ISO 17664:2017
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
06-07-2021
Superseded by
Language(s)
English, French
Published date
25-10-2017
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.
This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.
| DevelopmentNote |
Supersedes ISO/DIS 17664. (10/2017)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 17664:2018-04 | Identical |
| I.S. EN ISO 17664:2004 | Identical |
| NS EN ISO 17664 : 2017 | Identical |
| UNE-EN ISO 17664:2018 | Identical |
| PN EN ISO 17664 : 2018 | Identical |
| UNI EN ISO 17664:2018 | Identical |
| NF EN ISO 17664 : 2017 | Identical |
| BS EN ISO 17664:2017 | Identical |
| EN ISO 17664:2017 | Identical |
| NEN EN ISO 17664 : 2018 | Identical |
| SN EN ISO 17664 : 2018 | Identical |
| ONORM EN ISO 17664 : 2018 | Identical |
| DIN EN ISO 17664:2016-06 (Draft) | Identical |
| SS-EN ISO 17664:2017 | Identical |
| ANSI/AAMI/ISO 17664:2017 | Identical |
| UNI EN ISO 17664 : 2005 | Identical |
| CSA Z17664 : 2006 : R2011 | Identical |
| CSA Z17664 : 2006 | Identical |
| CSA Z17664 : 2006 (R2016) | Identical |
| UNE-EN ISO 17664:2004 | Identical |
| GOST R ISO 17664 : 2012 | Identical |
| NBN EN ISO 17664 : 2004 | Identical |
| I.S. EN ISO 17664:2017 | Identical |
| DIN EN ISO 11953:2010-11 | Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010), German version EN ISO 11953:2010 |
| DIN EN ISO 21672-1:2012-07 | Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012) |
| I.S. EN 1041:2008+A1:2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| I.S. EN ISO 11953:2010 | DENTISTRY - IMPLANTS - CLINICAL PERFORMANCE OF HAND TORQUE INSTRUMENTS |
| NF EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| 14/30261090 DC : 0 | BS EN ISO 17937 - DENTISTRY - OSTEOTOME FOR BONE COMPACTION AND SINUS FLOOR ELEVATION |
| DIN EN ISO 3630-4:2009-10 | Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009) |
| BS EN ISO 13504:2012 | Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment |
| I.S. EN 15424:2007 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 15/30328959 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 12/30261215 DC : 0 | BS EN 13060 - SMALL STEAM STERILIZERS |
| 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 ISO 21672-1:2012 | Dentistry. Periodontal probes General requirements |
| 09/30203808 DC : 0 | BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| 16/30310674 DC : 0 | BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS |
| 16/30297742 DC : DRAFT JUNE 2016 | BS EN ISO 19490 - DENTISTRY - SINUS MEMBRANE ELEVATOR |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| I.S. EN ISO 18397:2016 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
| DD CEN ISO/TS 11135-2:2008 | Sterilization of health care products. Ethylene oxide Guidance on the application of ISO 11135-1 |
| UNE-EN ISO 19490:2018 | Dentistry - Sinus membrane elevator (ISO 19490:2017) |
| 15/30314608 DC : 0 | BS EN ISO 7153-1 - SURGICAL INSTRUMENTS - MATERIALS - PART 1: METALS |
| 16/30302541 DC : 0 | BS EN ISO 19715 - DENTISTRY - FILLING INSTRUMENTS WITH CONTRA SET |
| 15/30297745 DC : 0 | BS EN ISO 9173-1 - DENTISTRY - EXTRACTION FORCEPS - PART 1: GENERAL REQUIREMENTS |
| 10/30205392 DC : 0 | BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 11135:2014-10 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| 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 |
| 07/30157980 DC : 0 | BS EN 60601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| CSA Z11135-2 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| CSA Z17665-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| 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 |
| CAN/CSA-C22.2 NO. 80601-2-67:17 | Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations) |
| CSA ISO 14937 : 2011 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| DIN EN ISO 11135-1:2007-08 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| PREN 13060 : DRAFT 2012 | SMALL STEAM STERILIZERS |
| DIN EN ISO 18397:2016-09 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
| ANSI/AAMI/ISO 14937:2009(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 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) |
| AAMI/ISO TIR17665-3:2014(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| ANSI/AAMI/ISO 11135:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
| CSA C22.2 No. 80601-2-55 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
| I.S. EN ISO 21672-1:2012 | DENTISTRY - PERIODONTAL PROBES - PART 1: GENERAL REQUIREMENTS (ISO 21672-1:2012) |
| I.S. EN 15546-1:2008 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 18556:2016 | DENTISTRY - INTRAORAL SPATULAS (ISO 18556:2016) |
| 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 Z17665-1 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNE-EN ISO 22442-1:2016 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| UNI EN ISO 7494-1 : 2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| UNE-EN ISO 16635-2:2015 | Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014) |
