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首页> 外文期刊>ISO Bulletin >ISO/TS 15843, Sterilization of health care products Radiation sterilization-- Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
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ISO/TS 15843, Sterilization of health care products Radiation sterilization-- Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits

机译：ISO / TS 15843，保健产品的灭菌辐射灭菌-验证剂量实验和灭菌剂量审核以及灭菌剂量审核频率的产品系列和抽样计划

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摘要

ISO/TS 15843 describes approaches to the selection and auditing of a sterilization dose that economize in relation to the number of product units required while maintaining assurance of attaining the desired sterility assurance level (SAL). These approaches address-establishing and maintaining product families for the selection and auditing of a sterilization dose,-sampling plans for verification dose experiments and sterilization dose audits, and-frequency of sterilization dose audits.This Technical Specification is intended to be used in conjunction with ISO 11137:1995, Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization. One of the activates encompassed within ISO 11137 is the selection and routine auditing of the sterilization dose to be applied to health care products.
机译：ISO / TS 15843描述了选择和审核灭菌剂量的方法，这些方法可在保持达到所需无菌保证水平（SAL）的保证的同时，节省所需产品的数量。这些方法旨在建立和维护用于选择和审核灭菌剂量的产品系列，用于验证剂量实验和灭菌剂量审核的采样计划以及灭菌剂量审核的频率。本技术规范旨在与ISO 11137：1995，医疗保健产品的灭菌-验证和常规控制的要求-辐射灭菌。 ISO 11137包含的一项激活措施是对应用于医疗保健产品的灭菌剂量的选择和常规审核。

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