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EU IVD Regulation

(EU) 2017/746 — 23 entries. Source: 02021D1195-20260617. Snapshot: 2026-08-16.

AnnexReferenceTitleWithdrawal
ANNEXEN ISO 11135:2014Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process f
ANNEXEN ISO 11137-1:2015Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process fo
ANNEXEN ISO 11737-2:2020Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance o
ANNEXEN ISO 25424:2019Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a ste
ANNEXEN ISO 11737-1:2018Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:201
ANNEXEN ISO 13408-6:2021Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
ANNEXEN ISO 13485:2016Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
ANNEXEN ISO 15223-1:2021Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)
ANNEXEN ISO 17511:2021In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control mate
ANNEXEN ISO 14971:2019Medical devices – Application of risk management to medical devices (ISO 14971:2019)
ANNEXEN ISO 11137-2:2015Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
ANNEXEN ISO 11607-1:2020Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2
ANNEXEN ISO 11607-2:2020Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
ANNEXEN ISO 13408-1:2024Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)
ANNEXEN ISO 20916:2024In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)
ANNEXEN 556-1:2024Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 1: Requirements for terminally sterilized medica
ANNEXEN 556-2:2024Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 2: Requirements for aseptically processed medica
ANNEXEN ISO 17665:2024Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for m
ANNEXEN ISO 18113-1:2024In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO
ANNEXEN ISO 18113-2:2024In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
ANNEXEN ISO 18113-3:2024In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional
ANNEXEN ISO 18113-4:2024In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (IS
ANNEXEN ISO 18113-5:2024In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing