ISO 10993-5
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISOInternational standardBiocompatibilityMedical devicesHigh confidenceLast verified October 4, 2026
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.
Recognition by market
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|
| United States | Recognized | - | - | Voluntary: a declaration of conformity to a recognized standard can be used in a submission.. The recognition number and edition were not confirmed because the recognition database was not reachable. The ASCA program lists this standard among FDA-recognized consensus standards for biocompatibility testing. |
| European Union | Harmonized | EN ISO 10993-5:2009 with amendment A11:2025 |
Testing requirements that cite it
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.
