ISO 13004:2022 医疗保健产品灭菌 辐照 所选灭菌剂量的证实：VDmaxSD法

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

本文件描述了一种证实所选灭菌剂量为17,5？kGy，20？kGy，22，5？kGy，27.5？kGy，30？kGy，32.5？kGy还是35？达到无菌保证水平（SAL）10的kGy？6或更少用于保健产品的辐射灭菌。本文件还规定了用于证明经证实的灭菌剂量持续有效性的灭菌剂量审核方法。注1？灭菌剂量的选择和确认用于满足ISO？11137？1.本文件不适用于所选灭菌剂量17,5？kGy，20？kGy，22，5？kGy，27.5？kGy，30？kGy，32.5？kGy还是35？克GY。如果整个产品项目的平均生物负载超过所选灭菌剂量规定的限度，则该方法不用于确认所选灭菌剂量（见表？3）。注2？证实25的选定灭菌剂量的方法？kGy和15？kGy不包括在本文件中。它们在ISO中有描述？11137？2.如果决定使用该灭菌剂量确定方法，则应根据此处规定的要求（应）和指南（应）遵循该方法。

This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 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.This document does not apply to other sterilization doses than the substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).NOTE 2   The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this document. They are described in ISO 11137？2.If the decision is made to use this method of sterilization dose establishment, the method is intended to be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.

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