GB 18280-2000
AbolishedSterilization of healthcare products--Requirement for validation and routine control--Radiation sterilization
医疗保健产品灭菌 确认和常规控制要求 辐射灭菌
Application Summary AI generated
This standard specifies the requirements for the validation, process control, and routine monitoring of radiation sterilization for healthcare products. It is applied in the medical device and pharmaceutical industries to ensure that products such as surgical instruments, implants, and single-use medical supplies are effectively sterilized using gamma, electron beam, or X-ray radiation. The standard is used by manufacturers and testing laboratories to establish, document, and maintain sterilization processes that achieve a specified sterility assurance level (SAL).
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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.