| ISO 80601-2-74:2017 | Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| DIN EN ISO 22442-1:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| DIN EN ISO 15883-2:2009-09 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| ISO 15883-2:2006 | Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 7153-1:2016 | Surgical instruments. Materials Metals |
| BS EN 15424:2007 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 14630:2012 | Non-active surgical implants. General requirements |
| EN 80601-2-58:2015 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| DIN EN 15424:2007-08 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| VDI 5700 Blatt 1:2015-04 | Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
| BS ISO 19611:2017 | Traditional Chinese medicine. Air extraction cupping device |
| UNI EN ISO 16635-2 : 2014 | DENTISTRY - DENTAL RUBBER DAM INSTRUMENTS - PART 2: CLAMP FORCEPS |
| BS EN ISO 16635-2:2014 | Dentistry. Dental rubber dam instruments Clamp forceps |
| 12/30245297 DC : 0 | BS EN ISO 16635-2 - DENTISTRY - RUBBER DAM TECHNIQUE - PART 2: RUBBER DAM CLAMP FORCEPS |
| BS EN ISO 20857:2013 | Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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 |
| DIN EN ISO 9168:2009-10 | DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| 15/30278527 DC : 0 | BS EN ISO 18559 - DENTISTRY - EXTRAORAL SPATULAS FOR MIXING DENTAL CEMENTS |
| UNE-EN ISO 13504:2013 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012) |
| BS EN ISO 19490:2017 | Dentistry. Sinus membrane elevator |
| DIN EN 15546-1:2008-08 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 80601-2-72:2016-04 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
| BS EN ISO 19715:2017 | Dentistry. Filling instrument with contra angle |
| PD ISO/TS 17665-3:2013 | Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| ISO 20308:2017 | Traditional Chinese medicine — Gua Sha instruments |
| 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 |
| 11/30212235 DC : 0 | BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
| 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 |
| 11/30212226 DC : 0 | BS ISO 21672-1 - DENTISTRY - PERIODONTAL PROBES - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 17937:2016-01 | Dentistry - Osteotome (ISO 17937:2015) |
| DIN EN ISO 22374:2005-12 | DENTISTRY - DENTAL HANDPIECES - ELECTRICAL-POWERED SCALERS AND SCALER TIPS |
| NF CEN ISO/TS 11135-2 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| 04/30048205 DC : DRAFT JUL 2004 | BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 09/30180393 DC : 0 | BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| UNE-EN ISO 18556:2016 | Dentistry - Intraoral spatulas (ISO 18556:2016) |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 16/30302520 DC : 0 | BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE |
| 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) |
| AAMI ISO 17665-1 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN ISO 17937:2015 | DENTISTRY - OSTEOTOME (ISO 17937:2015) |
| ANSI/AAMI/ISO 20857:2010(R2015) | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNI CEN ISO/TS 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| ISO 19979:2018 | Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses |
| I.S. EN 80601-2-60:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
| ISO 8828:2014 | Implants for surgery Guidance on care and handling of orthopaedic implants |
| UNE-EN ISO 11135:2015 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| AAMI ISO TIR 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| I.S. EN ISO 14457:2017 | DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017) |
| ANSI/AAMI/IEC 80601-2-58:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| UNE-EN ISO 7494-1:2012 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| I.S. EN 13060:2014 | SMALL STEAM STERILIZERS |
| CSA C22.2 No. 80601-2-60 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| CEI UNI EN 1041 : 2014 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| CSA Z17665-2:09 (R2019) | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
| ISO 9873:2017 | Dentistry Intra-oral mirrors |
| DIN EN ISO 19715:2016-03 (Draft) | DENTISTRY - FILLING INSTRUMENT WITH CONTRA ANGLE (ISO 19715:2017) |
| CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| I.S. EN ISO 9873:2017 | DENTISTRY - INTRA-ORAL MIRRORS (ISO 9873:2017) |
| UNE-EN ISO 14457:2013 | Dentistry - Handpieces and motors (ISO 14457:2012) |
| NF EN ISO 11953 : 2010 | DENTISTRY - IMPLANTS - CLINICAL PERFORMANCE OF HAND TORQUE INSTRUMENTS |
| I.S. EN ISO 16635-2:2014 | DENTISTRY - DENTAL RUBBER DAM INSTRUMENTS - PART 2: CLAMP FORCEPS (ISO 16635-2:2014) |
| UNI EN ISO 11135 : 2014 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| DIN EN 1639:2010-02 | Dentistry - Medical devices for dentistry - Instruments |
