IEC 60601-1:2005+AMD1:2012 CSV
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
05-09-2020
Superseded by
Published date
20-08-2012
Publisher
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IEC 60601-1:2005+A1:2012 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. This consolidated version consists of the third edition (2005) and its amendment 1 (2012). Therefore, there is no need to order the amendment in addition to this publication. This document includes the contents of the corrigenda 1 (2006), 2 (2007) and 3 (2022), the contents of the corrigendum to Amendment 1 (2014), as well as the interpretation sheets 1 (2008), 2 (2009), 3 (2013) and interpretation sheet to amendment 1 (2021).
IEC TR 62348:2012 provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012, and to trace requirements between the third edition and the amended second edition.
| Committee |
TC 62/SC 62A
|
| DevelopmentNote |
Stability Date: 2019. (10/2012) Supersedes IEC 60601-2-32. (11/2012)
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-0331-6
|
| Pages |
1660
|
| ProductNote |
CSV VERSION IS NOW AVAILABLE
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| OVE/ONORM EN 60601-1 : 2014 | Identical |
| UNE-EN 60601-1:2008 | Identical |
| NBN EN 60601-1 : 2007 AMD 2/COR 15 | Identical |
| NEN EN IEC 60601-1 : 2006 AMD 12 2014 | Identical |
| AS/NZS IEC 60601.1:2015 | Identical |
| PN EN 60601-1 : 2011 AC 1 2015 | Identical |
| VDE 0750-1 : 2013 | Identical |
| IS 13450 : Part 1 : 2018 | Identical |
| EN 60601-1:2006/A12:2014 | Identical |
| BIS IS 13450-1 : 2008 | Identical |
| GOST R IEC 60601-1 : 2010 | Identical |
| NF EN 60601-1 : 2007-01 | Identical |
| BS 5724-1(1989) : 1989 AMD 6715 | Similar to |
| I.S. HD 395.1:1995 | Identical |
| CSA C22.2 No. 601.1B : 1998(R2006) | Identical |
| HD 395.1 : S2 AMD 1 | Identical |
| UNE 20613-1:1983 | Identical |
| CEI 62-5 : 1ED 1980 | Identical |
| AAMI ES1 : 3ED 93 | Corresponds |
| DIN EN 60601-1 : 2010-05 | Identical |
| BS EN 60601-1 : 2006 | Identical |
| ONORM OVE EN 60601-1 : 1996 | Identical |
| DIN EN ISO 10524-4:2008-09 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| CSA C22.2 No. 80601-2-56 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
| DIN EN 60601-2-30 : 2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| NF EN ISO 80601-2-69 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| NF ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| BS 5724-2-45(2001) : 2001 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| BS EN 61331-1:2014 | Protective devices against diagnostic medical X-radiation Determination of attenuation properties of materials |
| BS EN 60601-2-51:2003 | Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| UNE-EN 80001-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| AAMI IEC TIR 60878 : 2003 | GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE |
| 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 |
| CEI EN 60601-1-11 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| CEI EN 62464-1 : 2007 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS |
| 17/30337954 DC : 0 | BS ISO 19211 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - FIRE-ACTIVATED OXYGEN SHUT-OFF DEVICES FOR USE DURING OXYGEN THERAPY |
| CSA Z8835.3 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| CSA CEI/IEC 1288.2 : 1998 | CARDIAC DEFIBRILLATORS - CARDIAC DEFIBRILLATORS-MONITORS - PART 2: MAINTENANCE |
| CSA C22.2 No. 601.2.33 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| BS ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for emissions of volatile organic compounds (VOCs) |
| 17/30321193 DC : 0 | BS ISO 23500-1 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 1. GENERAL REQUIREMENTS |
| 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 |
| BS ISO 17966:2016 | Assistive products for personal hygiene that support users. Requirements and test methods |
| PD IEC/TR 60601-4-2:2016 | Medical electrical equipment Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| CSA Z10524-3 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| PD IEC/TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| I.S. EN 13826:2003 | PEAK EXPIRATORY FLOW METERS |
| 15/30287229 DC : 0 | BS EN ISO 80369-1 - SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| IEEE 1708-2014 | IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices |
| 04/30084857 DC : DRAFT JUN 2004 | BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GAS SYSTEMS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| BS ISO 10341 : 1997 AMD 10606 | OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS |
| 09/30193293 DC : DRAFT MAR 2009 | BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| 03/311965 DC : DRAFT AUG 2003 | BS EN 61267 - MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS |
| BS ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Evaluation and testing within a risk management process |
| BS 5724-2.30(1993) : 1993 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR CAPNOMETERS FOR USE WITH HUMANS |
| DD ISO/TS 18835:2004 | Inhalational anaesthesia systems. Draw-over vaporizers and associated equipment |
| BS EN 60601-2-36:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
| I.S. EN ISO 22523:2006 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| 04/30115966 DC : DRAFT JUL 2004 | |
| 17/30357887 DC : 0 | BS ISO 20493 - TRADITIONAL CHINESE MEDICINE - INFRARED MOXIBUSTION-LIKE INSTRUMENT |
| 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 23328-2:2009 | Breathing system filters for anaesthetic and respiratory use Non-filtration aspects |
| I.S. EN ISO 8835-4:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| NF EN 60601-1-8 : 2007 AMD 11 2018 | 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 |
| 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 |
| NF EN 60731 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
| ANSI/AAMI CI86:2017 | COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING |
| BS EN 60601-2-26:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of electroencephalographs |
| 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 |
| BS EN ISO 80601-2-56:2017 | Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
| BS EN 62467-1:2015 | Medical electrical equipment. Dosimetric instruments as used in brachytherapy Instruments based on well-type ionization chambers |
| PREN ISO 80601-2-61 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| BS EN ISO 11073-10419:2016 | Health informatics. Personal health device communication Device specialization. Insulin pump |
| ANSI/AAMI/ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
| I.S. EN ISO 80601-2-61:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| ISO/TS 22595-1:2006 | Dentistry Plant area equipment Part 1: Suction systems |
| 09/30170496 DC : 0 | BS EN 60601-2-45 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES |
| BS 5724-2.32(1995) : 1995 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ASSOCIATED EQUIPMENT FOR X-RAY EQUIPMENT |
| 01/560793 DC : DRAFT FEB 2001 | IEC/DIS 60601-2-13 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC SYSTEMS |
| BS EN 60601-2-64:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
| 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) |
| 08/30170297 DC : DRAFT MAR 2008 | BS EN 62083 - MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| BS EN 60601-2-44 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009) |
| 09/30192356 DC : 0 | BS EN 12470-4:2000/A1 - CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| DIN ISO 14835-1:2005-12 | MECHANICAL VIBRATION AND SHOCK - COLD PROVOCATION TESTS FOR THE ASSESSMENT OF PERIPHERAL VASCULAR FUNCTION - PART 1: MEASUREMENT AND EVALUATION OF FINGER SKIN TEMPERATURE |
| 06/30160065 DC : 0 | BS EN ISO 11143 ED 2 - DENTAL EQUIPMENT - AMALGAM SEPARATORS |
| 16/30310674 DC : 0 | BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS |
| 17/30303094 DC : 0 | BS EN ISO 10524-3 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| 13/30268585 DC : 0 | BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT |
| 16/30342390 DC : 0 | BS EN 60601-2-63:2015/AMENDMENT 1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| 06/30112971 DC : DRAFT JULY 2006 | ISO/IEC 62366 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| BS EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies |
| 93/509316 DC : DRAFT DEC 1993 | ISO/DIS 10941 - OPTICS AND OPTICAL INSTRUMENTS - OPHTHALMIC INSTRUMENTS - OPTHALMIC LASER PHOTOCOAGULATORS |
| BS EN 62274:2005 | Medical electrical equipment. Safety of radiotherapy record and verify systems |
| 10/30201925 DC : 0 | BS ISO 23500 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES |
| ISO/IEEE 11073-10424:2016 | Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) |
| 13/30242951 DC : 0 | BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
| DIN EN ISO 8835-3:2011-02 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| 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 |
| BS ISO 10342 : 1997 AMD 10607 | OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS |
| BS 5724-2.27(1989) : 1989 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR OXYGEN ANALYZERS FOR MONITORING PATIENT BREATHING MIXTURES |
| I.S. EN ISO 18397:2016 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
| 07/30167441 DC : 0 | BS ISO 15752 - OPHTHALMIC INSTRUMENTS - END ILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| BS EN ISO 26782:2009 | Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans |
| ISO 8835-7:2011 | Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| 13/30245306 DC : 0 | BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS |
| BS EN 60601-1-12:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| DIN VDE 0750-222 : 1990 | MEDICAL ELECTRICAL EQUIPMENT; PARTICULAR REQUIREMENTS FOR THE SAFETY OF THERAPEUTIC X-RAY GENERATORS |
| AAMI/IEC TIR61289:2011 | HIGH FREQUENCY SURGICAL EQUIPMENT - OPERATION AND MAINTENANCE |
| BS EN 60601-2-30:2000 | Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| AAMI EC71 : 2001 : R2013 | STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| 17/30362279 DC : 0 | BS EN 61223-3-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-6: ACCEPTANCE AND CONSTANCY TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC TOMOSYNTHESIS MODE OF OPERATION OF MAMMOGRAPHIC X-RAY EQUIPMENT |
| 12/30262710 DC : 0 | BS EN ISO 10341 - OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS |
| UNE-EN 60645-6:2010 | Electroacoustics - Audiometric equipment -- Part 6: Instruments for the measurement of otoacoustic emissions |
| 10/30205392 DC : 0 | BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| 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 |
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| 15/30312454 DC : 0 | BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
| BS EN 60601-2-13:2006 | Medical electrical equipment Particular requirements for the safety and essential performance of anaesthetic systems |
| BS EN 61910-1:2014 | Medical electrical equipment. Radiation dose documentation Radiation dose structured reports for radiography and radioscopy |
| 03/311987 DC : DRAFT AUG 2003 | BS EN 60601-2-27 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| 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 |
| AAMI ID26:2004 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| 06/30107360 DC : 0 | IEC 60601-1-3 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| BS ISO 10936-1:2017 | Optics and photonics. Operation microscopes Requirements and test methods |
| I.S. EN IEC 62667:2018 | MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
| NF EN 60601 2-36 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| BIS IS/ISO 10524-3 : 2005 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| ASTM F 1464 : 1993 : R1999 | Standard Specification for Oxygen Concentrators for Domiciliary Use |
| 04/30107378 DC : DRAFT JUL 2004 | EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| NF EN ISO 15752 : 2010 | OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| BS EN 62353:2014 | Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment |
| BIS IS/ISO 10079-3 : 1999 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE |
| BS EN 62083:2009 | Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems |
| IEC 80601-2-49:2018 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| AAMI ID26 : 2004 : R2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| 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 |
| AAMI TIR59:2017 | INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS |
| NF EN 61910-1 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY |
| 07/30152116 DC : 0 | BS EN 62467-1 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS |
| BS EN 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment |
| BS EN 60601-2-40:1998 | Medical electrical equipment. Particular requirements for safety Specification for electromyographs and evoked response equipment |
| CSA Z10079.1 : 2003 : R2013 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT - SAFETY REQUIREMENTS |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| CSA ISO 14971 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA Z10535 : 2003 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| 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 |
| DIN EN ISO 18397:2016-09 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
| AAMI EC38 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS |
| CSA Z9919 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| IEC TR 60977:2008 | Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics |
| 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) |
| EN ISO 19980:2012 | Ophthalmic instruments - Corneal topographers (ISO 19980:2012) |
| ASTM F 1415 : 1992 : R2000 | Standard Specification for Pulse Oximeters (Withdrawn 2005) |
| BIS IS 13450-1-3 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - SECTION 3: COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
| ISO 13091-1:2001 | Mechanical vibration Vibrotactile perception thresholds for the assessment of nerve dysfunction Part 1: Methods of measurement at the fingertips |
| AAMI HE75 : 2009(R2013) | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| I.S. EN 60598-2-25:1996 | LUMINAIRES - PART 2: PARTICULAR REQUIREMENTS - SECTION 25: LUMINAIRES FOR USE IN CLINICAL AREAS OF HOSPITALS AND HEALTH CARE BUILDINGS |
| 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) |
| 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) |
| I.S. EN 60645-7:2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSES |
| 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) |
| BS EN ISO 11073-10424:2016 | Health informatics. Personal health device communication Device specialization. Sleep apnoea breathing therapy equipment (SABTE) |
| I.S. EN 61331-1:2014 | PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS |
| CSA ISO 9703-2 : 0 | ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 2: AUDITORY ALARM SIGNALS |
| I.S. EN ISO 26782:2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
| EN ISO 22374:2005 | Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips (ISO 22374:2005) |
| BS EN 60335-2-69:2012 | Household and similar electrical appliances. Safety Particular requirements for wet and dry vacuum cleaners, including power brush for commercial use |
| CSA C22.2 No. 60601.1.1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| 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) |
| I.S. EN 60601-1-6:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| 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) |
| 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 |
| 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 |
| I.S. EN ISO 10524-4:2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS |
| BS EN 62464-1:2007 | Magnetic resonance equipment for medical imaging Determination of essential image quality parameters |
| I.S. EN 60601-2-24:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| I.S. EN 60601-2-66:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
| I.S. ISO 7396:1989 | NON-FLAMMABLE MEDICAL GAS PIPELINE SYSTEMS |
| CSA C22.2 No. 60601.1.1 : 2002 : R2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| AAMI AT6 : 2013 | AUTOLOGOUS TRANSFUSION DEVICES |
| BS EN 60601-1-6 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| 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 |
| CSA ISO TR 13154 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH |
| ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
| BS EN 13976-1:2011 | Rescue systems. Transportation of incubators Interface conditions |
| UNI CEI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| ISO 16571:2014 | Systems for evacuation of plume generated by medical devices |
| CSA ISO 5362 : 2014 | ANAESTHETIC RESERVOIR BAGS |
| I.S. EN 60601-2-64:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| UNI EN ISO 7494-1 : 2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 22665 : 2013 | OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE |
| AAMI CN6 : 2015 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS |
| 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 ISO 22665:2012 | OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE (ISO 22665:2012) |
| BS EN ISO 11073-10427:2018 | Health informatics. Personal health device communication Device specialization. Power status monitor of personal health devices devices |
| I.S. EN 61391-2:2010 | ULTRASONICS - PULSE-ECHO SCANNERS - PART 2: MEASUREMENT OF MAXIMUM DEPTH OF PENETRATION AND LOCAL DYNAMIC RANGE |
| IEC TR 60930:2008 | Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems |
| ASTM F 1101 : 1990 : R1996 | Standard Specification for Ventilators Intended for Use During Anesthesia |
| AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| 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) |
| DIN EN 60601-2-40 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| NF EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| NF EN ISO 26782 : 2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
| CEI EN 62467-1 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS |
| BS EN 60601-2-54:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| NF EN 60601 2-6 : 2015 AMD 1 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT |
| CSA C22.2 No. 60601.2.51 : 2004 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
| UNI CEI EN 980 : 2009 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| CSA Z23500 : 2016 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES |
| ASTM F 1452 : 2001 | Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors |
| ISO 10524-3:2005 | Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves |
| ASTM F 1464 : 1993 : R2005 | Standard Specification for Oxygen Concentrators for Domiciliary Use (Withdrawn 2014) |
| I.S. EN 61674:2013 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING (IEC 61674:2012 (EQV)) |
| 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 |
| IEC 60417-1:2002 | Graphical symbols for use on equipment - Part 1: Overview and application |
| 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 |
| IEC 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| 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 10944:2010-01 | Ophthalmic instruments - Synoptophores (ISO 10944:2009) |
| DIN EN ISO 10342:2010-11 | Ophthalmic instruments - Eye refractometers (ISO 10342:2010) |
| DIN EN ISO 7376:2010-01 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| DIN EN ISO 11143:2008-10 | DENTISTRY - AMALGAM SEPARATORS |
| BS EN ISO 10650-1:2005 | Dentistry. Powered polymerization activators Quartz tungsten halogen lamps |
| IEC 60601-2-9:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
| 15/30319022 DC : 0 | BS EN 60990 ED 3.0 - METHODS OF MEASUREMENT OF TOUCH CURRENT AND PROTECTIVE CONDUCTOR CURRENT |
| UNE-EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| UNE-EN 12312-14:2015 | Aircraft ground support equipment - Specific requirements - Part 14: Disabled/incapacitated passenger boarding vehicles |
| ISO 10524-4:2008 | Pressure regulators for use with medical gases — Part 4: Low-pressure regulators |
| BS EN 13718-1:2014 | Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
| BS EN ISO 7494:1998 | Dental units |
| 09/30162904 DC : 0 | BS EN 61204-3 - LOW-VOLTAGE POWER SUPPLIES, D.C. OUTPUT - PART 3: ELECTROMAGNETIC COMPATIBILITY (EMC) |
| BS EN ISO 8359 : 2009 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS |
| ISO 8835-5:2004 | Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
| BS EN ISO 11498:2000 | Dental handpieces. Dental low-voltage electric motors |
| UNE-EN 61331-1:2015 | Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials |
| UNE-EN ISO 11252:2013 | Lasers and laser-related equipment - Laser device - Minimum requirements for documentation (ISO 11252:2013) |
| UNE-EN 61331-2:2015 | Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates |
| ISO 13958:2014 | Concentrates for haemodialysis and related therapies |
| UNE-EN 61140:2017 | Protection against electric shock - Common aspects for installation and equipment |
| UNE-EN 60335-2-69:2013 | Household and similar electrical appliances - Safety - Part 2-69: Particular requirements for wet and dry vacuum cleaners, including power brush for commercial use |
| ISO/IEEE 11073-00103:2015 | Health informatics — Personal health device communication — Part 00103: Overview |
| 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 ISO 7176-14:2008 | Wheelchairs Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods |
| ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
| BS EN ISO 11904-1:2002 | Acoustics. Determination of sound immission from sound sources placed close to the ear. Technique using a microphone in a real ear (MIRE technique) |
| BS EN 12342 : 1998 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| BS EN ISO 7376 : 2009-08 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| BS EN ISO 10343:2014 | Ophthalmic instruments. Ophthalmometers |
| PD IEC/TR 62354:2014 | General testing procedures for medical electrical equipment |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
| ISO 22665:2012 | Ophthalmic optics and instruments - Instruments to measure axial distances in the eye |
| BS EN ISO 16201:2006 | Technical aids for disabled persons. Environmental control systems for daily living |
| DIN EN 12342:1998-09 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| I.S. EN 61223-2-6:2007 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| I.S. EN ISO 10535:2006 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| DIN EN 12342:2010-01 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| DIN EN 12470-3:2000-04 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| I.S. EN ISO 18777:2009 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| DIN EN ISO 10524-2:2006-07 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| I.S. EN ISO 10939:2017 | OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017) |
| CEN/TS 14507-1:2003 | Inhalational nitric oxide systems - Part 1: Delivery systems |
| DIN EN ISO 23328-2:2009-07 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| EN 60645-7:2010 | Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses |
| EN ISO 23328-2:2009 | Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002) |
| BS 4743:1979 | Specification for safety requirements for electronic measuring apparatus |
| NF EN 60522 : 2003 | DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES |
| EN 61168:1994 | Radiotherapy simulators - Functional performance characteristics |
| NF 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 |
| EN 61027 : 1993 | SPECIFICATION FOR INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE |
| EN 60601-2-26:2015 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| EN ISO 10942:2006 | Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2006) |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| 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 |
| IEC 61204-3:2016 RLV | Low-voltage switch mode power supplies - Part 3: Electromagnetic compatibility (EMC) |
| EN 60601-2-35:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use |
| EN 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| EN 62494-1:2008 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
| EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
| 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 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 61689:2013 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
| EN 60627:2015 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| AAMI HE48 : 1993 | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
| NF EN 61223-3-5 : 2005 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| EN 61391-2:2010 | Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| DIN EN ISO 19980:2012-07 | Ophthalmic instruments - Corneal topographers (ISO 19980:2012) |
| EN ISO 9680:2014 | Dentistry - Operating lights (ISO 9680:2014) |
| EN 60601-2-51:2003 | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| EN 60601-3-1:1996 | Medical electrical equipment - Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment |
| EN 60645-5:2005 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
| EN ISO 22523:2006 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| EN 61558-2-16:2009/A1:2013 | SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND SIMILAR PRODUCTS FOR SUPPLY VOLTAGES UP TO 1 100 V - PART 2-16: PARTICULAR REQUIREMENTS AND TESTS FOR SWITCH MODE POWER SUPPLY UNITS AND TRANSFORMERS FOR SWITCH MODE POWER SUPPLY UNITS (IEC 61558-2-16:2009/A1:2013) |
| EN 61331-1:2014 | Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials |
| EN 61223-3-3:1996 | Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA) |
| EN 62467-1:2015 | Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers |
| EN 61217:2012 | Radiotherapy equipment - Coordinates, movements and scales |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| EN 12470-3:2000+A1:2009 | Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
| NF EN 60601-2-26 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| 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) |
| EN 61953 : 1998 | DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF MAMMOGRAPHIC ANTI-SCATTER GRIDS |
| EN 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| 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 61669:2016 | Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids |
| UNI EN ISO 19980 : 2012 | OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS |
| I.S. EN ISO 16201:2006 | TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING |
| NF EN ISO 16201 : 2007 | TECHNICAL AIDS FOR PERSONS WITH DISABILITY - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING |
| ONORM EN ISO 11608-4 : 2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| NF EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| AAMI TIR26 : 2000 | VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS |
| XP CEN/TS 14507-2 : 2003 XP | INHALATION NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
| BS EN ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| CAN/CSA-ISO 16571:16 | SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
| DIN EN 60580:2001-12 | Medical electrical equipment - Dose area product meters (IEC 60580:2000); German version EN 60580:2000 |
| ONORM EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| CSA Z10524-2 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| 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 |
| BS EN 60417-1:1999 | Graphical symbols for use on equipment Overview and application |
| I.S. EN ISO 11073-00103:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
| 09/30173644 DC : 0 | BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN ISO 8359:2009 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS (ISO 8359:1996) |
| 07/30157348 DC : 0 | BS ISO 26782 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE ASSESSMENT OF PULMONARY FUNCTION IN HUMANS |
| I.S. EN 82304-1:2017 | HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| ISO/IEEE 11073-10425:2016 | Health informatics Personal health device communication Part 10425: Device specialization Continuous glucose monitor (CGM) |
| BS ISO 7494 : 96 AMD 9861 | DENTAL UNITS |
| BS EN ISO 5359 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
| BS EN 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| CEI EN 60601-2-24 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| 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 |
| 06/30136646 DC : DRAFT FEB 2006 | ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
| DIN EN ISO 15752:2010-05 | Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010) |
| CEI EN 61391-2 : 2011 | ULTRASONICS - PULSE-ECHO SCANNERS - PART 2: MEASUREMENT OF MAXIMUM DEPTH OF PENETRATION AND LOCAL DYNAMIC RANGE |
| BS 5724-1.4(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| I.S. EN ISO 7785-1:1999 | DENTAL HANDPIECES - PART 1: HIGH-SPEED AIR TURBINE HANDPIECES |
| BS EN 60601-2-38:1997 | Medical electrical equipment. Particular requirements for safety Particular requirements for the safety of electrically operated hospital beds |
| BS ISO 14835-2:2005 | Mechanical vibration and shock. Cold provocation tests for the assessment of peripheral vascular function Measurement and evaluation of finger systolic blood pressure |
| I.S. EN ISO 11498:1999 | DENTAL HANDPIECES - DENTAL LOW-VOLTAGE ELECTRICAL MOTORS |
| 16/30216785 DC : 0 | BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
| 11/30243761 DC : 0 | BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
| 15/30322732 DC : 0 | BS EN 60601-2-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-10: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NERVE AND MUSCLE STIMULATORS - PROPOSED HORIZONTAL STANDARD |
| CEI EN 60731 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
| OIML R 115 : 1995 | CLINICAL ELECTRICAL THERMOMETERS WITH MAXIMUM DEVICE |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 04/30115525 DC : DRAFT JUN 2004 | PREN 12312-14 - AIRCRAFT GROUND SUPPORT EQUIPMENT - PART 14: DISABLED INCAPACITATED PASSENGER BOARDING EQUIPMENT |
| 11/30206856 DC : 0 | BS EN 60601-1-8:2007/A1 - 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 |
| UNI EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| BS EN 60645-6:2010 | Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions |
| 14/30284310 DC : 0 | BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS |
| DD CEN/TS 14507-1:2003 | Inhalational nitric oxide systems Delivery systems |
| 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) |
| 16/30329598 DC : 0 | BS ISO 11195 - GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS |
| BS ISO 10651-5:2006 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators |
| UNI EN ISO 7376 : 2009-10 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| 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 |
| BS EN 61223-3-4:2000 | Evaluation and routine testing in medical imaging departments Acceptance tests |
| BS EN ISO 23500:2015 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
| 17/30357644 DC : 0 | BS EN ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF INTERMITTENT AUTOMATED MEASUREMENT TYPE |
| UNE-EN ISO 80369-1:2011 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| 14/30313972 DC : 0 | BS EN 60645-1 ED.4.0 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY |
| 14/30287753 DC : 0 | BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
| BS ISO 14835-1:2016 | Mechanical vibration and shock. Cold provocation tests for the assessment of peripheral vascular function Measurement and evaluation of finger skin temperature |
| 03/114562 DC : DRAFT SEP 2003 | BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| 11/30239319 DC : 0 | BS EN ISO 22665 - OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE |
| BS 5724-2.31(1995) : 1995 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| 11/30233851 DC : 0 | BS EN ISO 10943 - OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| AAMI TIR66 : 2017 | GUIDANCE FOR THE CREATION OF PHYSIOLOGIC DATA AND WAVEFORM DATABASES TO DEMONSTRATE REASONABLE ASSURANCE OF THE SAFETY AND EFFECTIVENESS OF ALARM SYSTEM ALGORITHMS |
| 03/111613 DC : DRAFT AUG 2003 | BS EN ISO 9919 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| 15/30288418 DC : 0 | BS EN ISO 80369-2 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 2: CONNECTORS FOR BREATHING SYSTEMS AND DRIVING GASES APPLICATIONS |
| UNE-EN 60601-2-66:2016 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument 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 |
| DD ENV 1064:1994 | Medical informatics. Standards communications protocol. Computer-assisted electrocardiography |
| DIN EN ISO 22665:2013-04 | OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE (ISO 22665:2012) |
| UNI EN ISO 81060-2 : 2014 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
| BS EN 60627:2015 | Diagnostic X-ray imaging equipment. Characteristics of general purpose and mammographic anti-scatter grids |
| ANSI Z80.23 : 2008 | OPHTHALMICS - CORNEAL TOPOGRAPHY SYSTEMS - STANDARD TERMINOLOGY, REQUIREMENTS |
| DIN EN ISO 15002:2008-11 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| 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 |
| UNI ISO 14835-2 : 2010 | MECHANICAL VIBRATION AND SHOCK - COLD PROVOCATION TESTS FOR THE ASSESSMENT OF PERIPHERAL VASCULAR FUNCTION - PART 2: MEASUREMENT AND EVALUATION OF FINGER SYSTOLIC BLOOD PRESSURE |
| 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 |
| 15/30280904 DC : 0 | BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
| 12/30259708 DC : 0 | BS EN ISO 5356-1 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO/DIS 5356-1:2012) |
| 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 |
| DIN EN ISO 22374:2005-12 | DENTISTRY - DENTAL HANDPIECES - ELECTRICAL-POWERED SCALERS AND SCALER TIPS |
| 04/30112949 DC : DRAFT APR 2004 | IEC 60825-8 ED.2 - SAFETY OF LASER PRODUCTS - PART 8: GUIDELINES FOR THE USE OF MEDICAL LASER EQUIPMENT |
| DIN EN ISO 13958:2016-03 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
| IEC TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 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) |
| BS EN 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| BS 5724-2.40(1998) : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-40: ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| 04/30110485 DC : DRAFT MARCH 2004 | ISO 14835-2 - MECHANICAL VIBRATION AND SHOCK - COLD PROVOCATION TESTS FOR THE ASSESSMENT OF PERIPHERAL VASCULAR FUNCTION - PART 2 - MEASUREMENT AND EVALUATION OF FINGER SYSTOLIC BLOOD PRESSURE |
| 02/206610 DC : DRAFT MAY 2002 | IEC 61010-2-040. ED.1 - 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 |
| BS EN 60601-2-66:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| PD ISO/TR 13154:2017 | Medical electrical equipment. Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph |
| BS 5724-2.38(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| 12/30271196 DC : 0 | BS EN 60601-1-10:2007/A1 - 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 |
| 03/302031 DC : DRAFT FEB 2003 | BS EN 60789 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS AND TEST CONDITIONS OF RADIONUCLIDE IMAGING DEVICES - ANGER TYPE GAMMA CAMERAS |
| BS EN 45502-2-3:2010 | Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems |
| 13/30270468 DC : 0 | BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| 06/30160368 DC : 0 | BS EN 80100 - BASIC SAFETY AND ESSENTIAL PERFORMANCE REQUIREMENTS OF CLINICAL THERMOMETER FOR BODY TEMPERATURE MEASUREMENT |
| CSA Z1500:2012 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| BS 5724-2.202(1997) : 1997 + A2 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| CEI EN 61689 : 2013 | ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ |
| PREN ISO 5356-1 : DRAFT 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO/DIS 5356-1:2012) |
| PD IEC/TR 60601-4-4:2017 | Medical electrical equipment Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| BS 5724-2.24(1989) : 1989 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR HUMIDIFIERS |
