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls |
| PREN ISO 11197 : DRAFT 2012 | MEDICAL SUPPLY UNITS (ISO/DIS 11197:2012) |
| 15/30289037 DC : 0 | BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE |
| BS EN ISO 25539-2:2012 | Cardiovascular implants. Endovascular devices Vascular stents |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| 16/30288024 DC : 0 | BS EN ISO 15883-4 - WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES |
| PD IEC/TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples |
| UNE-EN ISO 20857:2013 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| 13/30283636 DC : 0 | BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS |
| ISO/IEC 15026-3:2015 | Systems and software engineering — Systems and software assurance — Part 3: System integrity levels |
| I.S. EN ISO 11979-7:2014 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA (ISO 11979-7:2018) |
| IEEE DRAFT 1073.0.1 : D01J 2006 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - TECHNICAL REPORT - GUIDELINES FOR THE USE OF RF WIRELESS TECHNOLOGY |
| 16/30339096 DC : 0 | BS EN ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION |
| BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| 09/30180393 DC : 0 | BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| 11/30208525 DC : 0 | BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| 13/30259011 DC : 0 | BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE |
| EN ISO 7396-1:2016 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016) |
| 14/30281859 DC : 0 | BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| 14/30302761 DC : 0 | BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS) |
| ISO 15198:2004 | Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
| ANSI/AAMI/IEC TIR80001-2-1:2012 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES |
| 13/30233325 DC : 0 | BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 11979-10:2007 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES (ISO 11979-10:2018) |
| BS ISO 29942:2011 | Prophylactic dams. Requirements and test methods |
| 17/30335550 DC : 0 | BS EN ISO 11979-10 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES |
| CAN/CSA-ISO/IEC 15026-3:16 | Systems and software engineering - Systems and software assurance - Part 3: System integrity levels (Adopted ISO/IEC 15026-3:2015, second edition, 2015-12-01) |
| 14/30257546 DC : 0 | BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 13504 : 2012 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
| ISO/TR 10993-22:2017 | Biological evaluation of medical devices — Part 22: Guidance on nanomaterials |
| UNI CEI EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| 17/30302770 DC : 0 | BS ISO 13779-3 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 3: CHEMICAL ANALYSIS AND CHARACTERIZATION OF CRYSTALLINITY RATIO AND PHASE PURITY |
| BS EN ISO 15378:2017 | Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| EN 61326-2-6:2013 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 11/30219211 DC : 0 | BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| BS EN ISO 11073-30400:2012 | Health informatics. Point-of-care medical device communication Interface profile. Cabled Ethernet |
| DIN EN ISO 7198:2017-07 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| BS EN ISO 5361:2016 | Anaesthetic and respiratory equipment. Tracheal tubes and connectors |
| UNE-EN ISO 80369-3:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
| 15/30278530 DC : 0 | BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| BS EN ISO 11073-10441:2017 | Health informatics. Personal health device communication Device specialization. Cardiovascular fitness and activity monitor |
| 07/30164697 DC : 0 | ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 16/30280931 DC : DRAFT APR 2016 | BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| 09/30189968 DC : DRAFT JAN 2009 | BS EN 13544-1 AMD1 - RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| 13/30272807 DC : 0 | BS ISO 18835 - INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT |
| BS EN ISO 18113-5:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing |
| AAMI 26722 : 2014 | WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS AND RELATED THERAPIES |
| 03/314215 DC : DRAFT OCT 2003 | ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| PREN ISO 80601-2-55 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| BS EN 1865-4:2012 | Patient handling equipment used in road ambulances Foldable patient transfer chair |
| 12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 06/30146511 DC : 0 | BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| UNI EN ISO 8835-3 : 2010 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| DIN EN 1865-3:2015-05 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| UNI EN ISO 7197 : 2009 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| 07/30168572 DC : 0 | BS IEC 61010-1 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| PD IEC/TR 80002-1:2009 | Medical device software Guidance on the application of ISO 14971 to medical device software |
| 16/30337200 DC : 0 | BS EN ISO 11979-8 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| BIS IS/ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| I.S. EN ISO 12417-1:2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
| DD ISO/TS 22367 : 2008 | MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT |
| 03/103293 DC : DRAFT JAN 2003 | BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 10/30208681 DC : DRAFT SEP 2010 | BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
| EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| BS ISO 19233-1:2017 | Implants for surgery. Orthopaedic joint prosthesis Procedure for producing parametric 3D bone models from CT data of the knee |
| 07/30145258 DC : 0 | BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| 11/30237926 DC : 0 | BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| UNE-EN 1865-4:2012 | Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
| NF ISO 18562-1 : 2017 | BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| AAMI ISO 10993-13:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| NFS 99 171 : 2006 | MAINTENANCE OF MEDICAL DEVICES - MODEL AND DEFINITION FOR ESTABLISHMENT AND MANAGEMENT OF THE MEDICAL DEVICE SECURITY, QUALITY AND MAINTENANCE REGISTER (RSQM) |
| ISO 29943-2:2017 | Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports |
| CSA ISO TR 14969 : 2005 : R2015 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| AAMI TIR52 : 2014 | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 14708-4 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| 09/30197784 DC : 0 | BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| CSA C22.2 No. 61010.1 : 2012 : FR | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 13408-6:2005 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| I.S. EN ISO 7396-1:2016 | MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
| UNE-EN ISO 23640:2015 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
| UNE-EN ISO 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| DD CEN/TS 15260:2006 | Health informatics. Classification of safety risks from health informatics products |
| UNI EN ISO 25539-2 : 2013 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
| CSA Z10651.2 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CSA Z21647:2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| ISO/TR 12417-2:2017 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
| BS EN ISO 11135:2014 | Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices |
| CSA Z10651.2: 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| UNI EN ISO 20857 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| DIN EN ISO 25539-2:2013-05 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| AAMI ISO 13408-1:2008 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| NF EN ISO 25539-3 : 2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| AAMI ISO 12417-1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| PREN 17141 : DRAFT 2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| CSA ISO TR 14969 :2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| AAMI ISO 10993-16:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| ANSI Z80.11 : 2012 : R2017 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| UNE-EN ISO 22442-2:2016 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
| 17/30325386 DC : 0 | BS ISO 18250-1- CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 1: GENERAL REQUIREMENTS AND COMMON TEST METHODS |
| DIN EN ISO 20857:2013-08 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| 15/30278537 DC : 0 | BS ISO 18562-3 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 3: TESTS FOR EMISSIONS OF VOLATILE ORGANIC COMPOUNDS (VOCS) |
| I.S. EN ISO 11608-5:2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
| ISO 80601-2-67:2014 | Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
| CSA C22.2 No. 80601-2-55 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs) |
| CSA ISO 11137-2 : 2016 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| S.R. CEN/TR 16386:2013 | DENTISTRY - GUIDELINES FOR HANDLING METHACRYLATE-BASED MATERIALS IN THE DENTAL LABORATORY |
| I.S. EN ISO 13017:2012 | DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012) |
| IEEE 730-2014 | IEEE Standard for Software Quality Assurance Processes |
| I.S. EN ISO 7886-1:1998 | STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017) |
| I.S. EN ISO 18113-4:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009) |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| AAMI ISO 27185 : 2012 | CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
| IEEE/ISO/IEC 16085-2006 | ISO/IEC/IEEE International Standard - Systems and Software Engineering - Life Cycle Processes - Risk Management |
| ISO/TS 20405:2018 | Health informatics Framework of event data and reporting definitions for the safety of health software |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ANSI/AAMI/ISO 80369-6:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS |
| CAN/CSA-C22.2 NO. 80601-2-67:17 | Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations) |
| AAMI/ISO TIR17665-2:2009(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| ANSI/AAMI/ISO 14708-3:2017 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| EN ISO 14607:2018 | Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08) |
| ANSI/AAMI/ISO 13408-7:2012(R2018) | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| ANSI/AAMI/ISO 14708-1:2014 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 15002:2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| ISO/TR 13014:2012 | Nanotechnologies Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment |
| I.S. EN ISO 26722:2015 | WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014) |
| EN ISO 10524-2:2006 | Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
| I.S. EN ISO 80601-2-72:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
| I.S. EN 1865-1:2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
| I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| I.S. EN 15908:2010 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| UNI EN ISO 23907 : 2013 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS CONTAINERS |
| ISO 14708-5:2010 | Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
| PD ISO/TS 19930:2017 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| ISO/TS 17822-1:2014 | In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions |
| ISO 17218:2014 | Sterile acupuncture needles for single use |
| ISO 10524-1:2018 | Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| ISO 14708-4:2008 | Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps |
| BS EN ISO 23640:2015 | In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents |
| UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| BS EN ISO 10524-3 : 2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| ISO 13485 - PRACTICAL GUIDE : 2016 | ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE |
| UNE-EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
| BS EN 12183:2014 | Manual wheelchairs. Requirements and test methods |
| I.S. EN ISO 7405:2009 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
| UNI EN ISO 11135 : 2014 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| IEEE 11073-10427-2016 | IEEE Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices |
| UNE-EN 12183:2014 | Manual wheelchairs - Requirements and test methods |
| DIN EN ISO 10524-3:2013-06 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005 + AMD 1:2013) |
| CEI EN 80001-1 : 2016 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES |
| PD IEC/TR 62809:2013 | Summary of requirements and tests for products in the scope of IEC 60601-2-66 |
| DIN EN ISO 7405:2013-12 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
| I.S. EN ISO 15223-1:2016 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
| UNE-EN 13060:2015 | Small steam sterilizers |
| AAMI ISO 26782 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