| DIN EN ISO 6875:2011-10 | DENTISTRY - PATIENT CHAIR |
| DIN EN 556-2:2015-11 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| DIN EN 1041:2013-12 | Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
| DIN EN ISO 17665-1:2006-11 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| DIN EN ISO 17510-2:2009-07 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| DIN EN 1640:2010-02 | Dentistry - Medical devices for dentistry - Equipment |
| DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| BS EN 556-2:2015 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices |
| BS EN ISO 15883-2:2009 | Washer-disinfectors Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
| BS EN 1640:2009 | Dentistry. Medical devices for dentistry. Equipment |
| BS EN 1639:2009 | Dentistry. Medical devices for dentistry. Instruments |
| BS EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Application of risk management |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| I.S. EN ISO 6875:2011 | DENTISTRY - PATIENT CHAIR |
| I.S. EN ISO 7153-1:2016 | SURGICAL INSTRUMENTS - MATERIALS - PART 1: METALS (ISO 7153-1:2016) |
| I.S. EN ISO 15883-2:2009 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| I.S. EN ISO 14937:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| I.S. EN ISO 17510-2:2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| I.S. EN ISO 22442-1:2015 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
| I.S. EN 1639:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| I.S. EN 1640:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| I.S. EN ISO 9173-1:2016 | DENTISTRY - EXTRACTION FORCEPS - PART 1: GENERAL REQUIREMENTS (ISO 9173-1:2016) |
| I.S. EN ISO 10451:2010 | DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| I.S. EN ISO 14630:2012 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| VDI 2083 Blatt 13.2:2009-01 | Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications |
| VDI 2083 Blatt 13.1:2009-01 | Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals |
| 04/30048118 DC : DRAFT MAY 2004 | BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 14/30278521 DC : 0 | BS EN ISO 18556 - DENTISTRY - INTRAORAL SPATULAS |
| 13/30242570 DC : 0 | BS ISO 8828 - IMPLANTS FOR SURGERY - GUIDANCE ON CARE AND HANDLING OF ORTHOPAEDIC IMPLANTS |
| 13/30285624 DC : 0 | BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 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 |
| 11/30215841 DC : 0 | BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS |
| I.S. EN ISO 17665-1:2006 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 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 EN ISO 3630-4:2009 | Dentistry. Root canal instruments Auxiliary instruments |
| DIN EN ISO 18556:2016-09 | DENTISTRY - INTRAORAL SPATULAS (ISO 18556:2016) |
| NF 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 |
| 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 |
| 09/30193875 DC : DRAFT JAN 2009 | BS EN ISO 11953 - DENTISTRY - THE PERFORMANCE OF HAND TORQUE INSTRUMENTS FOR THE CLINICAL TIGHTENING OF SCREW-RETAINED JOINTS IN ENDOSSEOUS DENTAL IMPLANT SYSTEMS |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| UNI EN ISO 25424 : 2011 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 04/300654 DC : DRAFT JAN 2004 | BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL 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 |
| UNE-EN ISO 9168:2010 | Dentistry - Hose connectors for air driven dental handpieces (ISO 9168:2009) |
| BS ISO 10651-5:2006 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators |
| 17/30338806 DC : 0 | BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNI EN ISO 11953 : 2010 | DENTISTRY - IMPLANTS - CLINICAL PERFORMANCE OF HAND TORQUE INSTRUMENTS |
| BS EN 15546-1:2008 | Small bore connectors for liquids and gases in healthcare applications General requirements |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| I.S. EN ISO 19490:2017 | DENTISTRY - SINUS MEMBRANE ELEVATOR (ISO 19490:2017) |
| BS EN ISO 11135:2014 | Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices |
| CSA Z11135-1 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ANSI/AAMI/ISO 22442-1:2016 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
| ISO 18397:2016 | Dentistry Powered scaler |
| AAMI ST15883-2 : 2013 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| CSA Z17665-1:09 (R2019) | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations) |
| DIN EN ISO 19490:2016-07 (Draft) | DENTISTRY - SINUS MEMBRANE ELEVATOR (ISO 19490:2017) |
| I.S. EN ISO 20608:2018 | DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018) |
| EN 13060:2014 | Small steam sterilizers |