| 05/30114976 DC : DRAFT FEB 2005 | ISO 10943 - OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES |
| ASTM F 882 : 1984 : R2002 | Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011) |
| PD IEC/TR 62296:2009 | Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements |
| CEI EN 62274 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| 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 |
| BS EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications |
| IEC 80601-2-71:2015 | Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
| I.S. EN ISO 80601-2-56:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017) |
| 03/111581 DC : DRAFT JULY 2003 | BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| 06/30137313 DC : 0 | ISO/IEC 81060-1 - NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR MECHANICAL TYPE |
| 09/30181956 DC : DRAFT MAY 2009 | BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| BS EN 61689:2013 | Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
| BS EN 61675-2:2015 | Radionuclide imaging devices. Characteristics and conditions Gamma cameras for planar, wholebody, and SPECT imaging |
| CSA Z10535 : 2003 : R2014 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| CEI EN 60335-2-69 : 2014 | HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-69: PARTICULAR REQUIREMENTS FOR WET AND DRY VACUUM CLEANERS, INCLUDING POWER BRUSH, FOR COMMERCIAL USE |
| CSA ISO 81060-2 : 2014 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
| CSA Z8836 :2011 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| 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) |
| CEI EN 60645-1 : 2016 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AUDIOMETRY |
| GOST R IEC 60627 : 2005 | DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS |
| NF EN 60601-1-11 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| CSA Z21647 : 2007 : R2012 : FR | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| DIN 6855-11:2016-08 | CONSTANCY TESTING OF NUCLEAR MEDICINE INSTRUMENTS - PART 11: RADIONUCLIDE CALIBRATORS (IEC/TR 61948-4:2006, MODIFIED) |
| AAMI ISO 13958 : 2009 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
| ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| 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 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| IEC TS 60479-1:2005+AMD1:2016 CSV | Effects of current on human beings and livestock - Part 1: Generalaspects |
| ISO 11197:2016 | Medical supply units |
| ISO 7176-14:2008 | Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters Requirements and test methods |
| NF EN 60601-1-1 : 2001 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| UNE-EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| I.S. EN 60601-2-26:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| ISO 14835-2:2005 | Mechanical vibration and shock — Cold provocation tests for the assessment of peripheral vascular function — Part 2: Measurement and evaluation of finger systolic blood pressure |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| CSA C22.2 No. 60601-2-64 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| UNE-EN 60645-7:2010 | Electroacoustics - Audiometric equipment -- Part 7: Instruments for the measurement of auditory brainstem responses |
| AAMI ISO 10079-1 : 1999 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT - SAFETY REQUIREMENTS |
| I.S. EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| I.S. EN 61689:2013 | ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ (IEC 61689:2013 (EQV)) |
| BS EN ISO 10637:2000 | Dental equipment. High and medium volume suction systems |
| AAMI ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| I.S. EN 61558-2-16:2009 | SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND SIMILAR PRODUCTS FOR SUPPLY VOLTAGES UP TO 1100 V - PART 2-16: PARTICULAR REQUIREMENTS AND TESTS FOR SWITCH MODE POWER SUPPLY UNITS AND TRANSFORMERS FOR SWITCH MODE POWER SUPPLY UNITS |
| I.S. EN ISO 14457:2017 | DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017) |
| 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) |
| I.S. EN 62353:2014 | MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
| CEI EN 60601-2-9 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| UNI EN ISO 80601-2-61 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| UNE-EN ISO 7494-1:2012 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| I.S. EN 60645-6:2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| I.S. EN 16812:2016 | TEXTILES AND TEXTILE PRODUCTS - ELECTRICALLY CONDUCTIVE TEXTILES - DETERMINATION OF THE LINEAR ELECTRICAL RESISTANCE OF CONDUCTIVE TRACKS |
| BS EN 60601-2-10:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| I.S. ISO 5369:1987 | BREATHING MACHINES FOR MEDICAL USE - LUNG VENTILATORS |
| 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) |
| I.S. EN 60601-2-36:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| 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) |
| BIS IS/ISO 14708-1 : 2000 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process |
| UNI EN ISO 23328-2 : 2009 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| CEI UNI EN ISO 80369-1 : 2011 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| CEI EN 60627 : 2016 | DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS |
| CSA IEC 62366-1 : 2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| CSA ISO 11195 : 2014 | GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS |
| NF EN ISO 80601-2-13 : 2013 AMD 1 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
| NF EN 60601 2-13 : 2007 AMD 1 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| BS EN 41003:2009 | Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system |
| CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| I.S. EN 60601-2-54:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| BS EN ISO 5367:2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
| UNE-EN ISO 14457:2013 | Dentistry - Handpieces and motors (ISO 14457:2012) |
| UNE-EN ISO 5367:2015 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| IEC TR 61948-3:2018 | Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| CSA C22.2 No. 601.1.1 : 2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| BS EN ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications |
| CSA C22.2 No. 601.2.29 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY SIMULATORS |
| CSA C22.2 No. 601.2.31 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| 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 |
| ANSI Z80.37 : 2017 | OPHTHALMICS - SLIT-LAMP MICROSCOPES |
| NF EN 60613 : 2010 | ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| OIML R 114 : 1995 | CLINICAL ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| UNE-EN ISO 13958:2016 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
| UNI EN ISO 15752 : 2010 | OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| CSA C22.2 No. 60601.2.36 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| NF EN 60601-1-12 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| 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 |
| UNI EN ISO 10524-3 : 2013 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| 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 61204-7:2006 | LOW VOLTAGE POWER SUPPLIES, D.C. OUTPUT - PART 7: SAFETY REQUIREMENTS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ASTM F 1415 : 1992 | Standard Specification for Pulse Oximeters |
| BS EN ISO 80601-2-61:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| CEI UNI EN ISO 14971 : 2013 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| NF EN ISO 7376 : NOV 2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
| ISO 11073-91064:2009 | Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography |
| IEC 60364-7-710:2002 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations |
| IEC TR 62296:2009 | Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements |
| IEC 80601-2-30:2018 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| I.S. EN 62494-1:2008 | MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY |
| IEC TR 61258:2008 | Guidelines for the development and use of medical electrical equipment educational materials |
| ANSI/AAMI/IEC TIR62354:2015 | GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT |
| I.S. EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| 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 |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| I.S. EN ISO 14971:2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
| 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 |
| IEC 60645-1:2017 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
| DIN EN 1639:2010-02 | Dentistry - Medical devices for dentistry - Instruments |
| DIN EN ISO 6875:2011-10 | DENTISTRY - PATIENT CHAIR |
| DIN EN ISO 8835-4:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
| DIN EN ISO 17510-2:2009-07 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| DIN EN ISO 8835-2:2009-08 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| DIN EN 1640:2010-02 | Dentistry - Medical devices for dentistry - Equipment |
| NF EN 13718-2 : 2017 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| DIN EN ISO 18778:2009-08 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| DIN EN ISO 18777:2009-07 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| BS EN ISO 10535:2006 | Hoists for the transfer of disabled persons. Requirements and test methods |
| UNE-EN ISO 21969:2010 | High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| BS EN 60789:2005 | Medical electrical equipment. Characteristics and test conditions of radionuclide imaging devices. Anger type gamma cameras |
| 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) |
| IEC 60601-2-63:2012+AMD1:2017 CSV | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| BS EN ISO 13294:1997 | Dental handpieces. Dental air-motors |
| BS EN ISO 12865:2006 | Ophthalmic instruments. Retinoscopes |
| BS EN 1640:2009 | Dentistry. Medical devices for dentistry. Equipment |
| 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 12866 : 1999 | OPHTHALMIC INSTRUMENTS - PERIMETERS |
| 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 1064:2005 | Health informatics. Standard communication protocol. Computer-assisted electrocardiography |
| BS EN ISO 8835-2:2009 | Inhalational anaesthesia systems Anaesthetic breathing systems (ISO 8835-2:2007) |
| 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/IEEE 11073-10441:2015 | Health informatics — Personal health device communication — Part 10441: Device specialization — Cardiovascular fitness and activity monitor |
| ISO 11143:2008 | Dentistry Amalgam separators |
| IEC 60601-2-10:2012+AMD1:2016 CSV | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators |
| BS EN ISO 9360-1:2009 | Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans HMEs for use with minimal tidal volumes of 250 ml |
| DIN EN ISO 9680:2015-02 | Dentistry - Operating lights (ISO 9680:2014) |
| UNE-EN ISO 10940:2010 | Ophthalmic instruments - Fundus cameras (ISO 10940:2009) |
| UNE-EN 61331-3:2015 | Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields |
| BS EN 12470-3 : 2000 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| IEC 61223-3-3:1996 | Evaluation and routine testing in medical imaging departments -Part 3-3: Acceptance tests - Imaging performance of X-ray equipmentfor digital subtraction angiography (DSA) |
| DIN EN ISO 11608-4:2016-03 (Draft) | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| DIN EN ISO 10650-2:2007-11 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS |
| EN 13819-2:2002 | Hearing protectors - Testing - Part 2: Acoustic test methods |
| I.S. EN ISO 10942:2006 | OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES |
| I.S. EN 12184:2014 | ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 6875:2011 | DENTISTRY - PATIENT CHAIR |
| I.S. EN ISO 10343:2014 | OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014) |
| 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 12312-14:2014 | AIRCRAFT GROUND SUPPORT EQUIPMENT - SPECIFIC REQUIREMENTS - PART 14: DISABLED/INCAPACITATED PASSENGER BOARDING VEHICLES |
| I.S. EN ISO 8612:2009 | OPHTHALMIC INSTRUMENTS - TONOMETERS |
| I.S. EN ISO 18778:2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| DIN EN 12470-4:2001-02 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| I.S. EN ISO 10940:2009 | OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS |
| I.S. EN ISO 12865:2006 | OPHTHALMIC INSTRUMENTS - RETINOSCOPES |
| I.S. EN ISO 11143:2008 | DENTISTRY - AMALGAM SEPARATORS |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| I.S. EN 13819-2:2002 | HEARING PROTECTORS - TESTING - PART 2: ACOUSTIC TEST METHODS |
| I.S. EN 12182:2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 7494:1998 | DENTAL UNITS |
| I.S. EN ISO 10943:2011 | OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES |
| I.S. EN ISO 17510-2:2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| I.S. EN ISO 11252:2013 | LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION (ISO 11252:2013) |
| I.S. EN ISO 9703-3:1999 | ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 3: GUIDANCE ON APPLICATION OF ALARMS |
| DIN EN ISO 10650-1:2006-01 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 1: QUARTZ TUNGSTEN HALOGEN LAMPS |
| I.S. EN ISO 15001:2011 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN (ISO 15001:2010) |
| I.S. EN 61217:2012 | RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV)) |
| I.S. EN 61267:2006 | MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS |
| I.S. EN 60601-2-17:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| 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 10342:2010 | OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS |
| I.S. EN ISO 8185:2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| I.S. EN ISO 10944:2009 | OPHTHALMIC INSTRUMENTS - SYNOPTOPHORES |
| I.S. EN ISO 10341:2012 | OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS (ISO 10341:2012) |
| 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 9360-1:2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML |
| I.S. EN 60601-1-3:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| EN 60601-1-3 : 2008 AMD 11 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013) |
| DIN EN ISO 10343:1999-07 | OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014) |
| I.S. EN ISO 15004-1:2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| 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 21969:2009 | HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS |
| I.S. EN 60601-2-33:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| DIN EN 957-6:2001-11 | STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS |
| 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 18779:2005 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| I.S. EN 957-6:2010 | STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS |
| EN ISO 15004-1:2009 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
| 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 ISO 8359:2009-08 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS |
| I.S. EN ISO 19980:2012 | OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS (ISO 19980:2012) |
| UNI EN ISO 15001 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN |
| 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 |
| OVE/ONORM EN 61223-3-5 : 2005 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| NEMA XR 9-1984 (R1994, R2000) | POWER SUPPLY GUIDELINES FOR X-RAY MACHINES |
| VDE 0750-2-32 : 1995 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT |
| NEMA XR 14-1990 (R1995, R2000) | RECOMMENDED PRACTICES FOR LOAD-BEARING MECHANICAL ASSEMBLIES USED IN DIAGNOSTIC IMAGING |
| NF EN ISO 10942 : 2007 | OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES |
| VDE 0750-2-64 : 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| NEMA/MITA 1:2015 | Good Refurbishment Practices for Medical Imaging Equipment |
| NF EN ISO 18778 : 2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| BS 2011-2.1R:1990 | Environmental testing. Tests Test R and guidance. Water |
| NEMA RT 1:2014 | Gating Interface |
| DIN EN 60601-2-64 : 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| DIN EN 60601-2-35 : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE |
| CSA Z10524-2 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS |
| ISO 80601-2-61:2017 | Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| UNI EN ISO 81060-1 : 2012 | NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
| BS EN ISO 10650:2015 | Dentistry. Powered polymerization activators |
| BS EN 61674:2013 | Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| CSA Z10524-1 : 2012 : R2017 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
| 13/30260084 DC : 0 | BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS |
| NF EN 60601-2-64 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
| NF EN ISO 8835-3 : 2009 AMD 1 2011 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| 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 |
| ANSI/AAMI/IEC 80001-1:2010 | APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES |
| DIN EN ISO 81060-2:2014-10 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVASTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013) |
| 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 |
| 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 |
| 11/30215841 DC : 0 | BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS |
| 14/30296572 DC : 0 | BS EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| AAMI ISO 81060-2 : 2013 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
| I.S. EN ISO 9919:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| 05/30098700 DC : DRAFT JUL 2005 | ISO 9680 - DENTAL OPERATING LIGHT |
| 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 |
| BS EN 61331-2:2014 | Protective devices against diagnostic medical X-radiation Translucent protective plates |
| BS EN 80001-1:2011 | Application of risk management for IT-networks incorporating medical devices Roles, responsibilities and activities |
