Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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 | Fifth edition 2021 with Amendment 1 (2025) | - | Recognition number 2-314. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| European Union | Harmonized | EN ISO 10993-12:2021 with amendment A1:2025 (ISO 10993-12:2021) | - | Recognition number MDR entry 7a. Effective January 5, 2022. Transition until December 15, 2027. The earlier reference without the 2025 amendment is deleted from this date.. 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 10993-1, GB/T 16886.1-2022, GB/T 16886.4-2022, GB/T 16886.5-2017, GB/T 16886.7-2015, GB/T 16886.10-2017, GB/T 16886.11-2021, GB/T 16886.12-2017, GB/T 16886.18-2022, ISO 10993-9, ISO 10993-15. 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 10993-12:2021+A1:2025 | - | Recognition number List row 78. 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 | Referenced | - | - | Named in the notice on biological safety evaluation as a standard related to the sample preparation test or evaluation, without a stated edition (the latest standard applies when new tests are run). |
| China | National equivalent | - | GB/T 16886.12-2017Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | Recommended national standard that a regulator names, together with the ISO 10993 series, as technical requirements for biological test data. |
| 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. |