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XP ISO/TS 19930 : 2017 XP現行

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:Association Francaise de Normalisation

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基本信息
標準編號: XP ISO/TS 19930 : 2017 XP
標準類別:Miscellaneous Product
出版單位:Association Francaise de Normalisation
標準頁數:0
標準簡介

Describes 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.

等同采用的國際標準

ISO/TS 19930:2017 - Identical

ISO/TS 19930:2017 - Identical