Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for 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 |
|---|---|---|---|---|
| United States | Recognized | First edition 2024-03 | - | Recognition number 14-601. Voluntary: a declaration of conformity to a recognized standard can be used in a submission.. ISO 17665-1 First edition 2006-08 and ISO TS 17665-2 First edition 2009-01 were withdrawn with a transition that refers to the new entry. |
| European Union | Harmonized | EN ISO 17665:2024 (ISO 17665:2024) | - |
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 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.
| Recognition number MDR entry 41; IVDR entry 18. Effective January 30, 2026. 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 17665-1:2006 | - | Recognition number List row 179. 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.. The designated reference is part 1 of the moist heat sterilization standard, in its 2006 edition. |
| Japan | Adopted | ISO 17665-1:2006, identical JIS version | JIS T 0816-1:2010ヘルスケア製品の滅菌―湿熱―第１部：医療機器の滅菌プロセスの開発，バリデーション及び日常管理の要求事項 | Named as the validation standard in the sample application entry for moist heat sterilization. The notice also accepts equal or higher foreign standards. |
| 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 17665-1:2006 | - | 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.. The order names the 2006 edition of part 1. |