Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives
Covers liquid chemical sterilization of single-use devices made with animal tissues and their derivatives.
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 14160:2021 (ISO 14160:2020) | - | Recognition number MDR entry 11. Effective January 5, 2022. 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 14160:2021 | - | Recognition number List row 144a. 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. |
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 25424, 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.
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |
| Australia | Recognized | ISO 14160:2011 | - | 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. |