MDR: Eight standards have been newly harmonized. These fall under Commission Implementing Decision (EU) 2024/815. The link is available: HERE
IVDR: Three standards have been newly harmonized. These fall under Commission Implementing Decision (EU) 2024/817. The link is available: HERE
Reference number of the standard | Title of the standard |
---|---|
EN 455-3:2023 | Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |
EN ISO 10993-15:2023 | Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) |
EN ISO 10993-17:2023 | Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) |
EN ISO 10993-18:2020 EN ISO 10993-18:2020/A1:2023 | Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) |
EN ISO 11137-2:2015 EN ISO 11137-2:2015/A1:2023 | Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
EN ISO 11607-1:2020 EN ISO 11607-1:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) |
EN ISO 11607-2:2020 EN ISO 11607-2:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) |
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) |
Reference number of the standard | Title of the standard |
---|---|
EN ISO 11137-2:2015 EN ISO 11137-2:2015/A1:2023 | Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
EN ISO 11607-1:2020 EN ISO 11607-1:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) |
EN ISO 11607-2:2020 EN ISO 11607-2:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) |
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