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ISO/TS 19930:2017现行

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

出版:International Organization for Standardization

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基本信息
标准编号: ISO/TS 19930:2017
发布时间:2017/11/23 0:00:00
标准类别:TechnicalSpecification
出版单位:International Organization for Standardization
标准页数:23
标准简介

This document provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10?6.