| ANSI/AAMI NS4:2013(R2017) | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS |
| 17/30323658 DC : 0 | BS EN ISO 7488 - MIXING MACHINES FOR DENTAL AMALGAM |
| 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 |
| CSA C22.2 No. 60601.2.9 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| I.S. EN ISO 8835-2:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| BS EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications Connectors for intravascular or hypodermic applications |
| BS EN 82304-1:2017 | Health Software General requirements for product safety |
| CSA C22.2 No. 601.2.21 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT RADIANT WARMERS |
| BS ISO 28057 : 2014 | DOSIMETRY WITH SOLID THERMOLUMINESCENCE DETECTORS FOR PHOTON AND ELECTRON RADIATIONS IN RADIOTHERAPY |
| BS EN ISO 15752:2010 | Ophthalmic instruments. Endoilluminators. Fundamental requirements and test methods for optical radiation safety |
| 13/30268519 DC : 0 | BS ISO 80601-2-13:2011/AMD 1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
| AAMI ISO 10651-5 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| BS 7698-12:1998 | Reciprocating internal combustion engine driven alternating current generating sets Emergency power supply to safety devices |
| UNI EN ISO 11073-30400 : 2013 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET |
| BS EN ISO 22665:2012 | Ophthalmic optics and instruments. Instruments to measure axial distances in the eye |
| BS EN ISO 81060-1:2012 | Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type |
| NF ISO 13091-1 : 2003 AMD 1 2010 | MECHANICAL VIBRATION - VIBROTACTILE PERCEPTION THRESHOLDS FOR THE ASSESSMENT OF NERVE DYSFUNCTION - PART 1: METHOD OF MEASUREMENT AT THE FINGERTIPS |
| CSA CEI/IEC 1289.1 : 1998 | HIGH-FREQUENCY SURGICAL EQUIPMENT - PART 1: OPERATION |
| XP CEN/TS 14507-1 : 2003 XP | INHALATION NITRIC OXIDE SYSTEMS - PART 1 : DELIVERY SYSTEMS |
| 10/30206860 DC : 0 | BS EN 61217 - RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES |
| 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 |
| BS EN ISO 80601-2-69:2014 | Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| UNE-EN 16812:2016 | Textiles and textile products - Electrically conductive textiles - Determination of the linear electrical resistance of conductive tracks |
| BS EN ISO 10524-1:2006 | Pressure regulators for use with medical gases Pressure regulators and pressure regulators with flow-metering devices |
| 11/30227744 DC : DRAFT SEP 2011 | BS EN 60627 - DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS |
| 03/304751 DC : DRAFT APR 2003 | IEC 61223-3-5 ED.1.0 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| NF EN 60645-7 : 2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSES |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| 13/30282677 DC : 0 | BS EN 61669 ED.2 - ELECTROACOUSTICS - MEASUREMENT OF REAL-EAR ACOUSTICAL PERFORMANCE CHARACTERISTICS OF HEARING AIDS |
| PD IEC/TR 60977:2008 | Medical electrical equipment. Medical electron accelerators. Guidelines for functional performance characteristics |
| 13/30270474 DC : 0 | BS ISO 23500 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES |
| CEI EN 60580 : 2001 | MEDICAL ELECTRICAL EQUIPMENT DOSE AREA PRODUCT METERS |
| BS EN 60601-2-32:1995 | Medical electrical equipment. Particular requirements for safety Specification for associated equipment of X-ray equipment |
| BS 7887:1997 | Ultrasonics. Real-time pulse-echo systems. Guide for test procedures to determine performance specifications |
| BS EN 1865-5:2012 | Patient handling equipment used in road ambulances Stretcher support |
| BS EN 60601-2-68:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| BS ISO 13091-1:2001 | Mechanical vibrations. Vibrotactile perception thresholds for the assessment of nerve dysfunction Methods of measurement at the fingertips |
| 04/30088533 DC : DRAFT MARCH 2004 | BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| IEEE 1073.4.1 : 2000 | STANDARD FOR MEDICAL DEVICE COMMUNICATIONS - PHYSICAL LAYER INTERFACE - CABLE CONNECTED |
| IEEE DRAFT 1073.2 : SEP 95 | MEDICAL DEVICES COMMUNICATIONS, APPLICATION PROFILES (MDAP) - FRAMEWORK AND OVERVIEW |
| UNE-EN 62304:2007 | Medical device software - Software life-cycle processes (IEC 62304:2006) |
| 12/30271200 DC : 0 | BS EN 60601-1-9:2008/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN |
| ISO 9918:1993 | Capnometers for use with humans Requirements |
| 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 |
| 16/30295446 DC : 0 | BS ISO 19223 - LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS |
| UNE-EN 62353:2015 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| ANSI S3.6 : 2010 | SPECIFICATION FOR AUDIOMETERS |
| BS EN 60976 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS |
| 02/564070 DC : DRAFT SEP 2002 | BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| AAMI ISO 23500 : 2011 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES |
| 09/30205924 DC : 0 | BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| I.S. EN 61266:1997 | ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL HEARTBEAT DETECTORS - PERFORMANCE REQUIREMENTS AND METHODS OF MEASUREMENT AND REPORTING |
| 16/30342399 DC : 0 | BS EN 60601-2-43:2010/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| 15/30328565 DC : 0 | BS EN 60645-1 ED4.0 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY |
| 07/30161032 DC : 0 | BS EN 61391-2 - ULTRASONICS - PULSE ECHO SCANNERS - PART 2: TECHNIQUES FOR MEASUREMENT OF MAXIMUM DEPTH OF VISUALIZATION AND THE DISPLAYED DYNAMIC RANGE |
| BS EN 60601-1-9 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN |
| AAMI ISO 10079-3 : 1999 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE |
| AAMI ISO 81060-1:2007(R2013) | NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
| 16/30349981 DC : 0 | BS EN 80601-2-59 ED 2.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING |
| XP ISO/TS 22595-1 : 2007 XP | DENTISTRY - PLANT AREA EQUIPMENT - PART 1: SUCTION SYSTEMS |
| BS EN 60601-1-1:2001 | Medical electrical equipment. General requirements for safety Collateral standard. Safety requirements for medical electrical systems |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| CSA Z10079.3 : 2003 : R2013 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE |
| BS EN 60601-1-4:1997 | Medical electrical equipment. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems |
| AAMI IEC 62366 : 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| 04/30099768 DC : DRAFT DEC 2004 | PREN ISO 8835-3 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: ANAESTHETIC GAS SCAVENGING SYSTEMS - TRANSFER AND RECEIVING SYSTEMS |
| CSA Z18779 : 2008 : R2013 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| CSA IEC 62366 : 2014 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| AAMI IEC 60601-2-20 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSPORT INCUBATORS |
| ISO 7176-9:2009 | Wheelchairs Part 9: Climatic tests for electric wheelchairs |
| CEI EN 60976 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS |
| CSA Z8836 : 2011 : FR | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| UNI EN ISO 20072 : 2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| 07/30173584 DC : 0 | BS EN 60645-7 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY EVOKED POTENTIALS |
| BS 5724-2.119(1991) : 1991 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR BABY INCUBATORS |
| 03/106547 DC : DRAFT APR 2003 | ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS |
| UNI EN ISO 8836 : 2015 | A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| 03/103294 DC : DRAFT JAN 2003 | BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
| BS EN ISO 81060-2:2014 | Non-invasive sphygmomanometers Clinical investigation of automated measurement type |
| CSA Z10524-4 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| UNE-EN ISO 8836:2015 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| AAMI ID26 : 2004 : R2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| 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 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 |
| 06/30145777 DC : DRAFT FEB 2006 | ISO 10650-2 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS |
| BS EN ISO 11073-30400:2012 | Health informatics. Point-of-care medical device communication Interface profile. Cabled Ethernet |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| BS EN 60601-3-1:1997 | Medical electrical equipment. Particular requirements for performance Specification for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment |
| DD ISO/TS 11080:2009 | Dentistry. Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water |
| AAMI EC71 : 2001 : R2007 | STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| CSA Z9919 :2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| CAN/CSA-Z7376:12 (R2017) | Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Adopted ISO 7376:2009, second edition, 2009-08-15, with Canadian deviations) |
| CSA Z8836 : 2011 : R2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| 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) |
| ISO/IEEE 11073-10427:2018 | Health informatics — Personal health device communication — Part 10427: Device specialization — Power status monitor of personal health devices |
| UNE-EN ISO 80601-2-56:2013 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009) |
| AAMI IEC 62304 : 2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
| CSA C22.2 No. 60601.2.17 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| ISO 18397:2016 | Dentistry Powered scaler |
| ISO 10942:2006 | Ophthalmic instruments Direct ophthalmoscopes |
| BS EN 60731:2012 | Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy |
| IEC 60335-2-69:2016 RLV | Household and similar electrical appliances - Safety - Part 2-69: Particular requirements for wet and dry vacuum cleaners, including power brush, for commercial use |
| IEC 61675-2:2015 | Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging |
| PREN ISO 80369-1 : DRAFT 2009 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| IEEE/ANSI C63.27-2017 | American National Standard for Evaluation of Wireless Coexistence |
| AAMI ISO 5356-1 : 2004 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS |
| 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 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 |
| I.S. EN ISO 20608:2018 | DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018) |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| I.S. EN ISO 23500:2015 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014) |
| 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) |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| I.S. EN ISO 10637:2000 | DENTAL EQUIPMENT - HIGH- AND MEDIUM-VOLUME SUCTION SYSTEMS |
| I.S. EN 62366-1:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| BS EN 60601-2-37 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
| I.S. EN 60645-1:2017 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY |
| 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 60601-1-12:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| I.S. EN ISO 15752:2010 | OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| AAMI ISO 14708-5 : 2010 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| I.S. EN 61140:2016 | PROTECTION AGAINST ELECTRIC SHOCK - COMMON ASPECTS FOR INSTALLATION AND EQUIPMENT |
| BS EN 62366 : 2008 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| AAMI/IEC TIR62296:2009 | |
| 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) |
| I.S. EN 60601-1-1:2001 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| 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 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 |
| I.S. EN ISO 23328-2:2009 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| I.S. EN 60417-1:2002 | GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: OVERVIEW AND APPLICATION |
| I.S. EN 61910-1:2014 | MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY |
| CSA C22.2 No. 601.2.26 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROENCEPHALOGRAPHS |
| 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) |
| CEI 62-105 : 2000 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2: CONSTANCY TESTS - FILM PROCESSORS |
| CSA ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
| PREN 12184 : DRAFT 2011 | ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - 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) |
| EN 60601-2-40:1998 | Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment |
| I.S. EN 61331-2:2014 | PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES |
| EN 60601-2-43:2010/A1:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017) |
| 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) |
| CSA C22.2 No. 60601-2-68 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| ASTM F 1690 : 1996 : R2004 | Standard Specification for Humidifiers for Medical Use—Part 1: General Requirements for Active Humidification Systems (Withdrawn 2013) |
| AAMI ISO 5362 : 2006 | ANAESTHETIC RESERVOIR BAGS |
| CEI EN 60601-2-17 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
| CSA C22.2 No. 601.2.19 : 1992 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF BABY INCUBATORS |
| UNE-EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| ASTM F 1101 : 1990 : R2003 : EDT 1 | Standard Specification for Ventilators Intended for Use During Anesthesia (Withdrawn 2012) |
| CSA Z8835.2 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS |
| HD 395.2.7 : 200S1 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS |
| ASTM F 1456 : 2001 | Standard Specification for Minimum Performance and Safety Requirements for Capnometers |
| EN ISO 7488:2018 | Dentistry - Mixing machines for dental amalgam (ISO 7488:2018) |
| 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) |
| 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) |
| BS EN ISO 10524-2:2006 | Pressure regulators for use with medical gases Manifold and line pressure regulators |
| EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| ISO 80601-2-56:2017 | Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
| I.S. EN 61223-3-2:2008 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| ISO 80601-2-55:2018 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 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 14971:2012 | Medical devices. Application of risk management to medical devices |
| IEC TR 63167:2018 | Assessment of contact current related to human exposure to electric, magnetic and electromagnetic fields |
| ISO 22374:2005 | Dentistry Dental handpieces Electrical-powered scalers and scaler tips |
| ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| IEC TR 62653:2012 | Guideline for safe operation of medical equipment used for haemodialysis treatments |
| I.S. EN 60645-5:2005 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE |
| NF EN ISO 19980 : 2012 | OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS |
| IEC 60335-2-69:2016 | Household and similar electrical appliances - Safety - Part 2-69: Particular requirements for wet and dry vacuum cleaners, including power brush, for commercial use |
| I.S. EN 62041:2010 | SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND COMBINATIONS THEREOF - EMC REQUIREMENTS |
| 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 62304:2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| 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 |
| I.S. EN ISO 8836:2014 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| ISO 81060-2:2013 | Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type |
| DIN EN ISO 22523:2007-04 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| DIN EN 12470-3:2009-11 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| DIN EN 12470-4:2009-11 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| 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 ISO 12865:2006-10 | Ophthalmic instruments - Retinoscopes (ISO 12865:2006) |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| DIN EN ISO 12866:2009-03 | OPHTHALMIC INSTRUMENTS - PERIMETERS |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| 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 ISO 15001:2012-06 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| IEC 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures Particular requirements |
| BS EN 957-1:2005 | Stationary training equipment General safety requirements and test methods |
| BS EN ISO 9919:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| IEC 60645-6:2009 | Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
| ISO 8835-2:2007 | Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems |
| IEC 60645-7:2009 | Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses |
| ISO 8835-3:2007 | Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems |
| BS EN ISO 15606:2000 | Dental handpieces. Air-powered scalers and scaler tips |
| BS EN ISO 9703-3:1999 | Anaesthetic and respiratory care alarm signals Guidance on application of alarms |
| ISO 7785-2:1995 | Dental handpieces Part 2: Straight and geared angle handpieces |
| IEC 61223-3-2:2007 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| BS EN ISO 10939:2017 | Ophthalmic instruments. Slit-lamp microscopes |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| BS EN ISO 23747:2015 | Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| IEC 60601-2-37:2007+AMD1:2015 CSV | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| BS EN ISO 11196:1997 | Anaesthetic gas monitors |
| BS EN 60601-2-17:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
| ISO 10650-2:2007 | Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps |
| 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 |
| UNE-EN ISO 10943:2012 | Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011) |
| UNE-HD 60364-7-710:2014 | Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations |
| 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 |
| IEC 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| BS EN 12470-5:2003 | Clinical thermometers Performance of infra-red ear thermometers (with maximum device) |
