UPDATED AS OF APRIL 2025
You can always check the latest status, find and download the harmonised standard under the IVDR / IVDMDR at the following link: https://genorma.com/en/directive/show/2017/746
Obtain and download harmonised standards that are cited in the Official Journal under the In Vitro Diagnostic Medical Devices, as listed in the following implementing acts:
Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council:
DISCLAIMER: This is an informative page, providing added value information on standards. Information may evolve and change subject to the publication of other legislative texts. Genorma.com informs its users that users are responsible for deciding the version of the standard that is applicable to their products, and not Genorma.com. As a consequence, Genorma.com users are encouraged to check the latest versions of the legal text accessible through the EUR-LEX website
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)
60.60 Standard published
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
60.60 Standard published
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
99.60 Withdrawal effective
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
99.60 Withdrawal effective
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
60.60 Standard published
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
60.60 Standard published
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
60.60 Standard published
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
60.60 Standard published
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
60.60 Standard published
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
60.60 Standard published
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
60.60 Standard published
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
60.60 Standard published
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
60.60 Standard published
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
60.60 Standard published
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
60.60 Standard published
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
60.60 Standard published
