标准编号：ISO 13004:2022
中文名称：医疗保健产品灭菌 辐照 所选灭菌剂量的证实：VDmaxSD法
英文名称：Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
发布日期：2022-10
标准范围
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, −6 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1.
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