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Database: 365,228(8 Aug 2026)
  1. HOME
  2. Standards for Correction of medical devices

Correction of medical devices

Correction of medical devices, Total:491 items.

The international standard classification for "Correction of medical devices" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "Correction of medical devices" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices .

Guangdong Provincial Standard of the People's Republic of China

  • DB4420/T 45-2024 Specifications for registration management of Class I medical device products

Professional Standard - Medicine

  • YY/T 0316-2008 Medical devices - Application of risk management to medical devices
  • YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
  • YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
  • YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
  • YY/T 0316-2016 Medical devices-Application of risk management to medical devices
  • YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
  • YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
  • YY/T 1474-2016 Medical devices－Application of risk management to medical devices
  • YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

  • GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
  • GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Group Standards of the People's Republic of China

  • T/ZGXX 0003-2019 Medical device cleaning agent
  • T/GDMDMA 0012.9-2022 Specifications for the Management of Medical Equipment in Hospitals - Part 9: Maintenance and Repair Management

Swedish Institute for Standards

  • SS-EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • SS-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • SS-EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
  • SS-EN 556-2:2024 Sterilization of medical devices — Requirements for medical devices to be designated ''STERILE" — Part 2: requirements for aseptically processed medical devices
  • SS-EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • SS-EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • SS-EN 556-1:2024 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
  • SS-EN 62366-1:2016 Medical devices - Part 1: Application of usability engineering to medical devices

European Committee for Standardization (CEN)

  • EN 980:1996/PRA2:1996 Graphical Symbols for Use in the Labelling of Medical Devices Amendment PRA2
  • EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
  • EN 980:1996/A1:1996 AMD A1 Graphical Symbols for Use in the Labelling of Medical Devices Includes Amendment A1:1999
  • EN ISO 10993-17:2023/FprA1 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/FDAM 1:2025)
  • EN ISO 10993-17:2023/prA1 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
  • EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
  • EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
  • EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
  • EN 552:1994/A1:1999 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
  • EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

European Union/Commission

American National Standards Institute （ANSI)

  • ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
  • ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
  • ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
  • ANSI/AAMI/ISO 17664-2:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
  • ANSI/AAMI/ISO 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices

International Organization for Standardization (ISO)

  • ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
  • ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
  • ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
  • ISO 14971:2019 Medical devices — Application of risk management to medical devices
  • ISO 14971:2000 Medical devices - Application of risk management to medical devices
  • ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
  • ISO 10993-12:2021/Amd 1:2025 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
  • ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • ISO 15223-1:2007/Amd 1:2008 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1
  • ISO 9626:1991/Amd 1:2001 Stainless steel needle tubing for the manufacture of medical devices; Amendment 1

German Institute for Standardization

International Electrotechnical Commission (IEC)

  • IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices — Amendment 1
  • IEC 62366-1:2015/AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
  • IEC 62366-1:2015/AMD 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
  • IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
  • IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
  • IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices

Standards Norway

  • NS-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • NS-EN ISO 14971:2012 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
  • NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
  • SN-CR 14060:2000 Medical device traceability
  • NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
  • NS-EN ISO 17664-2:2023 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
  • NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
  • NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
  • NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
  • NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
  • NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
  • NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
  • NS-EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

Lithuanian Standards Office

  • LST EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
  • LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)

Spanish Association for Standardization (UNE)

  • UNE-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • UNE-EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
  • AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
  • UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • 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
  • AENOR 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
  • UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
  • AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
  • UNE-EN ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
  • UNE-EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)

Gosstandart of Russia

  • GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
  • GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
  • GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
  • GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
  • GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
  • GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software

GCC Standardization Organization

  • BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
  • OS GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
  • GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure

Japanese Industrial Standards Committee (JISC)

  • JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
  • JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
  • JIS T 14971:2020 Medical devices -- Application of risk management to medical devices
  • JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 17664-2-2022 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
  • KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
  • KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • KS P ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • KS P IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
  • KS P IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
  • KS P IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
  • KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices

British Standards Institution (BSI)

  • BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
  • BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
  • BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
  • BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
  • BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • BS EN 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
  • 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 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
  • BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
  • BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
  • BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
  • BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
  • PD IEC/TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
  • PD ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
  • BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents

Austrian Standards

  • OENORM EN ISO 10993-18/A1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020/DAM 1:2021) (Amendment)
  • OENORM EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2021)

Ente Nazionale Italiano di Unificazione

  • UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
  • EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2022 Medical devices - Application of risk management to medical devices
  • UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
  • UNI EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
  • UNI CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • UNI EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
  • UNI EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
  • UNI EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • UNI EN 556:1996 Sterilization of medical devices. Requirements for medical devices to be labelled "Sterile".

