标准编号：ISO/TS 19930:2017
中文名称：最大承受处理达到最大10−6无菌、保证水平面的晚期的基于风险的方法来保证无菌消毒、一次性医疗产品指导
英文名称：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 assu
发布日期：2017-12
标准范围
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 −6 product that is unable to withstand processing to achieve maximally a SAL of 10 . In addition, this document provides a) background information on the assurance of sterility and sterility assurance level, and −6 b) guidance on strategies that can allow the achievement of a maximal SAL of 10 . This document describes the elements of a quality management system which are applied to enable the appropriate selection of a SAL for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10−6 .
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