| ANSI/AAMI ISO 17665-1:2006(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI ISO 14937:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNI CEN ISO/TS 11135-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| CSA Z17665-1 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN ISO 25424:2011 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| AAMI ISO 11135-1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN 80601-2-58:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| OVE/ONORM 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 80601-2-55:2011) |
| I.S. EN ISO 13504:2012 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
| 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) |
| I.S. EN ISO 7492:2018 | DENTISTRY - DENTAL EXPLORER (ISO 7492:2018) |
| ISO 22374:2005 | Dentistry Dental handpieces Electrical-powered scalers and scaler tips |
| ISO 7492:2018 | Dentistry — Dental explorer |
| DIN EN 13060:2015-03 | SMALL STEAM STERILIZERS |
| ISO 80601-2-69:2014 | Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| ISO 9173-1:2016 | Dentistry — Extraction forceps — Part 1: General requirements |
| EN ISO 80601-2-69:2014 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| EN ISO 9173-1:2016 | Dentistry - Extraction forceps - Part 1: General requirements (ISO 9173-1:2016) |
| EN ISO 17937:2015 | Dentistry - Osteotome (ISO 17937:2015) |
| UNI EN ISO 6875 : 2011 | DENTISTRY - PATIENT CHAIR |
| UNI EN 1640 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| UNI EN ISO 10451 : 2010 | DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| UNI EN 1639 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| UNI EN ISO 17510-2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| UNI EN ISO 15883-2 : 2009 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| UNI EN ISO 14937 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| EN 15546-1:2008 | Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements |
| UNI EN ISO 14630 : 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| UNI CEI EN 15546-1 : 2009 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| UNI EN ISO 9168 : 2009 | DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES |
| DIN EN ISO 25424:2011-09 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| DIN EN ISO 13504:2012-10 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
| 16/30302544 DC : 0 | BS EN ISO 9873 - DENTISTRY - INTRA-ORAL MIRRORS |
| 18/30372409 DC : DRAFT APR 2018 | BS EN ISO 3630-1 - DENTISTRY - ENDODONTIC INSTRUMENTS - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 9873:2016-03 (Draft) | DENTISTRY - INTRA-ORAL MIRRORS (ISO 9873:2017) |
| I.S. EN 556-2:2015 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| BS EN ISO 9168:2009 | Dentistry. Hose connectors for air driven dental handpieces |
| 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 |
| BS EN ISO 18397:2016 | Dentistry. Powered scaler |
| BS EN ISO 11953:2010 | Dentistry. Implants. Clinical performance of hand torque instruments |
| I.S. EN ISO 11135-1:2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNE-EN ISO 20857:2013 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| BS EN 80601-2-60:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental equipment |
| 08/30168843 DC : DRAFT MAR 2008 | BS EN ISO 9168 - DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES |
| UNE-EN ISO 3630-4:2010 | Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009) |
| CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
| UNI EN ISO 13504 : 2012 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
| UNI CEI EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| 04/30081258 DC : DRAFT MARCH 2004 | BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS |
| 17/30323194 DC : 0 | BS EN ISO 20569 - DENTISTRY - TREPHINE BURS |
| 08/30168812 DC : DRAFT FEB 2008 | BS ISO 3630-4 - DENTISTRY - ROOT CANAL INSTRUMENTS - PART 4: AUXILIARY INSTRUMENTS |
| 17/30323197 DC : 0 | BS EN ISO 20570 - DENTISTRY - ORAL SURGICAL SCALPEL HANDLE |
| BS ISO 20308:2017 | Traditional Chinese medicine. Gua Sha instruments |
| BS EN ISO 9873:2017 | Dentistry. Intra-oral mirrors |
| UNI EN ISO 21672-1 : 2012 | DENTISTRY - PERIODONTAL PROBES - PART 1: GENERAL REQUIREMENTS |
| 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 Z11135-1 :2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA Z11135-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| UNI EN ISO 20857 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA Z11135-1 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| DIN EN ISO 20857:2013-08 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| 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 ISO 11135:2014 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| I.S. EN ISO 7494-1:2011 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| BS EN ISO 7492:2018 | Dentistry. Dental explorer |
| AAMI/ISO TIR17665-2:2009(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| 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) |
| S.R. CEN ISO TS 11135-2:2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
