GB/T 18281.2-2024
ActiveSterilization 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 the requirements for biological indicators used to validate and monitor ethylene oxide sterilization processes for healthcare products. It is applied in medical device manufacturing, hospital sterilization services, and pharmaceutical industries to ensure that sterilization cycles effectively inactivate resistant bacterial spores. The standard provides testing methods for performance, including D-value determination and survival/kill kinetics, to confirm sterilization efficacy.
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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.