GB 18281.4-2015
AbolishedSterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
医疗保健产品灭菌 生物指示物 第4部分：干热灭菌用生物指示物
Application Summary AI generated
This standard specifies the requirements for biological indicators used to validate and monitor dry heat sterilization processes for healthcare products. It is applied in hospitals, pharmaceutical manufacturing, and medical device sterilization facilities to ensure that dry heat cycles (e.g., ovens, tunnels) effectively inactivate resistant microorganisms like Geobacillus stearothermophilus. The standard defines performance testing, labeling, and shelf-life criteria for these indicators to confirm sterility assurance in contexts such as sterilizing glassware, metal instruments, or anhydrous materials.
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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.