| BS EN ISO 7494-1:2011 | Dentistry. Dental units General requirements and test methods |
| 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 |
| UNE-EN 13060:2015 | Small steam sterilizers |
| EN ISO 9873:2017 | Dentistry - Intra-oral mirrors (ISO 9873:2017) |
| ISO 80601-2-55:2018 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 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 |
| 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 ISO 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| ISO 10651-5:2006 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| UNE-EN ISO 6875:2012 | Dentistry - Patient chair (ISO 6875:2011) |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 13504:2012 | Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment |
| ISO 19715:2017 | Dentistry — Filling instrument with contra angle |
| BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
| UNE-EN 556-2:2016 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| ISO 3630-4:2009 | Dentistry — Root canal instruments — Part 4: Auxiliary instruments |
| ISO 17937:2015 | Dentistry Osteotome |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 17510-2:2007 | Sleep apnoea breathing therapy Part 2: Masks and application accessories |
| ISO 7153-1:2016 | Surgical instruments Materials Part 1: Metals |
| ISO 21672-1:2012 | Dentistry — Periodontal probes — Part 1: General requirements |
| IEC 80601-2-60:2012 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| UNE-EN ISO 7153-1:2017 | Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016) |
| IEC 80601-2-58:2014+AMD1:2016 CSV | Medical electrical equipment - Part 2-58: Particular requirementsfor the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| BS EN ISO 17665-1:2006 | Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| BS EN ISO 14937:2009 | Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 80601-2-72:2015 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| ANSI/AAMI ST15883-2:2013(R2015) (ISO 15883-2:2006 MOD) | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| UNE-EN 1041:2009 | Information supplied by the manufacturer of medical devices |
| ISO 16635-2:2014 | Dentistry Dental rubber dam instruments Part 2: Clamp forceps |
| EN 80601-2-60:2015 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| 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 |
| BS EN 13060 : 2014 | SMALL STEAM STERILIZERS |
| ISO 6875:2011 | Dentistry Patient chair |
| ISO 18556:2016 | Dentistry Intraoral spatulas |
| ISO 11953:2010 | Dentistry Implants Clinical performance of hand torque instruments |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| BS EN ISO 9173-1:2016 | Dentistry. Extraction forceps General requirements |
| BS EN 1041 : 2008 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| ISO 9168:2009 | Dentistry Hose connectors for air driven dental handpieces |
| BS EN ISO 6875:2011 | Dentistry. Patient chair |
| UNE-EN ISO 14937:2010 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| UNE-EN ISO 14630:2013 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| BS EN ISO 10451:2010 | Dentistry. Contents of technical file for dental implant systems |
| ISO 19490:2017 | Dentistry — Sinus membrane elevator |
| ISO 10451:2010 | Dentistry — Contents of technical file for dental implant systems |
| UNE-EN ISO 9873:2017 | Dentistry - Intra-oral mirrors (ISO 9873:2017) |
| EN 15424:2007 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
| EN ISO 18556:2016 | Dentistry - Intraoral spatulas (ISO 18556:2016) |
| EN ISO 11953:2010 | Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010) |
| EN ISO 7153-1:2016 | Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016) |
| EN ISO 9168:2009 | Dentistry - Hose connectors for air driven dental handpieces (ISO 9168:2009) |
| EN ISO 15883-2:2009 | Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) |
| EN ISO 19490:2017 | Dentistry - Sinus membrane elevator (ISO 19490:2017) |
| EN ISO 17510-2:2009 | Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) |
| EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| EN ISO 10451:2010 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| EN ISO 20857:2013 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| EN 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| EN ISO 16635-2:2014 | Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014) |
| EN ISO 19715:2017 | Dentistry - Filling instrument with contra angle (ISO 19715:2017) |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| EN ISO 21672-1:2012 | Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012) |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| EN ISO 18397:2016 | Dentistry - Powered scaler (ISO 18397:2016) |
| EN ISO 3630-4:2009 | Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009) |
| EN ISO 13504:2012 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012) |
| EN ISO 6875:2011 | Dentistry - Patient chair (ISO 6875:2011) |
