Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
Covers low temperature steam and formaldehyde sterilization of medical devices.
The text of this standard is sold by ISO and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| European Union | Harmonized | EN ISO 25424:2019 with amendment A1:2022 (ISO 25424:2018) | - | Recognition number MDR entry 5; IVDR entry 4. Effective July 19, 2021. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
| United Kingdom | Recognized | EN ISO 25424:2019 with amendment A1:2022 | - |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: ISO 11135, GB 18279-2023, ISO 11137-1, ISO 11137-2, ISO 17665, ISO 11737-1, ISO 11737-2, ISO 10993-7, ISO 14160, ISO 13408-1. See .
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| Recognition number List row 200. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
| Australia | Recognized | ISO 25424:2018 | - | Compliance with the standard is treated as applying the matching parts of the conformity assessment procedures. It is an optional route. It applies to devices supplied sterile. |