GB/T 18279.2-2015
ActiveSterilization of health care products—Ethylene oxide—Part 2: Guidance on the application of GB 18279.1
医疗保健产品的灭菌 环氧乙烷 第2部分：GB 18279.1应用指南
Application Summary AI generated
This standard provides guidance on applying GB 18279.1 for validating and controlling ethylene oxide (EO) sterilization processes for medical devices. It is used by healthcare product manufacturers and sterilization facilities to ensure consistent sterility assurance, covering process definition, equipment qualification, and routine monitoring. The standard applies specifically to EO sterilization in the medical device industry, including hospitals and industrial sterilization sites.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.