| UNE-EN ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015) |
| ISO 13779-6:2015 | Implants for surgery Hydroxyapatite Part 6: Powders |
| UNE-EN ISO 7396-1:2016 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016) |
| EN ISO 11979-7:2018 | Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018) |
| ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| UNI EN ISO 7405 : 2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| IEC TR 80001-2-3:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| ISO 15674:2016 | Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| ISO 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
| ISO 27185:2012 | Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements |
| DIN EN ISO 9170-1:2016-09 (Draft) | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM |
| EN ISO 20608:2018 | Dentistry - Powder jet handpieces and powders (ISO 20608:2018) |
| ISO 10524-2:2018 | Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators |
| BS EN ISO 11197:2009 | Medical supply units |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| BS EN ISO 16671 : 2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO 13022:2012 | Medical products containing viable human cells — Application of risk management and requirements for processing practices |
| DIN EN ISO 80369-1:2015-09 (Draft) | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO 18835:2015 | Inhalational anaesthesia systems Draw-over anaesthetic systems |
| ISO 8009:2014 | Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests |
| ISO/TS 18339:2015 | Endotherapy devices — Eyepiece cap and light guide connector |
| ISO 18369-2:2017 | Ophthalmic optics — Contact lenses — Part 2: Tolerances |
| IEC 62820-3-2:2018 | Building intercom systems - Part 3-2: Application guidelines - Advanced security building intercom systems (ASBIS) |
| ISO 10651-5:2006 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators |
| UNE-EN ISO 15883-1:2009 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| DIN EN 14180:2014-09 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| DIN EN ISO 10079-1:2016-05 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| DIN EN ISO 16201:2006-12 | Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006) |
| DIN EN ISO 10079-2:2014-09 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| BS EN ISO 8185:2007 | Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 13504:2012 | Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment |
| BS EN ISO 11979-5:2006 | Ophthalmic implants. Intraocular lenses Biocompatibility |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
| ISO 18113-2:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use |
| UNE-EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| UNE-EN 556-2:2016 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| BS EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| UNE-EN ISO 10079-3:2014 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 17510-2:2007 | Sleep apnoea breathing therapy Part 2: Masks and application accessories |
| ISO 21969:2009 | High-pressure flexible connections for use with medical gas systems |
| IEC TS 62850:2013 | Safety requirements for electrical equipment for measurement, control, and laboratory use - General requirements for equipment intended to be used in educational establishments by children |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 26782:2009 | Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans |
| BS EN ISO 10651-6:2009 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 11979-9:2006 | Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses |
| ISO 9170-2:2008 | Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| BS EN ISO 19054 : 2006 | RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005) |
| BS EN ISO 17665-1:2006 | Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects General requirements |
| PD IEC/TR 80001-2-5:2014 | Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems |
| BS EN ISO 10079-3:2014 | Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source |
| IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| BS EN ISO 14937:2009 | Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 80601-2-72:2015 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| BS EN ISO 9680:2014 | Dentistry. Operating lights |
| ONORM EN ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| BS EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods |
| ISO 20072:2009 | Aerosol drug delivery device design verification Requirements and test methods |
| UNE-EN ISO 4074:2016 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
| UNE-EN ISO 15223-1:2017 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) |
| UNE-EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| UNE-EN 1041:2009 | Information supplied by the manufacturer of medical devices |
| UNE-EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
| BS EN ISO 11979-6:2014 | Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing |
| BS EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications |
| ISO 11979-6:2014 | Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing |
| UNE-EN ISO 10993-12:2013 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| ISO 5840-3:2013 | Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| UNE-EN ISO 11979-7:2015 | Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014) |
| 00/565497 DC : DRAFT DEC 2000 | BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN 1789 : 2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| ISO 26722:2014 | Water treatment equipment for haemodialysis applications and related therapies |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 11979-8:2017 | Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
| ISO 15621:2017 | Absorbent incontinence aids for urine and/or faeces — General guidelines on evaluation |
| ISO 16672:2015 | Ophthalmic implants Ocular endotamponades |
| I.S. EN 13718-1:2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| ISO 10535:2006 | Hoists for the transfer of disabled persons Requirements and test methods |
| ISO 25539-2:2012 | Cardiovascular implants Endovascular devices Part 2: Vascular stents |
| UNE-EN 1642:2012 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN 13060 : 2014 | SMALL STEAM STERILIZERS |
| UNE-EN 1789:2007 | Medical vehicles and their equipment - Road ambulances |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| ISO 14534:2011 | Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
| BS EN ISO 10651-2:2004 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients |
| ISO 11979-5:2006 | Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods |
| DIN EN ISO 10993-13:2010-11 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| I.S. EN ISO 10993-1:2009+AC:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| I.S. EN 455-3:2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices — Requirements and tests |
| BS EN 1041 : 2008 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| IEC TR 80001-2-5:2014 | Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
| IEC 62570:2014 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| DIN EN ISO 11979-8:2016-04 (Draft) | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| ISO/IEEE 11073-30400:2012 | Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet |
| ISO 23747:2015 | Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| ISO 13017:2012 | Dentistry Magnetic attachments |
| ISO 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products |
| ISO 22523:2006 | External limb prostheses and external orthoses — Requirements and test methods |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| UNE-EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| ISO 5840-2:2015 | Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
| ISO 11608-1:2014 | Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
| UNE-EN ISO 14937:2010 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| UNE-EN ISO 14630:2013 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| BS EN 14180:2014 | Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing |
| UNE-EN 45502-2-3:2010 | Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| BS EN ISO 11073-30200 : 2005 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED |
| BS EN ISO 5840:2009 | Cardiovascular implants. Cardiac valve prostheses |
| UNE-EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
| ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| I.S. EN ISO 11979-9:2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006) |
| BS EN ISO 10451:2010 | Dentistry. Contents of technical file for dental implant systems |
| ISO 18113-3:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use |
| UNE-EN ISO 11979-6:2015 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
| ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| BS EN 14065:2016 | Textiles. Laundry processed textiles. Biocontamination control system |
| ISO 19054:2005 | Rail systems for supporting medical equipment |
| BS EN ISO 10993-13:2010 | Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices |
| ISO 4074:2015 | Natural rubber latex male condoms Requirements and test methods |
| UNE-EN ISO 7864:2017 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| ISO 16201:2006 | Technical aids for persons with disability — Environmental control systems for daily living |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 23908:2011 | Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 9680:2014 | Dentistry Operating lights |
| ISO 10451:2010 | Dentistry — Contents of technical file for dental implant systems |
| BS EN ISO 15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| UNI EN ISO 80601-2-13 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
| UNE-EN ISO 11979-8:2017 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
| BS EN ISO 22794:2009 | Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
| ISO/IEEE 11073-20601:2016 | Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol |
| BS EN 12182:2012 | Assistive products for persons with disability. General requirements and test methods |
| 04/30106146 DC : DRAFT MARCH 2004 | BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN 1641:2004 | Dentistry. Medical devices for dentistry. Materials |
| UNE-EN ISO 10993-13:2010 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| BS EN ISO 13485:2016 | Medical devices. Quality management systems. Requirements for regulatory purposes |
| DIN EN 80369-5:2017-10 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017) |
| EN ISO 11073-10419:2016 | Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03) |
| EN 15908:2010 | Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
| EN ISO 11073-20601:2016 | Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016) |
| EN 16372:2014 | Aesthetic surgery services |
| EN 1865-2:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| EN ISO 80601-2-72:2015 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| EN ISO 26722:2015 | Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014) |
| EN ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
| EN ISO 18113-5:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| EN ISO 5361:2016 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| EN ISO 10651-2:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
| EN ISO 16201:2006 | Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006) |
| EN ISO 7197:2009 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| UNI EN ISO 9680 : 2015 | DENTISTRY - OPERATING LIGHTS |
| EN ISO 22803:2005 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| EN ISO 23640:2015 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
| EN ISO 14155-2:2009 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
| EN ISO 11979-6:2014 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
| EN ISO 10651-6:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
| EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
| EN 1641:2009 | Dentistry - Medical devices for dentistry - Materials |
| EN ISO 17510-2:2009 | Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| EN 45502-2-3:2010 | Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
| EN ISO 11608-5:2012 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| EN 1865-4:2012 | Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
| EN ISO 10451:2010 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| EN ISO 10079-3:2014 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| EN 14065:2016 | Textiles - Laundry processed textiles - Biocontamination control system |
| EN ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015) |
| EN 14931:2006 | Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
| EN ISO 22794:2009 | Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
| EN ISO 11137-3:2017 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) |
| EN ISO 20857:2013 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| EN ISO 13940:2016 | Health informatics - System of concepts to support continuity of care (ISO 13940:2015) |
| EN 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
