GB 18279-2023
UpcomingSterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
医疗保健产品灭菌 环氧乙烷 医疗器械灭菌过程的开发、确认和常规控制要求
Application Summary AI generated
This standard specifies the requirements for the development, validation, and routine monitoring of ethylene oxide sterilization processes for medical devices. It is applied by medical device manufacturers and sterilization service providers to ensure that products such as surgical instruments, implants, and single-use supplies are effectively sterilized while maintaining safety and quality. The standard is used in healthcare product manufacturing and regulatory compliance contexts, particularly for devices that cannot withstand high-temperature sterilization methods.
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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.