MDR & IVDR: New harmonised standards

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):

Reference of the standard

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

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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