| EN 1865-3:2012+A1:2015 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
| EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
| EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
| EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| EN 1865-1:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
| EN ISO 11073-30400:2012 | Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012) |
| EN ISO 15194:2009 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) |
| EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| EN ISO 10524-4:2008 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
| EN ISO 15001:2011 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| EN ISO 15621:2017 | Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017) |
| EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| EN ISO 9170-2:2008 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
| EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| EN ISO 11073-10441:2017 | Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN ISO 23907:2012 | Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012) |
| EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| EN ISO 13408-7:2015 | Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
| EN ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| EN ISO 4074:2015 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
| EN ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) |
| EN ISO 23747:2015 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015) |
| EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
| EN ISO 13504:2012 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012) |
| EN ISO 10993-13:2010 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| DIN ISO 10083:2008-12 | OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS |
| 08/30156451 DC : DRAFT AUG 2008 | BS EN ISO 10993-13 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| 14/30292011 DC : 0 | BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
| BS EN 1865-3 : 2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
| 12/30262133 DC : 0 | BS ISO 11197 - MEDICAL SUPPLY UNITS |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| AAMI ISO TIR 12417 : 2011 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
| AAMI ISO 14155-1 : 2003 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 81060-1:2012-08 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| DIN EN ISO 5840-3:2013-06 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| I.S. EN ISO 5359:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| BS ISO 13408-7 : 2012 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS |
| I.S. EN ISO 19054:2006 | RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005) |
| BS ISO 11712:2009 | Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors |
| CEI EN 61082-1 : 2016 | PREPARATION OF DOCUMENTS USED IN ELECTROTECHNOLOGY - PART 1: RULES |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN 980:2008 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| 13/30290370 DC : 0 | BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES |
| BS EN ISO 8835-3 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| ANSI/AAMI/ISO 22442-2:2016 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
| 15/30246774 DC : 0 | BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| CAN/CSA-ISO 13485:16 | Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01) |
| I.S. EN ISO 14155:2011 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
| BS EN 16372:2014 | Aesthetic surgery services |
| IEEE 11073-10441-2013 | Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor |
| 10/30203224 DC : 0 | BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
| I.S. EN ISO 10651-2:2009 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| ISO 18746:2016 | Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use |
| PD IEC/PAS 63077:2016 | Good refurbishment practices for medical imaging equipment |
| UNI EN ISO 10524-4 : 2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| DD ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| I.S. EN ISO 23640:2015 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011) |
| I.S. EN ISO 13408-1:2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
| ISO/IEEE 11073-10427:2018 | Health informatics — Personal health device communication — Part 10427: Device specialization — Power status monitor of personal health devices |
| PD ISO/TR 10993-22:2017 | Biological evaluation of medical devices Guidance on nanomaterials |
| BS ISO 18362:2016 | Manufacture of cell-based health care products. Control of microbial risks during processing |
| UNE-EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| 09/30193290 DC : DRAFT MAR 2009 | BS EN 12183 - MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
| BS ISO 27185:2012 | Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements |
| DIN EN ISO 18113-1:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| I.S. EN ISO 80369-1:2010 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| 14/30281557 DC : 0 | BS EN ISO 7198 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES |
| BS EN ISO 10524-4:2008 | Pressure regulators for use with medical gases Low-pressure regulators |
| BS ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| DIN EN ISO 80369-20:2015-09 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015); German version EN ISO 80369-20:2015 |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| DIN EN 15908 E : 2011 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| UNE-EN ISO 13940:2016 | Health informatics - System of concepts to support continuity of care (ISO 13940:2015) |
| 12/30210881 DC : DRAFT APR 2012 | BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| PD ISO/TS 18339:2015 | Endotherapy devices. Eyepiece cap and light guide connector |
| BS EN ISO 25539-3:2011 | Cardiovascular implants. Endovascular devices Vena cava filters |
| 16/30335531 DC : 0 | BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 03/100426 DC : DRAFT JAN 2003 | BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| 16/30312836 DC : 0 | BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS |
| BS ISO 7176-28:2012 | Wheelchairs Requirements and test methods for stair-climbing devices |
| 10/30213842 DC : 0 | BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
| CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
| DIN EN ISO 9170-2:2009-09 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS |
| BIS IS/ISO 10524-4 : 2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| BS EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications General requirements |