| BS EN 957-6 : 2010 | STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS |
| UNE-EN ISO 8612:2010 | Ophthalmic instruments - Tonometers (ISO 8612:2009) |
| BS EN ISO 21969:2009 | High-pressure flexible connections for use with medical gas systems |
| UNE-EN ISO 26782:2010 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) |
| IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
| IEC 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| IEC 60645-5:2004 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
| IEC 60601-2-17:2013 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
| ISO 10939:2017 | Ophthalmic instruments — Slit-lamp microscopes |
| IEC 61331-1:2014 | Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials |
| I.S. EN 1064:2005 | HEALTH INFORMATICS - STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| EN ISO 7376:2009 | Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) |
| NASA STD 3001 VOL 2 : 2015 | NASA SPACE FLIGHT HUMAN-SYSTEM STANDARD - VOLUME 2: HUMAN FACTORS, HABITABILITY, AND ENVIRONMENTAL HEALTH |
| NASA JSC 08080-2 : 2015 | JSC DESIGN AND PROCEDURAL STANDARDS |
| I.S. EN ISO 7376:2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| EN 41003:2008 | Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system |
| EN 1064:2005+A1:2007 | Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| EN ISO 8836:2014 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| EN 60601-1-12:2015 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| I.S. EN 1820:2005 | ANAESTHETIC RESERVOIR BAGS |
| EN 60601-1-9:2008/A1:2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007/A1:2013) |
| EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
| EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| UNI EN 12470-3 : 2009 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| UNI EN 12470-4 : 2009 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| UNI EN ISO 10341 : 2013 | OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS |
| UNI EN ISO 6875 : 2011 | DENTISTRY - PATIENT CHAIR |
| UNI EN ISO 11252 : 2013 | LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION |
| UNI EN ISO 21647 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| UNI EN ISO 10343 : 2014 | OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS |
| 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 1640 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| UNI EN ISO 11904-1 : 2006 | ACOUSTICS - DETERMINATION OF SOUND IMMISSION FROM SOUND SOURCES PLACED CLOSE TO THE EAR - PART 1: TECHNIQUE USING A MICROPHONE IN A REAL EAR (MIRE TECHNIQUE) |
| CSA Z8835.4 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| UNI EN ISO 10342 : 2010 | OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS |
| UNI EN 1639 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| UNI EN ISO 10944 : 2009 | OPHTHALMIC INSTRUMENTS - SYNOPTOPHORES |
| 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 |
| UNI EN ISO 8835-5 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| UNI EN ISO 10943 : 2011 | OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES |
| UNI EN 12184 : 2014 | ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 17510-2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| UNI EN ISO 12866 : 2009 | OPHTHALMIC INSTRUMENTS - PERIMETERS |
| UNI EN ISO 10940 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS |
| UNI EN ISO 9360-1 : 2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML |
| UNI EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
| UNI EN ISO 21969 : 2010 | HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS |
| UNI EN 12312-14 : 2014 | AIRCRAFT GROUND SUPPORT EQUIPMENT - SPECIFIC REQUIREMENTS - PART 14: DISABLED/INCAPACITATED PASSENGER BOARDING VEHICLES |
| UNI EN ISO 18777 : 2009 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| I.S. EN ISO 11608-4:2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| EN ISO 9919:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
| UNI EN ISO 9919 : 2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
| UNI EN 957-6 : 2014 | STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS |
| UNI EN 13544-1 : 2009 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI EN 12342 : 2009 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| UNI CEI EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| 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 |
| UNI EN 794-1 : 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| UNI EN ISO 18778 : 2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| UNI EN 1820 : 2009 | ANAESTHETIC RESERVOIR BAGS |
| UNI EN ISO 8185 : 2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| UNI EN ISO 8612 : 2009 | OPHTHALMIC INSTRUMENTS - TONOMETERS |
| UNI EN ISO 8359 : 2012 | OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS |
| UNI EN ISO 8835-4 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| UNI EN ISO 11143 : 2008 | DENTISTRY - AMALGAM SEPARATORS |
| UNE-EN 60601-2-44:2010 | Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
| CEI EN 60522 : 2001 | DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES |
| BS ISO 16571:2014 | Systems for evacuation of plume generated by medical devices |
| I.S. EN ISO 13958:2015 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
| CSA C22.2 No. 60601-1-9 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN |
| ANSI/AAMI HA60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
| 16/30342393 DC : 0 | BS EN 60601-2-65:2013/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT |
| DIN EN ISO 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS ISO 7176-9:2009 | Wheelchairs Climatic tests for electric wheelchairs |
| 12/30258857 DC : 0 | BS EN 60601-1-6/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| 14/30277509 DC : 0 | BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS |
| IEEE 11073-10419-2015 | IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump |
| BS 5724-2.120(1991) : 1991 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR TRANSPORT INCUBATORS |
| 14/30244508 DC : 0 | BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| BS EN ISO 20072:2013 | Aerosol drug delivery device design verification. Requirements and test methods |
| 08/30192448 DC : DRAFT DEC 2008 | BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| 17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
| 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 |
| NF 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 |
| DIN 6875-20:2016-08 | SPECIAL RADIOTHERAPY EQUIPMENTS - PART 20: PROTON THERAPY - RULES FOR CONSTRUCTION OF STRUCTURAL RADIATION PROTECTION |
| CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| 13/30250915 DC : 0 | BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
| BS ISO/IEEE 11073-00103 : 2015 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
| NF EN 60601-2-66 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
| 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 |
| 03/111582 DC : DRAFT JULY 2003 | BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| 13/30216789 DC : 0 | BS EN 60601-2-64 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL LIGHT ION BEAM MEDICAL EQUIPMENT |
| I.S. EN ISO 21647:2009 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| BS ISO 10343 : 1997 AMD 10608 | OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS |
| 08/30170500 DC : DRAFT JUNE 2008 | BS EN 60601-2-33 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| I.S. EN ISO 7785-2:1998 | DENTAL HANDPIECES - PART 2: STRAIGHT AND GEARED ANGLE HANDPIECES |
| BS ISO 18835:2015 | Inhalational anaesthesia systems. Draw-over anaesthetic systems |
| I.S. EN 62274:2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
| 16/30332194 DC : 0 | BS ISO 10936-1 - OPTICS AND PHOTONICS - OPERATION MICROSCOPES - PART 1: REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 8835-2 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
| 17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
| 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 |
| 12/30271192 DC : 0 | BS IEC 60601-1-3 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| NF EN 60601-1-9 : 2008 AMD 1 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN |
| 03/113375 DC : DRAFT AUG 2003 | BS EN ISO 22374 - DENTISTRY - DENTAL HANDPIECES - ELECTRICAL-POWERED SCALERS AND SCALER TIPS |
| EN 60601-1-1:2001 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| BS EN ISO 18397:2016 | Dentistry. Powered scaler |
| 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 |
| 02/563809 DC : DRAFT SEP 2002 | BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| 08/30188786 DC : 0 | IEC 60613 - ELECTRICAL, THERMAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| I.S. EN ISO 10650-2:2007 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS |
| 08/30176438 DC : DRAFT JAN 2008 | BS EN 60645-1 - ELECTRO ACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: PURE-TONE AUDIOMETERS |
| 05/30134824 DC : 0 | EN 50447 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR HEART-LUNG MACHINES (HLM) |
| 12/30241725 DC : 0 | BS ISO 28057 - DOSIMETRY WITH SOLID THERMOLUMINSCENCE DETECTORS FOR PHOTON AND ELECTRON RADIATIONS IN RADIOTHERAPY |
| 12/30245174 DC : 0 | BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| 09/30194820 DC : 0 | BS EN 60731 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY |
| 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 |
| BS 7259-2(1993) : AMD 9349 | NON-ELECTRICAL MEDICAL SUCTION EQUIPMENT - SPECIFICATION FOR SUCTION EQUIPMENT POWERED FROM VACUUM OR PRESSURE SOURCE |
| BS ISO 11498 : 1997 AMD 10705 | DENTAL HANDPIECES - DENTAL LOW-VOLTAGE ELECTRIC MOTORS |
| BS ISO 81060-2 : 2013 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
| 07/30173580 DC : 0 | BS EN 60645-6 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| AAMI 23500 : 2014 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES |
| IEC 60601-2-68:2014 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 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 |
| 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 |
| BS EN 60601-2-24:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| 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 |
| 15/30322764 DC : 0 | BS EN 60601-2-6 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT - PROPOSED HORIZONTAL STANDARD |
| CEI EN 62041 : 2012 | SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND COMBINATIONS THEREOF - EMC REQUIREMENTS |
| 09/30155521 DC : 0 | BS EN 60601-1-11 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| AAMI NS4 :2013 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS |
| 14/30257546 DC : 0 | BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS |
| 07/30168606 DC : 0 | BS ISO 11073-91064 - HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 91064: STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| 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) |
| BS EN 60598-2-25:1995 | Luminaires. Particular requirements Luminaires for use in clinical areas of hospitals and health care buildings |
| BS ISO 8835-2:1999 | Inhalational anaesthesia systems Anaesthetic breathing systems for adults |
| 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) |
| CEI EN 60118-14 : 1999 | HEARING AIDS - PART 14: SPECIFICATION OF A DIGITAL INTERFACE |
| BS EN ISO 11073-10441:2017 | Health informatics. Personal health device communication Device specialization. Cardiovascular fitness and activity monitor |
| CSA C22.2 No. 60601.1.1 : 2002 : R2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| CSA Z10079.3 : 2003 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE |
| I.S. EN 60335-2-69:2012 | HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-69: PARTICULAR REQUIREMENTS FOR WET AND DRY VACUUM CLEANERS, INCLUDING POWER BRUSH FOR COMMERCIAL USE (IEC 60335-2-69:2012 (MOD)) |
| 08/30149952 DC : DRAFT MAY 2008 | BS EN 60601-2-54 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| 13/30272807 DC : 0 | BS ISO 18835 - INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT |
| BS EN ISO 11073-00103:2017 | Health informatics. Personal health device communication Overview |
| BS EN 60601-1-2:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests |
| 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 |
| DIN EN ISO 16954:2015-11 | DENTISTRY - TEST METHODS FOR DENTAL UNIT WATERLINE BIOFILM TREATMENT (ISO 16954:2015) |
| 12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| BS EN 62041:2010 | Safety of transformers, reactors, power supply units and combinations thereof. EMC requirements |
| UNI EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| NF EN 60645-6 : 2010 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
| 04/30103854 DC : DRAFT JUN 2004 | ISO 15004-1 - OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| UNI EN ISO 8835-3 : 2010 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| 10/30217545 DC : 0 | BS EN 61674 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING |
| BS 5724-2.18(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT |
| BS EN 60645-1:2017 | Electroacoustics. Audiometric equipment Equipment for pure-tone and speech audiometry |
| I.S. EN 61669:2016 | ELECTROACOUSTICS - MEASUREMENT OF REAL-EAR ACOUSTICAL PERFORMANCE CHARACTERISTICS OF HEARING AIDS |
| BS EN IEC 62667:2018 | Medical electrical equipment. Medical light ion beam equipment. Performance characteristics |
| BS EN 60645-5:2005 | Electroacoustics. Audiometric equipment Instruments for the measurement of aural acoustic impedance/admittance |
| CEI EN 62083 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| BS 7748(1994) : 1994 AMD 9228 | SPECIFICATION FOR DENTAL OPERATING LIGHT |
| 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 |
| UNI CEI EN ISO 14971 : 2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| 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 |
| 14/30291827 DC : DRAFT AUG 2014 | BS EN 61675-2 ED.2 - RADIONUCLIDE IMAGING DEVICES - CHARACTERISTICS AND TEST CONDITIONS - PART 2: GAMMA CAMERAS FOR PLANAR IMAGING AND SPECT IMAGING |
| BS EN 61223-3-1:1999 | Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems |
| 12/30253196 DC : 0 | BS EN 60601-2-36 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTRACORPOREALLY INDUCED LITHOTRIPSY |
| 08/30173112 DC : DRAFT AUG 2008 | BS EN ISO 8612 - OPHTHALMIC INSTRUMENTS - TONOMETERS |
| 01/561640 DC : DRAFT APR 2001 | BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| NF ISO 16971 : 2015 | OPHTHALMIC INSTRUMENTS - OPTICAL COHERENCE TOMOGRAPH FOR THE POSTERIOR SEGMENT OF THE HUMAN EYE - INSTRUMENTS OPHTALMIQUES |
| CSA Z8185 : 2008(R2013) | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| NF EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| BS EN ISO 22374:2005 | Dentistry. Dental handpieces. Electrical-powered scalers and scaler tips |
| CSA Z8185 : 2008 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| 09/30192353 DC : 0 | BS EN 12470-3:2000/A1 - CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| CSA Z15001 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN |
| CAN/CSA-Z18777-08 (R2018) | Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations) |
| CSA Z7376 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| BS EN ISO 16954:2015 | Dentistry. Test methods for dental unit waterline biofilm treatment |
| AAMI ISO 14708-4 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| 17/30357890 DC : 0 | BS ISO 20495 - TRADITIONAL CHINESE MEDICINE - SKIN ELECTRICAL RESISTANCE MEASUREMENT DEVICE |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| IEEE C95.1-2005 | IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz |
| CSA Z21647:2007 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| 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 |
| CSA Z18777 : 2008 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| CAN/CSA-Z15001:12 (R2017) | Anaesthetic and respiratory equipment - Compatibility with oxygen (Adopted ISO 15001:2010, second edition, 2010-06-01, with Canadian deviations) |
| ANSI Z80.11 : 2012 : R2017 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| CSA Z10079.1 : 2003 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT - SAFETY REQUIREMENTS |
| 17/30325386 DC : 0 | BS ISO 18250-1- CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 1: GENERAL REQUIREMENTS AND COMMON TEST METHODS |
| 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) |
| CEI EN 60601-1-1 : 2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| I.S. EN 61168:1994 | RADIOTHERAPY SIMULATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS |
| AAMI ISO 14971 : 2007 : R2010 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| AAMI 13958 : 2014 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
| CSA Z8835.5 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| CSA Z9918 : 0 | CAPNOMETERS FOR USE WITH HUMANS - REQUIREMENTS |
| CSA ISO TS 18835 : 2014 | INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT |
| I.S. EN ISO 7494-1:2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| IEEE/ANSI C63.18-2014 | American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
| I.S. EN 61675-2:2015 | RADIONUCLIDE IMAGING DEVICES - CHARACTERISTICS AND CONDITIONS - PART 2: GAMMA CAMERAS FOR PLANAR, WHOLEBODY, AND SPECT IMAGING |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| NF EN 60601-1-4 : 1999 AMD 1 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| 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 |
| ANSI/AAMI/ISO 14708-3:2017 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| 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) |
| EN 60601-2-68:2015 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| AAMI ISO 11195 : 1995 | GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS |
| ANSI/AAMI/ISO 80369-6:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS |
| I.S. EN ISO 15002:2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| 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) |
