Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Requirements for developing, validating and routinely controlling an ethylene oxide sterilization process for medical devices. It takes the place of the earlier GB 18279.1-2015.
In force from 2026-10-01. It fully replaces GB 18279.1-2015, which was abolished on the same date.
The text of this standard is sold by China national standard 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, ISO 11137-1, ISO 11137-2, ISO 17665, ISO 11737-1, ISO 11737-2, ISO 10993-7, ISO 25424, ISO 14160, ISO 13408-1. See .
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