GB/T 19633.1-2015
AbolishedPackaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求
Application Summary AI generated
This standard specifies requirements for materials, sterile barrier systems, and packaging systems used to maintain sterility of terminally sterilized medical devices. It is applied by medical device manufacturers and healthcare facilities in China to ensure packaging integrity from production through storage and transport until point of use. The standard covers packaging for devices sterilized by methods such as ethylene oxide, radiation, or steam, providing a framework for validation and quality control.
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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.