Chinese Standard: GB/T 31995-2015

Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose method VDmax

全国核能标准化技术委员会(SAC/TC 58)

本标准规定了辐射灭菌使医疗保健产品达到10-6无菌保证水平的选定的灭菌剂量的证实和剂量审核方法。
本标准适用于整个产品单元的平均生物负载符合选定剂量所要求的平均生物负载范围的医疗保健产品。

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