| NF ISO 18190 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| CSA CEI/IEC 62304:14 (R2019) | Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05) |
| I.S. EN 60601-2-68:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| ISO 14708-5:2010 | Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
| I.S. EN 60601-2-40:1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| ASTM F 1831 : 2017 : REDLINE | Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices |
| STANAG 2979 : 0 | ESSENTIAL CHARACTERISTICS OF ELECTROSURGICAL APPARATUS |
| EN ISO 11197:2016 | Medical supply units (ISO 11197:2016) |
| ISO 14708-4:2008 | Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps |
| NF EN 60601 1-3 : 2008 AMD 1 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT |
| 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 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| I.S. EN 60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| DIN EN ISO 5367:2015-02 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| GOST R ISO 8528-12 : 2005 | RECIPROCATING INTERNAL COMBUSTION ENGINE DRIVEN ALTERNATING CURRENT GENERATING SETS - PART 12: EMERGENCY POWER SUPPLY TO SAFETY SERVICES |
| NF EN ISO 10637 : 2001 | DENTAL EQUIPMENT - HIGH- AND MEDIUM-VOLUME SUCTION SYSTEMS |
| CEI EN 61266 : 1998 | ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL HEARTBEAT DETECTORS - PERFORMANCE REQUIREMENTS AND METHODS OF MEASUREMENT AND REPORTING |
| CEI EN 61674 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING |
| NF EN 60601-2-40 : 2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENTS |
| I.S. EN 61223-3-5:2004 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
| DIN EN ISO 5359:2015-02 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| BS EN ISO 7494-1:2011 | Dentistry. Dental units General requirements and test methods |
| IEEE 11073-10427-2016 | IEEE Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices |
| 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 |
| ISO 17966:2016 | Assistive products for personal hygiene that support users Requirements and test methods |
| EN IEC 62667:2018 | Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
| 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 |
| NF EN ISO 81060-2 : 2014 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
| AAMI ISO 26782 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
| ASTM F 1690 : 1996 | Standard Specification for Humidifiers for Medical Use-Part 1 General Requirements for Active Humidification Systems |
| CEI EN 60601-3-1 : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PART 3-1: ESSENTIAL PERFORMANCE REQUIREMENTS FOR TRANSCUTANEOUS OXYGEN AND CARBON DIOXIDE PARTIAL PRESSURE MONITORING EQUIPMENT |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| DIN EN ISO 10650:2016-02 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| BS EN ISO 11197:2009 | Medical supply units |
| UNI EN 13976-1 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| ISO 10524-2:2018 | Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators |
| EN ISO 20608:2018 | Dentistry - Powder jet handpieces and powders (ISO 20608:2018) |
| 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 28057:2014 | Dosimetry with solid thermoluminescence detectors for photon and electron radiations in radiotherapy |
| ISO 14708-7:2013 | Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems |
| DIN EN ISO 80369-1:2015-09 (Draft) | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| EN ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
| ISO 18835:2015 | Inhalational anaesthesia systems Draw-over anaesthetic systems |
| 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) |
| I.S. EN 60601-2-43:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
| I.S. HD 395-2-7:1990 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS |
| EN ISO 81060-2:2014 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013) |
| I.S. EN 60601-2-44:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
| IEC PAS 61910-1:2007 | Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| IEC 62041:2017 | Transformers, power supplies, reactors and similar products - EMC requirements |
| I.S. EN 60580:2000 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
| I.S. EN 60601-1-9:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007 (EQV)) |
| IEC 60601-2-54:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy |
| I.S. EN 60601-2-38:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| IEC 80601-2-59:2017 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
| I.S. EN 60731:2012 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV)) |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| IEC TR 62354:2014 | General testing procedures for medical electrical equipment |
| ISO 10651-5:2006 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators |
| IEC 61204-3:2016 | Low-voltage switch mode power supplies - Part 3: Electromagnetic compatibility (EMC) |
| EN 60601-2-44:2009/A2:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016) |
| UNE-EN 60645-1:2015 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone audiometry |
| 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 ISO 8835-5:2009-07 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| UNE-EN ISO 6875:2012 | Dentistry - Patient chair (ISO 6875:2011) |
| DIN EN ISO 10079-1:2016-05 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
| DIN EN ISO 16201:2006-12 | Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006) |
| DIN EN ISO 15004-1:2009-07 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006); German version EN ISO 15004-1:2009 |
| IEC 60645-1:2017 RLV | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
| 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 |
| BS EN ISO 8185:2007 | Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ISO 9360-1:2000 | Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml |
| BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
| ISO 18778:2005 | Respiratory equipment — Infant monitors — Particular requirements |
| BS EN 61558-2-16 : 2009 | SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND SIMILAR PRODUCTS FOR SUPPLY VOLTAGES UP TO 1100 V - PART 2-16: PARTICULAR REQUIREMENTS AND TESTS FOR SWITCH MODE POWER SUPPLY UNITS AND TRANSFORMERS FOR SWITCH MODE POWER SUPPLY UNITS |
| 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) |
| BS EN 13819-2:2002 | Hearing protectors. Testing Acoustic test methods |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| IEC 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| IEC 62464-1:2007 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| IEC 60601-2-65:2012+AMD1:2017 CSV | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
| IEC 61223-2-6:2006 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests imaging performance of computed tomography X-ray equipment |
| ISO 11904-1:2002 | Acoustics — Determination of sound immission from sound sources placed close to the ear — Part 1: Technique using a microphone in a real ear (MIRE technique) |
| ISO 17510-2:2007 | Sleep apnoea breathing therapy Part 2: Masks and application accessories |
| BS EN 1820:2005 | Anaesthetic reservoir bags |
| 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 7376:2009 | Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation |
| EN 60580:2000 | Medical electrical equipment - Dose area product meters |
| ISO 21969:2009 | High-pressure flexible connections for use with medical gas systems |
| 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 |
| IEC 61331-2:2014 | Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates |
| BS EN 61267:2006 | Medical diagnostic X-ray equipment. Radiation conditions for use in the determination of characteristics |
| ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| ISO 16954:2015 | Dentistry — Test methods for dental unit waterline biofilm treatment |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| BS EN ISO 15004:1998 | Ophthalmic instruments. Fundamental requirements and test methods |
| 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 |
| BS EN ISO 10079-3:2014 | Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source |
| 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 |
| BS EN ISO 7785-1:1999 | Dental handpieces High-speed air turbine handpieces |
| BS EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods |
| BS EN ISO 18778:2009 | Respiratory equipment. Infant monitors. Particular requirements |
| BS EN ISO 7785-2:1998 | Dental handpieces Straight and geared angle handpieces |
| BS EN ISO 11608-4:2007 | Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60976:2007 | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| ISO 11498:1997 | Dental handpieces Dental low-voltage electrical motors |
| IEC 60789:2005 | Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras |
| ISO 20072:2009 | Aerosol drug delivery device design verification Requirements and test methods |
| EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| ISO 15004-1:2006 | Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments |
| IEC 60731:2011+AMD1:2016 CSV | Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
| BS EN 61140 : 2002 | PROTECTION AGAINST ELECTRIC SHOCK - COMMON ASPECTS FOR INSTALLATION AND EQUIPMENT |
| IEC 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| 14/30315309 DC : 0 | BS EN 61204-3 - LOW VOLTAGE POWER SUPPLIES, D.C. OUTPUT - PART 3: ELECTROMAGNETIC COMPATIBILITY (EMC) |
| ISO 7785-1:1997 | Dental handpieces Part 1: High-speed air turbine handpieces |
| UNE-EN ISO 10939:2017 | Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017) |
| ISO 10944:2009 | Ophthalmic instruments — Synoptophores |
| ISO 10650-1:2004 | Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps |
| BS EN 12470-4 : 2001 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| IEC 60598-2-25:1994 | Luminaires - Part 2: Particular requirements - Section 25: Luminaires for use in clinical areas of hospitals and health care buildings |
| 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 |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| ISO 10943:2011 | Ophthalmic instruments — Indirect ophthalmoscopes |
| ISO 10341:2012 | Ophthalmic instruments — Refractor heads |
| 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/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
| ISO 6875:2011 | Dentistry Patient chair |
| ISO 23500:2014 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
| IEC 62494-1:2008 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| ISO 18777:2005 | Transportable liquid oxygen systems for medical use — Particular requirements |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| 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 |
| IEC 61266:1994 | Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| ISO 10342:2010 | Ophthalmic instruments Eye refractometers |
| ISO 15606:1999 | Dental handpieces Air-powered scalers and scaler tips |
| ISO 12865:2006 | Ophthalmic instruments Retinoscopes |
| ISO 11252:2013 | Lasers and laser-related equipment — Laser device — Minimum requirements for documentation |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular 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 |
| BS EN ISO 6875:2011 | Dentistry. Patient chair |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| IEC 60601-3-1:1996 | Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment |
| BS EN ISO 8612:2009 | Ophthalmic instruments. Tonometers |
| ISO 22523:2006 | External limb prostheses and external orthoses — Requirements and test methods |
| IEC 61267:2005 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
| IEC 60601-2-36:2014 | Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
| BS EN 60601-1-3 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008) |
| 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 |
| IEC 60601-2-30:1999 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| UNE-EN ISO 19980:2012 | Ophthalmic instruments - Corneal topographers (ISO 19980:2012) |
| UNE-EN 12184:2014 | Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| IEC 61391-2:2010 | Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| ISO 8835-4:2004 | Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices |
| UNE-EN 45502-2-3:2010 | Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| IEC 61223-3-4:2000 | Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment |
| BS EN ISO 11073-30200 : 2005 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED |
| ISO 10940:2009 | Ophthalmic instruments — Fundus cameras |
| BS EN ISO 10342:2010 | Ophthalmic instruments. Eye refractometers |
| IEC 61674:2012 | Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| BS EN ISO 11252:2013 | Lasers and laser-related equipment. Laser device. Minimum requirements for documentation |
| BS EN ISO 10940:2009 | Ophthalmic instruments. Fundus cameras |
| IEC TR 61289:2011 | High frequency surgical equipment - Operation and maintenance |
| ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| UNE-EN ISO 10341:2013 | Ophthalmic instruments - Refractor heads (ISO 10341:2012) |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| BS EN ISO 10650-2:2007 | Dentistry. Powered polymerization activators Light-emitting diode (LED) lamps |
| UNE-EN 62083:2010 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| ISO 8612:2009 | Ophthalmic instruments — Tonometers |
| ISO 7494:1996 | Dental units |
| IEC 60627:2013 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| ISO 12866:1999 | Ophthalmic instruments Perimeters |
| BS EN 61217:2012 | Radiotherapy equipment. Coordinates, movements and scales |
| BS EN ISO 11143:2008 | Dental equipment. Amalgam separators |
| UNE-EN ISO 10343:2014 | Ophthalmic instruments - Ophthalmometers (ISO 10343:2014) |
| ISO 8359:1996 | Oxygen concentrators for medical use Safety requirements |
| BS EN 61204-7:2006 | Live working. Conductive clothing Safety requirements |
| BS EN 61223-2-6:2007 | Evaluation and routine testing in medical imaging departments Constancy tests. Imaging performance of computed tomography X-ray equipment |
| ISO 16201:2006 | Technical aids for persons with disability — Environmental control systems for daily living |
| BS EN 60601-2-33 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| IEC 61331-3:2014 | Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields |
| NF EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| ISO 9680:2014 | Dentistry Operating lights |
| 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 |
| IEC 62083:2009 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| BS EN ISO 10341:2012 | Ophthalmic instruments. Refractor heads |
| 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 |
| IEC 61027:1991 | Instruments for the measurement of aural acoustic impedance/admittance |
| EN 60601-2-9:1996/corrigendum:1996 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| 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 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 ISO 11904-1:2002 | Acoustics - Determination of sound immission from sound sources placed close to the ear - Part 1: Technique using a microphone in a real ear (MIRE technique) (ISO 11904-1:2002) |
| EN 13826 : 2003 | PEAK EXPIRATORY FLOW METERS |
| EN ISO 11073-00103:2017 | Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
| EN 16812:2016 | Textiles and textile products - Electrically conductive textiles - Determination of the linear electrical resistance of conductive tracks |
| EN ISO 15752:2010 | Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010) |
| EN ISO 15004 : 1997 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS |
| 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 15606:1999 | Dental handpieces - Air-powered scalers and scaler tips (ISO 15606:1999) |
| EN ISO 16954:2015 | Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015) |
| EN ISO 16201:2006 | Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006) |
| 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 10944:2009 | Ophthalmic instruments - Synoptophores (ISO 10944:2009) |
| EN ISO 10939:2017 | Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017) |
| EN ISO 23500:2015 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014) |
| EN 957-6:2010+A1:2014 | Stationary training equipment - Part 6: Treadmills, additional specific safety requirements and test methods |
| UNI EN ISO 9680 : 2015 | DENTISTRY - OPERATING LIGHTS |
| EN 1820:2005+A1:2009 | Anaesthetic reservoir bags (ISO 5362:2000, modified) |
| IEC 80601-2-30:2018 RLV | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| EN ISO 7785-1:1999 | Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997) |
| EN 12342:1998+A1:2009 | Breathing tubes intended for use with anaesthetic apparatus and ventilators |
| EN ISO 7494 : 1997 | DENTAL UNITS |
| EN ISO 8835-4:2009 | Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
| 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 8835-5:2009 | Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
| EN ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
| 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 ISO 9703-3 : 1998 | ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 3: GUIDANCE ON APPLICATION OF ALARMS |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| EN ISO 10341:2012 | Ophthalmic instruments - Refractor heads (ISO 10341:2012) |
| EN ISO 18777:2009 | Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) |
| 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 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
| 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 10342:2010 | Ophthalmic instruments - Eye refractometers (ISO 10342:2010) |
| EN ISO 10940:2009 | Ophthalmic instruments - Fundus cameras (ISO 10940:2009) |
| EN 12470-4:2000+A1:2009 | Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
| EN ISO 11143:2008 | Dentistry - Amalgam separators (ISO 11143:2008) |
| EN ISO 13294:1997 | Dental handpieces - Dental air-motors (ISO 13294:1997) |
| EN ISO 7785-2:1997 | Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995) |
| 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 9360-1:2009 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
