AAMI TIR56:2013/(R)2020-医疗器械灭菌用柔性袋系统环氧乙烷灭菌过程的开发、验证和常规控制指南-国家数字标准馆

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Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices 医疗器械灭菌用柔性袋系统环氧乙烷灭菌过程的开发、验证和常规控制指南

发布日期： 2013-12-27

本AAMI技术信息报告（TIR）提供了EO灭菌过程的开发、验证和常规控制过程中需要考虑的信息，该过程使用单独密封的柔性灭菌袋内的气体扩散进行。

This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.

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发布单位或类别：美国-美国医疗器械促进协会

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