
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:Danish Standards

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基本信息
标准编号: DS ISO/TS 19930 : 2017
标准类别:Standard
出版单位:Danish Standards
标准页数:0
标准简介
Gives 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.