| BS ISO 29943-2:2017 | Condoms. Guidance on clinical studies Female condoms, clinical function studies based on self-reports |
| S.R. CEN ISO TS 22367:2010 | MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT |
| DD CEN ISO/TS 17665-2:2009 | Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
| ANSI/AAMI BE83:2006(R2011) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
| ANSI/AAMI/ISO 80369-5:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
| AAMI ISO 7199 : 2009 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| 07/30163763 DC : 0 | BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS |
| BS ISO 16840-10:2014 | Wheelchairs. Resistance to ignition of non-integrated seat and back support cushions Requirements and test methods |
| AAMI ISO 10993-1 : 2009 : R2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| PD CEN ISO/TR 14969:2005 | Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| 14/30280574 DC : 0 | BS ISO 16840-10 - WHEELCHAIR - RESISTANCE TO IGNITION OF NON-INTEGRATED SEAT AND BACK SUPPORT CUSHIONS - PART 10: REQUIREMENTS AND TEST METHODS |
| 17/30332162 DC : 0 | BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| CEI EN 60601-1-2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| PD ISO/IEC GUIDE 51:2014 | Safety aspects. Guidelines for their inclusion in standards |
| PD ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| BS EN 80601-2-35 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| 06/30146518 DC : 0 | BS ISO 18113-3 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| CSA Z17665-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| BS EN ISO 9170-1:2008 | Terminal units for medical gas pipeline systems Terminal units for use with compressed medical gases and vacuum |
| S.R. CEN ISO TS 17665-2:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| I.S. EN 13060:2014 | SMALL STEAM STERILIZERS |
| I.S. EN ISO 80369-20:2015&LC:2015 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS (ISO 80369-20:2015) |
| 15/30278534 DC : 0 | BS ISO 18562-2 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 2: TESTS FOR EMISSIONS OF PARTICULATE MATTER |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| BS EN 62366-1:2015 | Medical devices Application of usability engineering to medical devices |
| I.S. EN ISO 18113-2:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009) |
| UNI EN ISO 23908 : 2013 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING |
| 11/30227618 DC : 0 | BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
| DIN EN ISO 5367:2015-02 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| 04/30081057 DC : DRAFT AUG 2004 | EN ISO 10535 - HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| NF EN 80601-2-35 : 2010 AMD 1 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| 17/30348182 DC : 0 | BS EN ISO 23907 - SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - PART 1: SINGLE-USE SHARPS CONTAINERS |
| 04/30079743 DC : DRAFT APR 2004 | ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 17/30329441 DC : 0 | BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| CSA Z10083 : 2008 : R2013 | OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS |
| CSA Z11137-2 : 2007 : R2012 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| ISO 19611:2017 | Traditional Chinese medicine — Air extraction cupping device |
| I.S. EN ISO 5367:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| CSA ISO TR 14969 : 2005 : R2010 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| CSA Z10524-4 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| CEI EN 61010-2-101 : 2003 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| NF EN 60601-1-10 : 2008 AMD 1 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| EN ISO 10993-12:2012 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| I.S. EN ISO 11073-10425:2016 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10425: DEVICE SPECIALIZATION - CONTINUOUS GLUCOSE MONITOR (CGM) (ISO 11073-10425:2016) |
| EN ISO 11073-10427:2018 | Health informatics - Personal health device communication - Part 10427: Device specialization - Power status monitor of personal health devices(ISO/IEEE 11073-10427:2018) |
| CAN/CSA-Z10524-4:12 (R2017) | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (Adopted ISO 10524-4:2008, first edition, 2008-06-01, with Canadian deviations) |
| ANSI/AAMI/ISO 13022:2012 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
| NF EN 61326-2-6 : 2013 | ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN-VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| AAMI ISO TIR 17665-3:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| AAMI ISO 14708-4:2008(R2011) | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| 04/30084855 DC : 0 | PREN ISO 10083 - OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS |
| UNI EN ISO 18113-3 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| ISO 11249:2018 | Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies |
| I.S. EN ISO 80369-7:2017 COR 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
| DIN EN ISO 80601-2-69:2014-12 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| UNI EN ISO 15194 : 2009 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| ISO 11195:2018 | Gas mixers for medical use — Stand-alone gas mixers |
| TR 102 434 : 1.1.1 | ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); SHORT RANGE DEVICES (SRD); ALTERNATIVE INTERFERENCE MITIGATION TECHNOLOGIES TO LISTEN BEFORE TALK (LBT) FOR ULTRA LOW POWER ACTIVE MEDICAL IMPLANTS (ULP-AMI) OPERATING FROM 403,5 MHZ TO 403,8 MHZ WITH A DUTY CYCLE OF LESS THAN OR EQUAL TO 0,01%; SYSTEM REFERENCE DOCUMENT |
| CSA Z21647 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| UNE-EN ISO 16671:2016 | Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
| I.S. EN ISO 11073-30400:2012 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET (ISO 11073-30400:2012) |
| CEI UNI EN ISO 80369-3 : 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
| IEEE/ANSI C63.27-2017 | American National Standard for Evaluation of Wireless Coexistence |
| ANSI/AAMI/ISO 11137-3:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL |
| AAMI 13958 : 2014 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
| PREN ISO 11608-1 : DRAFT 2010 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
| CSA C22.2 No. 60601-1-10 : 2009 : INC : AMD 1 : 2014 : R201400 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| IEEE 11073-10425-2014 | Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM) |
