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医疗器械干热灭菌过程的开发、确认和常规控制要求 Requirements for the development,validation and routine control of dry heat sterilization process for medical devices
发布日期: 2016-03-23
实施日期: 2017-01-01
本标准适用于采取干热方式对医疗器械进行灭菌和去热原的过程。本标准规定了医疗器械在干热灭菌过程中的开发、确认和常规控制要求。本标准不适用于红外线或微波灭菌
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