Overview
EN ISO 11137-2:2015/A1:2023 (ISO 11137-2:2013/Amd 1:2022) is a European amendment to the international standard on radiation sterilization of health care products. It specifically addresses the process of establishing the sterilization dose for devices sterilized by ionising radiation. Prepared by ISO/TC 198 in collaboration with CEN/TC 204, the amendment updates clause content and normative references to support development, validation and routine control of radiation sterilization processes.
Note: the provided scope record indicates a publication hold (“lack of compliance” - 2022-06-21). Users should verify current national adoption status and Official Journal citations before relying on regulatory claims.
Key topics and requirements
- Purpose: Requirements for establishing a validated sterilization dose for medical devices and in vitro diagnostic devices sterilized by ionising radiation.
- Process coverage: Development, validation and routine control of sterilization dose determination (used together with EN ISO 11137-1).
- Regulatory alignment: Informative Annex ZA/ZB map the amendment to the General Safety and Performance Requirements of EU Regulation 2017/745 (MDR) and 2017/746 (IVDR); compliance with normative clauses can confer a presumption of conformity when the standard is cited in the Official Journal.
- Limitations:
- Does not cover packaging design or evidence that packaging integrity is maintained to point of use.
- Does not address manufacturing aspects unrelated to attainment of sterility.
- Normative references: Cross-references to other sterilization and microbiological standards (e.g., EN ISO 11137‑1, EN ISO 11737‑1/2, ISO 13004/VDmaxSD).
Applications
Who uses this amendment and how:
- Medical device and IVD manufacturers - to set and justify sterilization doses during product development, validation and routine production control.
- Sterilization service providers - to align dose-setting practices and documentation with accepted international and European methods.
- Quality, regulatory and RA teams - to support conformity assessments under MDR/IVDR when the standard is harmonized/cited.
- Test laboratories and auditors - to evaluate sterilization dose substantiation and routine control records.
Practical outcomes include a documented, validated sterilization dose strategy that supports product sterility claims and regulatory submissions (subject to current adoption/citation).
Related standards
Always confirm the latest published edition, national adoption status and whether the amendment is cited in the Official Journal of the European Union before applying the standard for regulatory conformity.