| ONORM EN ISO 5840-1 : 2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| I.S. EN ISO 9170-1:2008 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM |
| UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| UNE-EN ISO 23907:2013 | Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012) |
| I.S. EN ISO 18113-5:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009) |
| I.S. EN 1865-4:2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
| NF EN ISO 10524-3 : 2006 AMD 1 2013 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| I.S. CEN TS 15277:2006 | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| BS ISO 7199 : 2009 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| I.S. EN ISO 80601-2-55:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018) |
| CSA C22.2 No. 61010.1 : 2012 : INC : UPD 2 :2016 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| BS EN 1865-1 : 2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
| IEEE 11073-10418-2011 | IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor |
| ANSI/AAMI/ISO 10993-12:2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| I.S. EN ISO 18113-3:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
| BS IEC 82304-1 : 2016 | HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| I.S. EN ISO 11135:2014 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| I.S. EN ISO 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| EN ISO 12870:2018 | Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016) |
| ASTM F 3037 : 2015 | Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020) |
| CSA Z5359 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
| ISO/TR 19244:2014 | Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters |
| CEI 62-143 : 2007 | MAPPING BETWEEN THE CLAUSES OF THE THIRD EDITION OF IEC 60601-1 AND THE 1988 EDITION AS AMENDED |
| CEI EN 62570 : 2016 | STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
| I.S. EN ISO 8835-3:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| I.S. EN 45502-2-3:2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| ISO/TR 14283:2018 | Implants for surgery Essential principles of safety and performance |
| BS EN 62304 : 2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| I.S. EN ISO 11608-7:2017 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| I.S. EN ISO 80601-2-69:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
| DIN EN ISO 11608-7:2015-08 (Draft) | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| EN ISO 10993-16:2017 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017) |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| BS EN ISO 23908:2013 | Sharps injury protection. Requirements and test methods. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| BS EN ISO 11073-10425:2016 | Health informatics. Personal health device communication Device specialization. Continuous glucose monitor (CGM) |
| DIN EN ISO 23908:2013-10 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
| DIN EN ISO 23640:2015-12 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011) |
| ISO 20608:2018 | Dentistry — Powder jet handpieces and powders |
| I.S. EN ISO 11197:2016 | MEDICAL SUPPLY UNITS (ISO 11197:2016) |
| I.S. EN ISO 80369-6:2016 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO/IEC/DIS 80369-6:2014) |
| I.S. EN ISO 7199:2017 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| UNE-EN ISO 11608-7:2018 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
| DIN EN ISO 5359:2015-02 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| ISO 17966:2016 | Assistive products for personal hygiene that support users Requirements and test methods |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| IEEE 11073-20601-2014 REDLINE | IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol |
| ISO/IEEE 11073-10422:2017 | Health informatics — Personal health device communication — Part 10422: Device specialization — Urine analyser |
| UNE-EN 1865-2:2011 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
| IEEE 11073-10424-2014 | IEEE Standard - Health informatics--Personal health device communication - Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE) |
| ASTM F 2848 : 2017 : REDLINE | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| PREN ISO 15197 : DRAFT 2011 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| UNI EN ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| UNI EN ISO 22794 : 2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| ASTM F 3127 : 2016 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
| ASTM F 3172 : 2015 | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| CSA C22.2 No. 61010.1 : 2012 : INC : UPD 2 : 2016 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| EN ISO 17664:2017 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) |
| EN ISO 11073-10425:2016 | Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016) |
| ONORM EN ISO 7405 : 2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD 1:2013) |
| ISO 8600-1:2015 | Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements |
| NF EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS |
| ISO/TS 13131:2014 | Health informatics Telehealth services Quality planning guidelines |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| I.S. EN ISO 20072:2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| I.S. EN 62366:2009 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| IEC TR 62809:2013 | Summary of requirements and tests to products in the scope of IEC 60601-2-66 |
| I.S. EN ISO 10524-2:2006 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| I.S. EN ISO 15378:2017 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| DIN EN ISO 7396-2:2007-07 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
| DIN EN ISO 15883-1:2014-10 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014) |
| DIN EN ISO 10535:2007-04 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| DIN EN 14065:2016-08 | TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
| DIN EN ISO 15197:2015-12 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
| UNE-EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| UNE-EN 285:2016 | Sterilization - Steam sterilizers - Large sterilizers |
| BS EN 1422:2014 | Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods |
| BS EN ISO 17510-2:2009 | Sleep apnoea breathing therapy Masks and application accessories |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| UNE-EN ISO 15001:2012 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| BS EN ISO 7396-2:2007 | Medical gas pipeline systems Anaesthetic gas scavenging disposal systems |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| ISO/TS 22367:2008 | Medical laboratories Reduction of error through risk management and continual improvement |
