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Database: 365,228(8 Aug 2026)
  1. HOME
  2. Standards for Degradation Methods for Medical Devices

Degradation Methods for Medical Devices

Degradation Methods for Medical Devices, Total:352 items.

The international standard classification for "Degradation Methods for Medical Devices" includes: Medical equipment in general , Laboratory medicine , Medical equipment , Sterilization and disinfection in general , Other medical equipment .

The Chinese standard classification for "Degradation Methods for Medical Devices" includes: Medical apparatus and devices in general , Public medical equipment .

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

  • GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramics
  • GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
  • GB/T 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products
  • GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
  • GB/T 42062-2022 Medical devices—Application of risk management to medical devices
  • GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys
  • GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
  • GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices

Professional Standard - Medicine

  • YY/T 91050-1999 Editorial method for design documents of medical device product
  • YY 91050-1999 How to prepare medical device product design documents
  • YY/T 1607-2018 Radiation sterilization of medical device—Method of dose setting
  • YY/T 0316-2016 Medical devices-Application of risk management to medical devices
  • YY/T 0316-2008 Medical devices - Application of risk management to medical devices
  • YY/T 1474-2016 Medical devices－Application of risk management to medical devices
  • YY/T 1911-2023 Test method of coagulation for medical devices
  • YY/T 0316-2003 Medical devices -- Application of risk management to medical devices

Taiwan Provincial Standard of the People's Republic of China

  • CNS 14393.13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Group Standards of the People's Republic of China

Gosstandart of Russia

  • 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 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 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
  • GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST R ISO 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
  • GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
  • GOST ISO 10993-9-2011 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
  • GOST ISO 10993-15-2011 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
  • GOST R ISO 10993-15-2001 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
  • GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
  • GOST R ISO 10993.13-1999 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices / Note: To be replaced by GOST R ISO 10993-13 (2009).
  • GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
  • GOST R ISO 10993-14-2009 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
  • 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 ISO 10993-9-2022 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
  • GOST R ISO 10993-9-2009 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
  • GOST R ISO 10993-15-2009 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
  • GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
  • GOST ISO 10993-15-2023 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
  • GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
  • GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
  • GOST R ISO 10993-16-2009 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
  • GOST R ISO 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
  • GOST ISO 10993-16-2021 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
  • GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
  • GOST R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices
  • GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure

British Standards Institution (BSI)

  • BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
  • BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
  • BS EN ISO 10993-13:1999 Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices
  • 08/30156451 DC BS EN ISO 10993-13. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • BS EN ISO 10993-14:2009 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
  • BS EN ISO 10993-9:1999 Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products
  • BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
  • BS EN ISO 10993-14:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
  • BS EN 29073-3:1992 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
  • BS EN ISO 10993-9:2009 Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products
  • BS 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
  • BS EN ISO 10993-9:2021 Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
  • BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices
  • BS EN ISO 10993-15:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys
  • BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
  • DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
  • BS 5736-10:1988 Evaluation of medical devices for biological hazards-Method of test for toxicity to cells in culture of extracts from medical devices
  • BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2009 Medical devices - Application of risk management 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 10993-16:2009 Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables
  • BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
  • BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • BS EN ISO 10993-16:2010 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
  • 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 ISO 10993-15:2023 Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys (British Standard)
  • 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 PD ISO/TS 23128:2019 Medical devices. Transfusion set and blood bag compatibility test method

German Institute for Standardization

Thai Industrial Standards Institute (TISI)

  • TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices
  • TIS 2395.14-2008 Biological evaluation of medical devices.part 14: identification and quantification of degradation products from ceramics
  • TIS 2395.9-2008 Biological evaluation of medical devices.part 9: framework for identification and quantification of potential degradation products
  • TIS 14971-2013 Medical devices.application of risk management to medical devices
  • TIS 2395.15-2008 Biological evaluation of medical devices.part 15: identification and quantification of degradation products from metals and alloys

Association Francaise de Normalisation

  • NF EN ISO 10993-13:2010 Biological assessment of medical devices - Part 13: identification and quantification of degradation products of polymer-based medical devices
  • NF S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
  • NF EN ISO 10993-14:2009 Biological assessment of medical devices - Part 14: identification and quantification of ceramic degradation products
  • NF S99-513:1999 Biological evaluation of medical devices. Part 13 : identification and quantification of degradation products from polymeric medical devices.
  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: framework for the identification and quantification of potential degradation products
  • NF S99-501-9*NF EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products
  • NF EN ISO 10993-15:2023 Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys
  • NF S99-501-15*NF EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys
  • NF EN ISO 10993-15:2009 Biological assessment of medical devices - Part 15: identification and quantification of degradation products from metals and alloys
  • 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 S99-211/A11*NF EN ISO 14971/A11:2021 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.