| EN ISO 10524-4:2008 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
| EN ISO 10343:2014 | Ophthalmic instruments - Ophthalmometers (ISO 10343:2014) |
| EN ISO 15001:2011 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| EN ISO 22665:2012 | Ophthalmic optics and instruments - Instruments to measure axial distances in the eye (ISO 22665:2012) |
| EN ISO 18778:2009 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
| 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 ISO 12865:2006 | Ophthalmic instruments - Retinoscopes (ISO 12865:2006) |
| EN 957-1:2005 | Stationary training equipment - Part 1: General safety requirements and test methods |
| 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 794-1:1997+A2:2009 | Lung ventilators - Part 1: Particular requirements for critical care ventilators |
| EN ISO 11498:1999 | Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN ISO 11608-4:2007 | Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006) |
| EN ISO 10650-1:2005 | Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004) |
| EN ISO 10650-2:2007 | Dentistry - Powered polymerization activators - Part 2: Light-emitting diode (LED) lamps (ISO 10650-2:2007) |
| EN ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| EN ISO 10943:2011 | Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011) |
| 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 18397:2016 | Dentistry - Powered scaler (ISO 18397:2016) |
| EN ISO 6875:2011 | Dentistry - Patient chair (ISO 6875:2011) |
| EN ISO 8835-2:2009 | Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
| 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) |
| I.S. EN ISO 10650:2015 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| 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 |
| 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 |
| 08/30138766 DC : DRAFT MAR 2008 | BS EN ISO 10940 - OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS |
| CSA C22.2 No. 60601.2.24 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
| 05/30114972 DC : DRAFT FEB 2005 | ISO 10942 - OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES |
| BS 5724-2.124(1998) : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
| BS EN 60601-1-11:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| BS EN 60601-2-35:1997 | Medical electrical equipment. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use |
| CSA Z10524-3 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| 06/30116855 DC : 0 | BS ISO 10524-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT |
| BS EN 62494-1:2008 | Medical electrical equipment. Exposure index of digital X-ray imaging systems Definitions and requirements for general radiography |
| I.S. EN ISO 10650-1:2005 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 1: QUARTZ TUNGSTEN HALOGEN LAMPS |
| 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 |
| 14/30285182 DC : 0 | BS EN ISO 10938 - OPHTHALMIC OPTICS - CHART DISPLAYS FOR VISUAL ACUITY MEASUREMENTS - PRINTED, PROJECTED AND ELECTRONIC |
| BS 5724-2.39(1999) : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR PERITONEAL DIALYSIS EQUIPMENT |
| BS EN ISO 8835-3 : 2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| 15/30246774 DC : 0 | BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| BS 5966:1980 | Specification for audiometers |
| I.S. EN ISO 8835-5:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
| IEEE 11073-10441-2013 | Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor |
| BS EN 16812:2016 | Textiles and textile products. Electrically conductive textiles. Determination of the linear electrical resistance of conductive tracks |
| I.S. EN ISO 13294:1998 | DENTAL HANDPIECES - DENTAL AIR-MOTORS |
| CEI EN 62494-1 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY |
| 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 |
| 12/30267985 DC : 0 | BS EN 60601-2-33:2010/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| PD IEC/PAS 63077:2016 | Good refurbishment practices for medical imaging equipment |
| NF EN ISO 10524-3 : 2006 AMD 1 2013 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
| UNI EN ISO 10524-4 : 2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
| ISO/TS 11080:2009 | Dentistry Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water |
| 02/563295 DC : DRAFT AUG 2002 | BS EN ISO 5356-1 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS |
| 14/30245318 DC : 0 | BS EN ISO 16954 - DENTISTRY - TEST METHODS FOR EVALUATING ANTIBACTERIAL BIOFILM TREATMENT METHODS FOR DENTAL UNIT WATER DELIVERY SYSTEMS |
| ANSI Z80.10 : 2014 | OPHTHALMIC INSTRUMENTS - TONOMETERS |
| BS ISO 7176-25:2013 | Wheelchairs Batteries and chargers for powered wheelchairs |
| BS ISO 11197 : 2016 | MEDICAL SUPPLY UNITS |
| 14/30273278 DC : 0 | BS EN ISO 18397 - DENTISTRY - POWERED SCALER |
| 13/30258863 DC : 0 | BS EN 61910-1 ED 1.0 - MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION - PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY |
| BS EN ISO 10524-4:2008 | Pressure regulators for use with medical gases Low-pressure regulators |
| I.S. EN ISO 80369-1:2010 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| 08/30176368 DC : 0 | BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| ISO/TS 10650:1999 | Dental equipment Powered polymerization activators |
| BS EN 61391-2:2010 | Ultrasonics. Pulse-echo scanners Measurement of maximum depth of penetration and local dynamic range |
| 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) |
| DIN EN 60601-2-32 : 1995 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT |
| 12/30210881 DC : DRAFT APR 2012 | BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| DIN 6280-13:1994-12 | GENERATING SETS - RECIPROCATING INTERNAL COMBUSTION ENGINES DRIVEN GENERATING SETS - PART 13: FOR EMERGENCY POWER SUPPLY IN HOSPITALS AND PUBLIC BUILDINGS |
| CSA ISO 11196 : 0 | ANAESTHETIC GAS MONITORS |
| BS 5724-2.35(1997) : 1997 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR BLANKETS, PADS AND MATTRESSES INTENDED FOR HEATING AND MEDICAL USE |
| 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) |
| I.S. HD 60364-7-710:2012 | LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS (IEC 60364-7-710:2002 (MOD)) |
| ISO 14835-1:2016 | Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 1: Measurement and evaluation of finger skin temperature |
| NF EN 62353 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
| CSA Z10651.3 : 0 | LUNG VENTILATORS FOR MEDICAL USE - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| BS EN ISO 11073-20601:2016 | Health informatics. Personal health device communication Application profile. Optimized exchange protocol |
| 12/30242781 DC : 0 | BS EN 61331-2 - PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES |
| 07/30156568 DC : DRAFT AUG 2007 | BS ISO 12866 AMD1 - OPHTHALMIC INSTRUMENTS - PERIMETERS |
| ISO/TS 18835:2004 | Inhalational anaesthesia systems Draw-over vaporizers and associated equipment |
| 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 |
| 06/30115645 DC : DRAFT JUN 2006 | IEC 60601-1-9 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - REQUIREMENTS FOR THE REDUCTION OF ENVIRONMENTAL IMPACTS |
| BS EN 60645-7:2010 | Electroacoustics. Audiometric equipment Instruments for the measurement of auditory brainstem responses |
| BS EN 61953:1998 | Diagnostic X-ray imaging equipment. Characteristics of mammographic anti-scatter grids |
| BS EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications General requirements |
| I.S. EN 60601-2-10:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-10: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NERVE AND MUSCLE STIMULATORS |
| BS ISO 23500 : 2014 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES |
| 12/30253298 DC : 0 | BS EN ISO 10343 - OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS |
| 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/IES RP-29 : 2016 | LIGHTING FOR HOSPITALS AND HEALTH CARE FACILITIES |
| 11/30240516 DC : 0 | BS EN 12312-14 - AIRCRAFT GROUND SUPPORT EQUIPMENT - SPECIFIC REQUIREMENTS - PART 14: DISABLED/INCAPACITATED PASSENGER BOARDING VEHICLES |
| EN 60601-2-64:2015 | Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 61027:1993 | Specification for instruments for the measurement of aural acoustic impedance/admittance |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| 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 |
| BS EN 61331-3:2014 | Protective devices against diagnostic medical X-radiation Protective clothing, eyewear and protective patient shields |
| 17/30332162 DC : 0 | BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| DIN 19403:2016-08 | DENTISTRY - MULTIFUNCTION HANDPIECES |
| 11/30230872 DC : 0 | BS EN 61689 - ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ |
| BS EN 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| 00/560888 DC : APR 2000 | IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS |
| I.S. EN 60976:2007 | MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS |
| 14/30288421 DC : 0 | BS EN ISO/IEC 80369-6 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS |
| NF EN ISO 7494-1 : 2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| VDE 0750-2-40 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| IEC 61669:2015 | Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids |
| BS EN 60580:2000 | Dose area product meters |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| 15/30322777 DC : 0 | BS EN 60601-2-3 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT - PROPOSED HORIZONTAL STANDARD |
| 16/30316718 DC : 0 | BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
| BS EN 62366-1:2015 | Medical devices Application of usability engineering to medical devices |
| I.S. EN 60613:2010 | ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| CEI EN 60645-7 : 2013 | ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSE |
| UNE-EN ISO 23500:2016 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014) |
| 08/30159296 DC : DRAFT APR 2008 | BS EN ISO 15225 - NOMENCLATURE - SPECIFICATION FOR A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE |
| BS ISO 7197:1997 | Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
| 09/30178059 DC : 0 | BS ISO 7176-9 - WHEELCHAIRS - PART 9: CLIMATIC TESTS FOR ELECTRIC WHEELCHAIRS |
| 04/30081057 DC : DRAFT AUG 2004 | EN ISO 10535 - HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| 08/30174059 DC : DRAFT JUNE 2008 | BS ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL VALIDATION OF AUTOMATED MEASUREMENT TYPE |
| DIN EN 1865-5:2012-09 | Patient handling equipment used in road ambulances - Part 5: Stretcher support |
| 14/30296597 DC : 0 | BS EN 60601-2-54/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| 04/19984413 DC : DRAFT MARCH 2004 | BS ISO 14835-1 - MECHANICAL VIBRATION AND SHOCK - COLD PROVOCATION TESTS FOR THE ASSESSMENT OF PERIPHERAL VASCULAR FUNCTION - PART 1 - MEASUREMENT AND EVALUATION OF FINGER SKIN TEMPERATURE |
| I.S. EN ISO 5367:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| 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 |
| 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 |
| 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) |
| 06/30122245 DC : 0 | EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| NF 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 |
| EN ISO 10650:2015 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
| IEC TR 60601-4-4:2017 | Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements |
| CSA Z18779 : 2008 | MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
| BS IEC 60825-8:1999 | Safety of laser products Guidelines for the safe use of medical laser equipment |
| CSA ISO 5367 : 2014 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| 99/714207 DC : DRAFT SEP 1999 | ISO/DIS 13091-1 - MECHANICAL VIBRATION - VIBROTACTILE PERCEPTION THRESHOLD FOR THE ASSESSMENT OF NERVE DYSFUNCTION - PART 1: TEST METHODS FOR MEASUREMENT AT THE FINGERTIPS |
| BS EN 60601-2-9:1997 | Medical electrical equipment. Particular requirements for safety Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
| CSA Z18777 : 2008 : R2013 | TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
| AAMI ISO 14708-4:2008(R2011) | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| 05/30125283 DC : DRAFT MAY 2005 | EN ISO 12865 - OPHTHALMIC INSTRUMENTS - RETINOSCOPES |
| UNE-EN ISO 81060-2:2014 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013) |
| CSA ISO 14971 : 2007 : R2017 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CEI EN 60613 : 2010 | ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
| CSA ISO 14971 : 2007 : R2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| 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) |
| 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 |
| ISO 11195:2018 | Gas mixers for medical use — Stand-alone gas mixers |
| CSA Z21647 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| 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) |
| ISO 5358:1992 | Anaesthetic machines for use with humans |
| UNE-EN ISO 10079-1:2016 | Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) |
| CEI EN 61267 : 2006 | MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS |
| CSA CEI/IEC 1289.2 : 1998 | HIGH-FREQUENCY SURGICAL EQUIPMENT - PART 2: MAINTENANCE |
| 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) |
| UNE-EN ISO 22665:2013 | Ophthalmic optics and instruments - Instruments to measure axial distances in the eye (ISO 22665:2012) |
| 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 62467-1:2015 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS |
| I.S. EN 60601-2-30:2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| IEEE 11073-00103-2012 | Health informatics - Personal health device communication Part 00103: Overview |
| CEI EN 60601-2-26 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| IEEE/ANSI C63.12-2015 | American National Standard Recommended Practice for Electromagnetic Compatibility Limits and Test Levels |
| I.S. EN 60627:2015 | DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS |
| I.S. EN 60601-2-37:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
| 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) |
| IEEE 11073-10418-2011 | IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor |
| NF EN 61331-3 : MAY 2015 | PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS |
| I.S. EN 60522:1999 | DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES |
| NF EN 60601 2-3 : 2015 AMD 1 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT |
| BS IEC 82304-1 : 2016 | HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| I.S. EN ISO 81060-2:2014 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013) |
| AAMI IEC 62366-1 : 2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| 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 |
| I.S. EN 61331-3:2014 | PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS |
| CEI 62-143 : 2007 | MAPPING BETWEEN THE CLAUSES OF THE THIRD EDITION OF IEC 60601-1 AND THE 1988 EDITION AS AMENDED |
| I.S. EN ISO 7488:1996 | DENTISTRY - MIXING MACHINES FOR DENTAL AMALGAM (ISO 7488:2018) |
| I.S. EN ISO 8835-3:2009 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| BS EN ISO 10079-1:2015 | Medical suction equipment Electrically powered suction equipment |
| ISO 10650:2015 | Dentistry Powered polymerization activators |
| 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 |
| ISO 5362:2006 | Anaesthetic reservoir bags |
| BS EN 62304 : 2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| 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) |
| 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 |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| ISO 8528-12:1997 | Reciprocating internal combustion engine driven alternating current generating sets — Part 12: Emergency power supply to safety services |
| ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs) |
| NF EN 60598-2-25 : 1995 AMD 1 2005 | LUMINARIES - PART 2-25: PARTICULAR REQUIREMENTS - LUMINARIES FOR USE IN CLINICAL AREAS OF HOSPITALS AND HEALTH CARE BUILDINGS |
| 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 |
| CEI EN 60601-2-40 : 1999 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| BS EN ISO 11073-10425:2016 | Health informatics. Personal health device communication Device specialization. Continuous glucose monitor (CGM) |
| UNE-EN ISO 10650:2016 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
| NF EN ISO 11073-10406 : 2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
| ISO 7494-1:2011 | Dentistry Dental units Part 1: General requirements and test methods |
| EN ISO 7494-1:2011 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| ISO/TS 22595-2:2008 | Dentistry Plant area equipment Part 2: Compressor systems |
| I.S. EN ISO 10079-1:2015 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
| UNE-EN 62041:2011 | Safety of transformers, reactors, power supply units and combinations thereof - EMC requirements |
| I.S. EN ISO 16954:2015 | DENTISTRY - TEST METHODS FOR DENTAL UNIT WATERLINE BIOFILM TREATMENT (ISO 16954:2015) |
| 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) |
| NF EN 60601-2-68 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
| 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) |
| CSA CEI/IEC 1288.1 : 1998 | CARDIAC DEFIBRILLATORS - CARDIAC DEFIBRILLATORS-MONITORS - PART 1: OPERATION |
| CSA C22.2 No. 80601-2-56 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
| PD 6630:1998 | Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale |
| DIN EN 13976-1:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| 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 |
| DIN EN ISO 7494-1:2011-11 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
| IEEE 11073-10424-2014 | IEEE Standard - Health informatics--Personal health device communication - Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE) |
| ISO 10936-1:2017 | Optics and photonics — Operation microscopes — Part 1: Requirements and test methods |
