保健产品的灭菌.辐射.选定灭菌剂量的验证:方法VDmaxSD

[中文适用范围]： 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 或 35 kGy 的方法，该剂量可达到无菌保证水平 (SAL)保健品辐射灭菌≤10−6。 本文件还规定了灭菌剂量审核方法，用于证明经证实的灭菌剂量的持续有效性。 注 1：灭菌剂量的选择和证实用于满足 ISO 11137-1 过程定义中建立灭菌剂量的要求。 本文件不适用于除证实所选灭菌剂量 17.5 kGy、20 kGy、22.5 kGy、27.5 kGy、30 kGy、32.5 kGy 或 35 kGy 之外的其他灭菌剂量。 如果整个产品的平均生物负载超过所选灭菌剂量规定的限值（见表 3），则该方法不用于证实所选灭菌剂量。 注 2：本文件中不包括选定的 25 kGy 和 15 kGy 灭菌剂量的验证方法。 ISO 11137-2 中对它们进行了描述。 如果决定使用这种灭菌剂量确定方法，则应按照本文规定的要求（应）和指南（应）遵循该方法。 [外文原描述]： 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.