GB/T 16886.7-2015
ActiveBiological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
医疗器械生物学评价 第7部分：环氧乙烷灭菌残留量
Application Summary AI generated
This standard specifies the allowable limits, detection methods, and sampling procedures for ethylene oxide (EO) and its byproduct residues (e.g., ethylene chlorohydrin) on medical devices sterilized with EO gas. It is applied by manufacturers and testing laboratories to ensure that sterilized single-use medical products, such as surgical kits, catheters, and implants, meet biological safety requirements before clinical use. The standard is critical for quality control in healthcare settings to prevent patient exposure to toxic residuals.
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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.