New standards for biocompatibility, sterilization and processing have been harmonised

Recently CEN and Cenelec revised the harmonised standards and added sterilization, biocompatibility, and processing standards to the list. The standards and the amendments satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/745. Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in the MDR.

Standard Number	Standard Name
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
EN ISO 10993-17:2023	Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
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
EN ISO 11137-2:2015 EN ISO 11137-2:2015/A1:2023	Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
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.
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.
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

New harmonized standards: https://eur-lex.europa.eu/eli/dec_impl/2024/815/oj

Summary list of titles and references of harmonised standards: https://ec.europa.eu/docsroom/documents/58477