Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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 |
|---|---|---|---|---|
| United States | Recognized | Third edition 2013 with Amendment 1 (2022) | - | Recognition number 14-580. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| European Union | Harmonized | EN ISO 11137-2:2015 with amendment A1:2023 (ISO 11137-2:2013) | - | Recognition number MDR entry 22; IVDR entry 11. Effective March 8, 2024. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
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 17665, ISO 11737-1, ISO 11737-2, ISO 10993-7, ISO 25424, 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.
| United Kingdom | Recognized | EN ISO 11137-2:2015 with amendment A1:2023 | - | Recognition number List row 88. 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. |
| Japan | Adopted with changes | ISO 11137-2:2013, modified JIS version (the sample entry also cites ISO/TS 13004:2013) | JIS T 0806-2:2014ヘルスケア製品の滅菌―放射線―第２部：滅菌線量の確立 | Named as the way to decide the sterilization dose in the sample application entry for radiation sterilization. |
| 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 11137-2:2013 | - | 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. |