GB 18281.2-2015
AbolishedSterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
医疗保健产品灭菌 生物指示物 第2部分：环氧乙烷灭菌用生物指示物
Application Summary AI generated
This standard specifies requirements for biological indicators used to validate and monitor ethylene oxide sterilization processes for healthcare products. It is applied in medical device manufacturing and healthcare facilities to ensure sterilization efficacy by using resistant bacterial spores (typically Bacillus atrophaeus) as biological test systems. The standard governs the performance, testing, and labeling of these indicators for ethylene oxide sterilization cycles.
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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.