The European Commission has recognized 9 harmonized standards from the International Organization for Standardization (ISO) and the International Electrical Commission (IEC) related to medical devices. These ISO and IEC documents are used unchanged like European standards EN ISO or EN IEC.
Manufacturers of the products who have already made products compliant with the relevant ISO/IEC standards and intend to supply them to the European Union can use certificates of conformity to meet the requirements of the European Medical Devices Regulation (MDR).
The approved standards cover a number of important topics including biological evaluation of medical devices, sterilization, aseptic processing, quality management systems and more.
The endorsement of 9 harmonized standards came shortly after the approval of 5 thematic standards recognized by the European Commission in July 2021. The total number of standards harmonized under the Medical Devices Regulation has thus reached 14. The full list is as follows:
Documents approved by Commission Implementing Regulation (EU) 2021/1182 of July 16, 2021:
- 1. EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation”
- 2. EN ISO 11135:2014 "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)
- 3. EN ISO 11137-1:2015 “Sterilization of health care 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)< /li>
- 4. 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)
- 5. 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)
Documents approved by Commission Implementing Regulation (EU) 2022/6 of January 4, 2022:
- 6. EN ISO 10993-9:2021 “Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products” (ISO 10993-9:2019)
- 7. EN ISO 10993-12:2021 “Biological evaluation of medical devices - Part 12: Sample preparation and reference materials” (ISO 10993-12:2021)
- 8. EN ISO 11737-1:2018 “Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products” (ISO 11737-1:2018)
- 9. EN ISO 13408-6:2021 “Aseptic processing of health care products - Part 6: Isolator systems” (ISO 13408-6:2021)
- 10. EN ISO 13485:2016 “Medical devices — Quality management systems — Requirements for regulatory purposes” (ISO 13485:2016)
- 11. EN ISO 14160:2021 “Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices” ( ISO 14160:2020)
- 12. EN ISO 15223-1:2021 “Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements” (ISO 15223-1:2021)
- 13. EN ISO 17664-1:2021 “Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices” (ISO 17664-1:2021)
- 14. EN IEC 60601-2-83:2020 “Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment”
According to the official notice from the European Commission, devices complying with the relevant agreed standards or parts of these standards published in the Official Journal of the European Union should be considered to be compliant with the requirements of the Medical Devices Regulation to which these standards apply or parts thereof to be viewed as.
