Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
IDT ISO 17665-1:2006
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
GB 18278的本部分规定了医疗器械湿热灭菌的开发、确认和常规控制的要求。
注： 虽然本部分的范围限于医疗器械，但它规定的要求和提供的指南可适用于其他健康相关产品。〖HT〗
本部分包含以下湿热灭菌过程，但不限于此：
a) 饱和蒸汽重力排气系统；
b) 饱和蒸汽动力排气系统；
c) 空气蒸汽混合气体；
d) 水喷淋；
e) 水浸没。
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