| UNE-EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| BS EN ISO 11135-1:2007 | Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
| BS EN ISO 11137-3:2017 | Sterilization of health care products. Radiation Guidance on dosimetric aspects of development, validation and routine control |
| BS EN ISO 11137-2:2015 | Sterilization of health care products. Radiation Establishing the sterilization dose |
| ISO 13940:2015 | Health informatics — System of concepts to support continuity of care |
| BS EN ISO 10993-17:2009 | Biological evaluation of medical devices Establishment of allowable limits for leachable substances |
| PD IEC/TS 62850:2013 | Safety requirements for electrical equipment for measurement, control, and laboratory use. General requirements for equipment intended to be used in educational establishments by children |
| ISO 11608-5:2012 | Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| BS EN ISO 21647:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| ISO 22803:2004 | Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| BS EN ISO 11608-1:2015 | Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| EN ISO 7199:2017 | Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) |
| ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
| BS EN 1642:2011 | Dentistry. Medical devices for dentistry. Dental implants |
| ISO 7396-2:2007 | Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems |
| BS EN ISO 16672:2015 | Ophthalmic implants. Ocular endotamponades |
| PD IEC/TR 62354:2014 | General testing procedures for medical electrical equipment |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
| 15/30273313 DC : 0 | BS EN ISO 11608-7 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| BS EN ISO 4074:2015 | Natural rubber latex male condoms. Requirements and test methods |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| DIN EN ISO 5840:2009-08 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| DIN EN ISO 80369-7:2017-10 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
| EN 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| CEN ISO/TS 22367:2010 | Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009) |
| DIN EN ISO 10079-2:2000-03 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
| DIN EN ISO 11608-7:2017-10 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| EN ISO 81060-1:2012 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| CEN/TR 16386:2013 | Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory |
| CEN/TS 14507-2:2003 | Inhalational nitric oxide systems - Part 2: Supply systems |
| DIN EN ISO 8185:2009-07 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| DIN EN ISO 14155-2:2009-11 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
| CEN/TS 15277:2006 | Non-active surgical implants - Injectable implants |
| EN ISO 5840:2009 | Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
| DIN EN ISO 14937:2010-03 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| EN ISO 10535:2006 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| EN 15546-1 : 2008 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| EN 80001-1:2011 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| EN ISO 21969:2009 | High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| EN 61010-2-101:2017 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| UNI EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| DIN EN ISO 10079-3:2000-03 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
| ONORM EN ISO 13408-1 : 2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
| CSA Z9170.1 : 2011 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES, VACUUM, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
| ONORM EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| CSA Z10651-5 : 2008 : R2018 | Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators |
| CSA C22.2 No. 60601.1.8 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| UNE-EN 1865-3:2012 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
| CSA C22.2 No. 60601.1.2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| CSA Z10651-5 : 2008 : R2013 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| CSA Z10651-5 : 2008 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| CSA C22.2 No. 61010.2.101 : 2015 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
| CSA C22.2 No. 60601.1.8 : 2008 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
| CSA ISO 5361 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| ONORM EN ISO 18113-3 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
| ONORM EN 455-3 : 2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| CAN/CSA-C22.2 NO. 60601-1-8:08 (R2018) | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10) |
| CSA Z23747:2008 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
| CSA Z23747 : 2008 : R2013 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
| ONORM EN ISO 18113-2 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009) |
| CAN/CSA-ISO 10079-1:16 | Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01) |
| CSA Z9170.1 : 2011 : R2015 | TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES, VACUUM, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
| CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| ONORM EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| ONORM EN 1865-2 : 2015 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| ONORM EN ISO 18113-4 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009) |
| 93/68/EEC : 1993 AMD 2 1998 | COUNCIL DIRECTIVE 93/68/EEC OF 22.7.93 AMENDING DIRECTIVES 87/404/EEC, 88/378/EEC, 89/106/EEC, 89/336/EEC, 89/392/EEC, 89/686/EEC, 90/384/EEC, 90/385/EEC, 90/396/EEC, 91/263/EEC, 92/42/EEC AND 73/23/EEC |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| ISO 15198:2004 | Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
| AS 3954:2019 | Motor vehicle driver controls - Adaptive systems for people with disabilities |
| ISO 18153:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 19001:2013 | In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 17511:2003 | In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| IEC 60300-3-9:1995 | Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| ISO 9000-3:1997 | Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software |
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