| BS ISO 8828:2014 | Implants for surgery. Guidance on care and handling of orthopaedic implants |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| UNE-EN ISO 21672-1:2012 | Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012) |
| UNI EN ISO 3630-4 : 2009 | DENTISTRY - ROOT CANAL INSTRUMENTS - PART 4: AUXILIARY INSTRUMENTS |
| BS EN ISO 25424:2011 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| 13/30290370 DC : 0 | BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| 14/30273278 DC : 0 | BS EN ISO 18397 - DENTISTRY - POWERED SCALER |
| UNE-EN ISO 17937:2016 | Dentistry - Osteotome (ISO 17937:2015) |
| 17/30303088 DC : 0 | BS EN ISO 7492 - DENTISTRY - DENTAL EXPLORER |
| BS EN ISO 18556:2016 | Dentistry. Intraoral spatulas |
| 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 |
| 17/30326683 DC : DRAFT SEP 2017 | BS ISO 19979 - OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES |
| 13/30271473 DC : 0 | BS EN 80601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| DD CEN ISO/TS 17665-2:2009 | Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| 17/30332162 DC : 0 | BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| S.R. CEN ISO TS 17665-2:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| 07/30164697 DC : 0 | ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN ISO 17937:2015 | Dentistry. Osteotome |
| CSA Z11135 : 2015 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA Z11135-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| AAMI ISO 20857 : 2010 | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO 19611:2017 | Traditional Chinese medicine — Air extraction cupping device |
| CSA ISO 14937 : 2011 : R2016 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| EN ISO 11135:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| CSA Z15883-2 : 2009 : R2014 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| 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) |
| I.S. EN ISO 19715:2017 | DENTISTRY - FILLING INSTRUMENT WITH CONTRA ANGLE (ISO 19715:2017) |
| CSA C22.2 No. 80601-2-58 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| AAMI ISO TIR 17665-3:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| I.S. EN ISO 9168:2009 | DENTISTRY - HOSE CONNECTORS FOR AIR DRIVEN DENTAL HANDPIECES |
| I.S. EN ISO 3630-4:2009 | DENTISTRY - ROOT CANAL INSTRUMENTS - PART 4: AUXILIARY INSTRUMENTS |
| 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) |
| ISO 80601-2-67:2014 | Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
| I.S. EN ISO 20857:2013 | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
| ISO/TR 14283:2018 | Implants for surgery Essential principles of safety and performance |
| 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 Z15883-2 : 2009 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| EN ISO 7492:2018 | Dentistry - Dental explorer (ISO 7492:2018) |
| EN ISO 22374:2005 | Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips (ISO 22374:2005) |
| ISO 7494-1:2011 | Dentistry Dental units Part 1: General requirements and test methods |
| BS ISO 19979:2018 | Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses |
| EN ISO 7494-1:2011 | Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
| 17/30362728 DC : 0 | BS EN 17169 - TATTOOING - SAFE AND HYGIENIC PRACTICE |
| ISO 20608:2018 | Dentistry — Powder jet handpieces and powders |
| AAMI ISO TIR 11135-2 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1 |
| DIN EN ISO 7494-1:2011-11 | DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
| UNE-EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| EN ISO 14457:2017 | Dentistry - Handpieces and motors (ISO 14457:2017) |
| 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) |
| I.S. EN ISO 22374:2005 | DENTISTRY - DENTAL HANDPIECES - ELECTRICAL-POWERED SCALERS AND SCALER TIPS |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| I.S. EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| ISO 14457:2017 | Dentistry — Handpieces and motors |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| DIN EN ISO 9173-1:2015-02 (Draft) | DENTISTRY - EXTRACTION FORCEPS - PART 1: GENERAL REQUIREMENTS (ISO 9173-1:2016) |
| BS EN ISO 17510-2:2009 | Sleep apnoea breathing therapy Masks and application accessories |
| BS EN ISO 11135-1:2007 | Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| DIN EN ISO 9173-1:2017-03 | DENTISTRY - EXTRACTION FORCEPS - PART 1: GENERAL REQUIREMENTS (ISO 9173-1:2016) |
| DIN EN ISO 9873:2000-07 | DENTISTRY - INTRA-ORAL MIRRORS (ISO 9873:2017) |
| DIN EN ISO 14937:2010-03 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| EN 15546-1 : 2008 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| CSA Z10651-5 : 2008 : R2018 | Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators |
| CSA 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 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 |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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