Ente Nazionale Italiano di Unificazione

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 10993-13-2018(2023) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
  • KS P ISO 10993-13-2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
  • KS P ISO 10993-13:2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
  • KS P ISO 10993-13:2007 Biological evaluation of medical devices － Part 13: Identification and quantification of degradation products from polymeric medical devices
  • KS P ISO 10993-13-2023 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
  • KS P ISO 10993-14-2022 Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
  • KS P ISO 10993-14-2017 Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
  • KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
  • KS P ISO 10993-14:2017 Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
  • KS P ISO 10993-14:2006 Biological evaluation of medical devices － Part 14: Identification and quantification of degradation products from ceramics
  • KS P ISO 10993-14-2017(2022) Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics
  • KS P ISO 10993-9:2007 Biological evaluation of medical devices － Part 9: Framework for identification and quantification of potential degradation products
  • 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 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 10993-9-2021 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
  • KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
  • KS P ISO 10993-20-2019 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
  • KS P ISO 10993-9:2018 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
  • KS P ISO 10993-9-2018 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
  • KS P ISO 10993-9:2021 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
  • KS P ISO 10993-20-2009(2024) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
  • KS P ISO 10993-15-2006(2016) Biological evaluation of medical devices － Part 15: Identification and quantification ofdegradation products from metals and alloys
  • KS P ISO 10993-15:2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
  • KS P ISO 10993-15:2006 Biological evaluation of medical devices － Part 15: Identification and quantification ofdegradation products from metals and alloys
  • KS P ISO 10993-15-2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
  • KS T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of 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

The Directorate General of Specifications and Metrology (DGSM)

  • OS GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
  • OS GSO ISO 10993-14:2016 Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics
  • OS GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
  • OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
  • OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO ISO 10993-13:2017 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
  • BH GSO ISO 10993-9:2017 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
  • BH GSO ISO/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
  • 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 23128:2023 Medical devices — Transfusion set and blood bag compatibility test method

Danish Standards Foundation

  • DANSK DS/EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • DANSK DS/EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • DANSK DS/ISO 10993-9:2021 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
  • DS/ISO 10993-9:2021 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
  • DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
  • DANSK DS/EN ISO 10993-9:2010 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
  • DANSK DS/ISO 10993-15:2023 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
  • DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
  • DANSK DS/EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
  • 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

International Organization for Standardization (ISO)

  • ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
  • ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • 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 10993-9:1999 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-9:2019 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
  • ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

American National Standards Institute （ANSI)

  • ANSI/AAMI/ISO 10993-13:2010(2014) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ANSI/AAMI/ISO 10993-13-2010(R2019) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices
  • ANSI/AAMI/ISO 10993-14:2001(2011) Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
  • ANSI/AAMI/ISO 10993-14:2001(R2019) Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
  • ANSI/AAMI/ISO 10993-9:2009(2014) Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
  • ANSI/AAMI/ISO 10993-15:2019 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
  • ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
  • ANSI/AAMI/ISO 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

Association for the Advancement of Medical Instrumentation

  • AAMI/ISO 10993-13:2010(R2019) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices
  • AAMI/ISO 10993-13:1999(R2004) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices
  • AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
  • AAMI/ISO 10993-14:2001(R2019) Biological evaluation of medical devices-Part 14: Identification and quantification of degradation products from ceramics
  • AAMI/ISO 10993-15:2019 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
  • AAMI/ISO 10993-9:2009(R2014) Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • AAMI/ISO 10993-15:2000(R2011) Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys
  • 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

GCC Standardization Organization

  • GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
  • GSO ISO 10993-14:2016 Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics
  • 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/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
  • GSO ISO 10993-15:2016 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
  • GSO ISO 10993-9:2016 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
  • 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

Canadian Standards Association (CSA)

European Committee for Standardization (CEN)

  • EN ISO 10993-13:1998 Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices ISO 10993-13:1998
  • EN ISO 10993-14:2001 Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics
  • EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
  • 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 14971:2007 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • EN ISO 10993-9:1999 Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
  • EN ISO 10993-9:2021 Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
  • EN ISO 10993-16:1997 Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables ISO 10993-16: 1997
  • EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices

Standards Norway

  • NS-EN ISO 10993-13:1998 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymers medical devices (ISO 10993-13:1998)
  • NS-EN ISO 10993-13:2009 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
  • NS-EN ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
  • SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
  • NS-EN ISO 10993-14:2009 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

Spanish Association for Standardization (UNE)

  • UNE-EN ISO 10993-13:2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:1998)
  • AENOR UNE-EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
  • UNE-EN ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
  • UNE-EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
  • UNE-EN ISO 10993-9:2022 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
  • 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 ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
  • UNE-EN ISO 10993-14:2002 Biological evaluation of medical devices. Part 14: Identification and quantification of degradation products from ceramics. (ISO 10993-14:2001)

Indonesia Standards

  • SNI ISO 10993-13:2015 Evaluasi biologis alat kesehatan - Bagian 13: Identifikasi dan kuantifikasi produk degradasi alat kesehatan polimer (ISO 10993-13:2010, IDT)

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

  • TCVN 7391-14-2007 Biological evaluation of medical devices.Part 14: Identification and quantification of degradation products from ceramics
  • TCVN 7391-15-2007 Biological evaluation of medical devices.Part 15: Identification and quantification of degradation products from metals and alloys

Bureau of Indian Standards

  • IS/ISO 10993-14-2001 Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics
  • IS/ISO 10993-9-2009 Biological Evaluation of Medical Devices Part 9 Framework for Identification and Quantification of Potential Degradation Products
  • IS/ISO 10993-15-2000 Biological Evaluation of Medical Devices Part 15 Identification and Quantification of Degradation Products from Metals and Alloys
  • IS/ISO/TS 10993-20-2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
  • IS 12572-9-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 9 Method of Test for Skin Irritation by Solid Medical Devices
  • IS 18855-2024 Medical Devices - Transfusion Set and Blood Bag Compatibility - Test Method

Swedish Institute for Standards

  • SS-EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
  • SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)

National Electrical Manufacturers Association（NEMA)

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

South African Bureau of Standard

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

Bureau of Philippine Standards

  • PNS ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

International Electrotechnical Commission (IEC)

  • IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Comitato Elettrotecnico Italiano

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

Standard Association of Australia （SAA）

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

European Committee for Electrotechnical Standardization（CENELEC）

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

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