Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (JIS version)
permitted limits and measurement methods for ethylene oxide and ethylene chlorohydrin residues on devices, and how to judge conformity for release. Identical adoption of the international standard.
The text of this standard is sold by Japanese Industrial Standards Committee 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
No market listing is published yet.
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 14160. 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.