The European Commission officially recognized nine harmonised standards for medical devices in commission implementing decision (EU) 2022/6 on January 4, 2022, which device manufacturers can use to meet the Medical Devices Regulation (MDR) conformity requirements.
The nine new harmonised standards join a previous set of five standards recognized by the commission in July 2021, making a total of 14 harmonised standards. The Commission requested the European Committee for Standardization (CEN) and the European Committee for Electro technical Standardization (Cenelec) to revise the standards that were recognized.
The standards cover a variety of topics, such as biological evaluation of medical devices, sterilization, aseptic processing, quality management systems, and the use of symbols in product information.
“Devices that are in compliance with the applicable harmonised standards, or relevant parts of those standards, the references of which have already been published in the Official Journal of the European Union, are to be deemed to be in accordance with the guidelines of that Regulation covered by those standards or parts thereof,” according to the Commission.
| No | Referenced Revision | Title of Harmonised Standard |
| As per Commission Implementing Decision (EU) 2021/1182, dated July 16, 2021 | ||
| 1 | EN ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) |
| 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) |
| 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) |
| As per Commission Implementing Decision (EU) 2022/6:The following entries have been added in the Annex of Implementing Decision (EU) 2021/1182, dated January 04, 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) EN ISO 11737-1:2018/A1:2021 |
| 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) EN ISO 13485:2016/A11:2021 |
| 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 EN IEC 60601-2-83:2020/A11:2021 |