| UNI EN ISO 15002 : 2008 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| GOST R ISO 7176-14 : 2012 | WHEELCHAIRS - PART 14: POWER AND CONTROL SYSTEMS FOR ELECTRIC WHEELCHAIRS AND SCOOTERS - REQUIREMENTS AND TEST METHODS |
| NF EN 60601-2-52 : 2010-06 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS |
| CSA CEI/IEC 1258 : 1998 | GUIDELINES FOR THE DEVELOPMENT AND USE OF MEDICAL ELECTRICAL EQUIPMENT EDUCATIONAL MATERIALS |
| XP ISO/TS 22595-2 : 2008 XP | DENTISTRY - PLANT AREA EQUIPMENT - PART 2: COMPRESSOR SYSTEMS |
| NF EN ISO 23328-2 : 2009 | BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS |
| CSA C22.2 No. 601.2.27 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
| ASTM F 1343 : 2002 | Standard Specification for Anesthetic Gas Scavenging Systems-Transfer and Receiving Systems (Withdrawn 2011) |
| ISO 10524-1:2018 | Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| EN ISO 14457:2017 | Dentistry - Handpieces and motors (ISO 14457:2017) |
| ISO 7176-25:2013 | Wheelchairs — Part 25: Batteries and chargers for powered wheelchairs |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN ISO 80601-2-56:2017 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017) |
| EN ISO 11073-10425:2016 | Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016) |
| I.S. EN ISO 5359:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| I.S. EN 13976-1:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| I.S. EN ISO 22374:2005 | DENTISTRY - DENTAL HANDPIECES - ELECTRICAL-POWERED SCALERS AND SCALER TIPS |
| I.S. EN ISO 20072:2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| I.S. EN 60601-2-9:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| I.S. EN 62464-1:2007 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS |
| ISO 14457:2017 | Dentistry — Handpieces and motors |
| 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 60601-2-51:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
| 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) |
| BS EN ISO 80601-2-13:2012+A2:2019 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| 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 |
| EN 60601-2-33:2010/A12:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| IEC 60522:1976 | Inherent filtration of an X-ray tube assembly |
| DIN EN ISO 10940:2010-01 | Ophthalmic instruments - Fundus cameras (ISO 10940:2009) |
| DIN EN ISO 10341:2013-04 | Ophthalmic instruments - Refractor heads (ISO 10341:2012) |
| DIN EN ISO 10939:2016-10 (Draft) | OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017) |
| DIN EN ISO 10535:2007-04 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| DIN EN ISO 11252:2014-02 | LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION (ISO 11252:2013) |
| DIN EN ISO 10943:2011-11 | Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011) |
| DIN EN ISO 10343:2014-10 | OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014) |
| DIN EN 957-6:2014-06 | STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS |
| IEC 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| BS EN ISO 10942:2006 | Ophthalmic instruments. Direct ophthalmoscopes |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| BS EN ISO 17510-2:2009 | Sleep apnoea breathing therapy Masks and application accessories |
| UNE-EN ISO 15001:2012 | Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
| IEC 60601-2-4:2010+AMD1:2018 CSV | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| IEC 61168:1993 | Radiotherapy simulators - Functional performance characteristics |
| BS EN 12312-14:2014 | Aircraft ground support equipment. Specific requirements Disabled/incapacitated passenger boarding vehicles |
| EN 60601-2-66:2015 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
| ISO 15752:2010 | Ophthalmic instruments Endoilluminators Fundamental requirements and test methods for optical radiation safety |
| ISO 81060-1:2007 | Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type |
| ISO 13294:1997 | Dental handpieces Dental air-motors |
| IEC 61689:2013 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
| BS EN ISO 10944:2009 | Ophthalmic instruments. Synoptophores |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| IEC 62467-1:2009 | Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers |
| BS EN ISO 21647:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| BS EN ISO 18779:2005 | Medical devices for conserving oxygen and oxygen mixtures. Particular requirements |
| BS EN ISO 19980:2012 | Ophthalmic instruments. Corneal topographers |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| IEC 61558-2-16:2009+AMD1:2013 CSV | Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1 100 V - Part 2-16: Particularrequirements and tests for switch mode power supply units andtransformers for switch mode power supply units |
| ISO 10343:2014 | Ophthalmic instruments — Ophthalmometers |
| BS EN ISO 8835-5:2009 | Inhalational anaesthesia systems Anaesthesia ventilators |
| BS EN ISO 18777:2009 | Transportable liquid oxygen systems for medical use. Particular requirements |
| BS EN ISO 8835-4:2009 | Inhalational anaesthesia systems Anaesthetic vapour delivery devices |
| BS EN ISO 10943:2011 | Ophthalmic instruments. Indirect ophthalmoscopes |
| IEC 60601-2-51:2003 | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| BS EN ISO 15004-1:2009 | Ophthalmic instruments. Fundamental requirements and test methods General requirements applicable to all ophthalmic instruments |
| ISO 19980:2012 | Ophthalmic instruments Corneal topographers |
| DIN EN ISO 18779:2005-06 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
| AAMI SP10 : 2002 | MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS |
| 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 |
| EN 61223-2-6:2007 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
| EN 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| HD 60364-7-710:2012/AC:2013 | LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS |
| DIN EN ISO 8612:2010-02 | Ophthalmic instruments - Tonometers (ISO 8612:2009) |
| EN 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| EN ISO 11196 : 1997 | ANAESTHETIC GAS MONITORS |
| DIN EN ISO 9360-1:2009-09 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
| EN 62464-1:2007 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| EN ISO 81060-1:2012 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
| EN 61223-3-2:2008 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| EN 61331-3:2014 | Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields |
| EN 12470-5:2003 | Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
| EN 60601-2-38:1996/A1:2000 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
| EN 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| EN 61910-1:2014 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| EN ISO 11252:2013 | Lasers and laser-related equipment - Laser device - Minimum requirements for documentation (ISO 11252:2013) |
| EN 60789:2005 | Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras |
| EN 60976:2007 | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| EN 61266:1995 | Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting |
| DIN EN 13976-1:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| EN 60601-2-24:2015 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| EN 60601-2-30:2000 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| DIN EN ISO 8185:2009-07 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| NF EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| EN 62083:2009 | MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
| EN 60601-2-32:1994 | Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment |
| EN 61223-3-4 : 2000 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-4: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF DENTAL X-RAY EQUIPMENT |
| EN 62041:2010 | Safety of transformers, reactors, power supply units and combinations thereof - EMC requirements |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN 12312-14:2014 | Aircraft ground support equipment - Specific requirements - Part 14: Disabled/incapacitated passenger boarding vehicles |
| EN 61675-2:2015 | Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging |
| EN ISO 10535:2006 | Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
| EN 60601-2-13 : 2006 AMD 1 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| NF EN 60580 : 2004 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
| EN 61674:2013 | Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| DIN EN ISO 10939:2017-09 | OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017) |
| EN 60601-2-37:2008/A1:2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| EN 60417-1:2002 | GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: OVERVIEW AND APPLICATION |
| EN 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| EN 80001-1:2011 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| EN 61267:2006 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
| EN 60731:2012 | Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| EN ISO 21969:2009 | High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
| EN 60598-2-25 : 1994 AMD 1 2004 | LUMINAIRES - PART 2-25: PARTICULAR REQUIREMENTS - LUMINAIRES FOR USE IN CLINICAL AREAS OF HOSPITALS AND HEALTH CARE BUILDINGS |
| EN 61331-2:2014 | Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates |
| EN 60335-2-69:2012 | Household and similar electrical appliances - Safety - Part 2-69: Particular requirements for wet and dry vacuum cleaners, including power brush for commercial use |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| EN 60601-2-36:2015 | Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
| EN 60601-2-17:2015 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
| EN 60645-1:2017 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
| 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) |
| EN 60645-6:2010 | Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
| EN 60601-2-54:2009/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
| CSA C22.2 No. 60601.2.26 : 2014(R2018) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIS SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS |
| UNE-EN 957-6:2011 | Stationary training equipment - Part 6: Treadmills, additional specific safety requirements and test methods |
| CSA Z9360.1 : 2007 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML |
| CSA Z10651-5 : 2008 : R2018 | Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators |
| UNE-EN 60601-1-3:2008 | Medical electrical equipment- Part 1-3: General requirements for basic safety and essential performance- Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| 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. 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 Z9360.1 : 2007 : R2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML |
| 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 |
| 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 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 |
| ASME PVHO 1 : 2016 | SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| IEC 60112:2003+AMD1:2009 CSV | Method for the determination of the proof and the comparative tracking indices of solid insulating materials |
| IEC 60320-1:2015 | Appliance couplers for household and similar general purposes - Part 1: General requirements |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 61672-2:2013+AMD1:2017 CSV | Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| IEC 61558-2-1:2007 | Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications |
| IEC 60245-1:2003+AMD1:2007 CSV | Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| IEC TS 60479-1:2005+AMD1:2016 CSV | Effects of current on human beings and livestock - Part 1: Generalaspects |
| IEC 60384-14:2013+AMD1:2016 CSV | Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains |
| UL 1439:5ED 2015-04-21 | Tests for Sharpness of Edges on Equipment |
| IEC 60364-7-710:2002 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations |
| IEC 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| IEC 60050-195:1998 | International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock |
| IEC 60364-4-41:2005+AMD1:2017 CSV | Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock |
| IEC 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
| IEC 61558-2-4:2009 | Safety of transformers, reactors, power supply units and similar products for supply voltages up to 1 100 V - Part 2-4: Particular requirements and tests for isolating transformers and power supply units incorporating isolating transformers |
| IEC TR 62354:2014 | General testing procedures for medical electrical equipment |
| ISO 23529:2016 | Rubber General procedures for preparing and conditioning test pieces for physical test methods |
| ISO 2882:1979 | Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits |
| ISO 9614-1:1993 | Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points |
| IEC 60050-151:2001 | International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| IEC 61000-4-11:2004+AMD1:2017 CSV | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
| IEC 60050-441:1984 | International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| 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 |
| IEC 60332-2-2:2004 | Tests on electric and optical fibre cables under fire conditions - Part 2-2: Test for vertical flame propagation for a single small insulated wire or cable - Procedure for diffusion flame |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| IEC 61558-2-23:2010 | Safety of transformers, reactors, power supply units and combinations thereof - Part 2-23: Particular requirements and tests for transformers and power supply units for construction sites |
| 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 |
| IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV | Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links |
| IEC 60851-6:2012 | Winding wires - Test methods - Part 6: Thermal properties |
| IEC 60079-5:2015 RLV | Explosive atmospheres - Part 5: Equipment protection by powder filling "q" |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60851-5:2008+AMD1:2011 CSV | Winding wires - Test methods - Part 5: Electrical properties |
| IEC 60227-1:2007 | Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements |
| IEC 60332-1-2:2004+AMD1:2015 CSV | Tests on electric and optical fibre cables under fire conditions - Part 1-2: Test for vertical flame propagation for a single insulatedwire or cable - Procedure for 1 kW pre-mixed flame |
| 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 |
| EN 563:1994/A1:1999/AC:2000 | SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES |
| IEC 60601-2-4:2010 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| 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 |
| IEC 60085:2007 | Electrical insulation - Thermal evaluation and designation |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 61558-1:2017 | Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| IEC 60447:2004 | Basic and safety principles for man-machine interface, marking and identification - Actuating principles |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 780:2015 | Packaging Distribution packaging Graphical symbols for handling and storage of packages |
| 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 |
| MIL-HDBK-217 Revision F:1991 | RELIABILITY PREDICTION OF ELECTRONIC EQUIPMENT |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 61058-1:2016 | Switches for appliances - Part 1: General requirements |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| IEC 60068-2-2:2007 | Environmental testing - Part 2-2: Tests - Test B: Dry heat |
| IEC 60695-11-10:2013 | Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60079-6:2015 | Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" |
| IEC 60079-0:2011 | Explosive atmospheres - Part 0: Equipment - General requirements |
| ISO 8041:2005 | Human response to vibration Measuring instrumentation |
| IEC 60851-3:2009+AMD1:2013 CSV | Winding wires - Test methods - Part 3: Mechanical properties |
| IEC 62079:2001 | Preparation of instructions - Structuring, content and presentation |
| ISO 80000-1:2009 | Quantities and units — Part 1: General |
| ISO 13857:2008 | Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs |
| ISO 2878:2017 | Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance |
| IEC 60086-1:2015 | Primary batteries - Part 1: General |
| IEC 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| ISO 3864-1:2011 | Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings |
| IEC 60252-1:2010+AMD1:2013 CSV | AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation |
| ISO 407:2004 | Small medical gas cylinders Pin-index yoke-type valve connections |
| IEC 60050-826:2004 | International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations |
| IEC 61965:2003 | Mechanical safety of cathode ray tubes |
| ISO 5349-1:2001 | Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60086-4:2014 | Primary batteries - Part 4: Safety of lithium batteries |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| IEC 60317-43:1997+AMD1:2010 CSV | Specifications for particular types of winding wires - Part 43: Aromatic polyimide type wrapped round copper wire, class 240 |
| IEC 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| ISO 1853:2011 | Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity |
| IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV | Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60695-1-10:2016 | Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines |
| IEC 60445:2017 | Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors |
| IEC 60664-1:2007 | Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| IEC 60990:2016 | Methods of measurement of touch current and protective conductor current |
| 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 5805:1997 | Mechanical vibration and shock — Human exposure — Vocabulary |
| IEC 60730-1:2013+AMD1:2015 CSV | Automatic electrical controls - Part 1: General requirements |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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