South African Bureau of Standard

  • SANS 14971:2008 Medical devices - Application of risk management to medical devices

Association Francaise de Normalisation

  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
  • NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
  • NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to obtain STERILE labeling - Part 1: Requirements for terminally sterilized medical devices
  • NF S98-107-2*NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
  • NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
  • NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer
  • NF EN ISO 25424/A1:2022 Sterilization of healthcare products - Formaldehyde and low temperature steam - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1
  • NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
  • NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
  • NF EN ISO 19054/A1:2017 Support rail systems for medical devices - Amendment 1
  • NF EN ISO 11135/A1:2019 Sterilization of healthcare products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: revision of Annex E, Release ...
  • NF S98-107-1*NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to obtain the "STERILE" label - Part 2: Requirements for medical devices subject to aseptic processing
  • NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
  • NF S99-501-4/A1*NF EN ISO 10993-4/A1:2025 Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood - Amendment 1

Thai Industrial Standards Institute (TISI)

  • TIS 14971-2013 Medical devices.application of risk management to medical devices

Canadian Standards Association (CSA)

  • CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
  • CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
  • CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
  • CSA ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • CAN/CSA-ISO 17664-2-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
  • CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
  • CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
  • CAN/CSA-ISO 17664-1-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)

Comitato Elettrotecnico Italiano

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
  • BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
  • BH GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

Association for the Advancement of Medical Instrumentation

  • AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
  • AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
  • AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
  • AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
  • AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • AAMI/ISO 17664-2:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
  • AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
  • AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
  • AAMI/ISO 15223-2000 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied - Includes Amendment 1, dated September 24, 2001

Danish Standards Foundation

  • DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
  • DS/EN ISO 7405/A1:2013 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material
  • DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
  • DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
  • DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
  • DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • DANSK DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
  • DS/CEN/CR 14060:2001 Medical device traceability
  • DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
  • DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • DANSK DS/EN ISO 17664-2:2024 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)
  • DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/ISO/TS 19218-1/Amd 1:2013 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes - AMENDMENT 1
  • DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
  • DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
  • DS/EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • DANSK DS/EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
  • DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

Association of German Mechanical Engineers

Standard Association of Australia （SAA）

  • AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

The Directorate General of Specifications and Metrology (DGSM)

European Committee for Electrotechnical Standardization（CENELEC）

  • EN 62366:2008 Medical devices - Application of usability engineering to medical devices

Military Standards (MIL-STD)

Bureau of Indian Standards

  • IS 18742-2-2024 Processing of Health Care Products - Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices - Part 2 Non-Critical Medical Devices
  • IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision
  • IS 18742-1-2024 Processing of Health Care Products-Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices - Part 1 Critical and Semi-Critical Medical Devices
  • IS/ISO 15223-1-2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part — General Requirements ( Second Revision )
  • IS/ISO/TR 80002-2-2017 Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems
  • IS/IEC 62366-1-2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices
  • IS/ISO 17664-2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

Australian/New Zealand Standard (AU-AS/NZS)

  • AS/NZS 2696:1996 Medical Devices - Polymer Urethral Catheters for General Medical Use (Amendment 1 March 1999)

Indonesia Standards

  • SNI ISO 14971:2019 Healthcare Devices – Application of Risk Management to Healthcare Devices (ISO 14971:2019, IDT)
  • SNI ISO 17664-2:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 2: Alat kesehatan non-kritikal (ISO 17664-2:2021, IDT)
  • SNI ISO 17664-1:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 1: Alat kesehatan kritikal dan semi kritikal (ISO 17664-1:2021, IDT)
  • SNI ISO 14971:2015 Alat kesehatan - Penerapan manajemen risiko pada alat kesehatan (ISO 14971:2007, IDT)

US Federal Contractor Registration (USFCR)

Polski Komitet Normalizacyjny (PKN)

Swiss Association for Standardization (SNV)

  • SN EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

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