On 5 July 2023, the Official Journal of the European Union published two new harmonised standards for sterilisation under the Medical Devices Regulation (MDR ) and In Vitro Medical Devices Regulation (IVDR):
- Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices
- Commission Implementing Decision (EU) 2023/1411 of 4 July 2023 amending Implementing Decision (EU) 2021/1195 as regards a harmonised standard for sterilization of health care products
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Reference of the standard |
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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 |
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EN ISO 10993-10:2023 Biological evaluation of medical devices — Part 10: Tests for skin sensitization |
Source: OJEU
All implementing acts concerning harmonised standards are available in our MDlaw Library – STANDARDS.
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