The Commission of the European Union (EU) has updated its list of harmonized standards applicable to medical devices to reflect the latest available technical and scientific information.
According to Commission Implementing Decision (EU) 2021/1182, five additional standards can now be used to demonstrate compliance with applicable requirements of the EU’s Medical Device Regulation, (EU) 2017/745. These are:
- EN ISO 10993-23:2021, the standard for “Biological evaluation of medical devices – Part 23: Tests for irritation”
- EN ISO 11135:2014 and EN ISO 11135:2014/A1:2019, the amended standard for “Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”
- EN ISO 11137-1:2015 and EN ISO 11137-1:2015/A2:2019, the amended standard for “Sterilization of healthcare products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”
- EN ISO 11737-2:2020, the standard for “Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process”
- EN ISO 25424:2019, the standard for “Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices.”
Under Commission rules, compliance with an EU harmonized standard confers a presumption of conformity with the corresponding essential requirements in EU harmonization legislation once the standard has been published in the Official Journal of the European Union.
