The Commission of the European Union (EU) has updated its list of harmonized standards applicable to in-vitro medical devices to reflect the latest available technical and scientific information.
According to Commission Implementing Decision (EU) 2021/1195, two new standards can now be used to demonstrate compliance with applicable requirements of the EU’s In Vitro Diagnostic Device Regulation, (EU) 2017/745. These are:
- EN ISO 11737-2:2020, “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)”
- EN ISO 25424:2019, “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)”
In addition, the Commission’s Implementing Decision designated amendments to current harmonized standards, as follows:
- EN ISO 11135:2014/A1:2019, amendment to “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)”
- EN ISO 11137-1:2015/A2:2019, amendment to “Sterilization of healthcare 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)”
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.
