
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD]
出版:Association for the Advancement of Medical Instrumentation

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基本信息
标准编号: AAMI ISO TIR 13004 : 2013
标准类别:Standard
出版单位:Association for the Advancement of Medical Instrumentation
标准页数:0
标准简介
Specifies a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.
本标准替代的旧标准
等同采用的国际标准
ISO TS 13004 : 2013(R2017) - Identical