GB 18279-2000
AbolishedMedical devices--Validation androutine control of ethylene oxide sterilization
医疗器械 环氧乙烷灭菌 确认和常规控制
Application Summary AI generated
This standard specifies the requirements for the validation and routine control of ethylene oxide sterilization processes for medical devices. It is applied by medical device manufacturers and sterilization service providers to ensure that sterilized products meet specified sterility assurance levels. The standard covers process definition, equipment qualification, microbiological performance qualification, and ongoing monitoring during production.
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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.