Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
IDT ISO 11135-1:2007
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
GB 18279的本部分规定了医疗器械环氧乙烷灭菌过程的开发、确认和常规控制的要求。
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