GB 18280.1-2025
UpcomingSterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices
医疗产品灭菌 辐射 第1部分：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 requirements for the development, validation, and routine monitoring of radiation sterilization processes for medical devices. It is applied by manufacturers and sterilization facilities to ensure that products such as surgical instruments, implants, and single-use medical supplies achieve a specified sterility assurance level (SAL) using gamma, electron beam, or X-ray radiation. The standard provides a framework for process qualification, dose setting, and ongoing control to meet regulatory and safety requirements in healthcare product sterilization.
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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.