
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

專家解讀視頻
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.
XP ISO/TS 19930 : 2017 XP - Identical
NEN NVN ISO/TS 19930 : 2017 - Identical
BS PD ISO/TS 19930 : 2017 - Identical
DS ISO/TS 19930 : 2017 - Identical
NEN NVN ISO/TS 19930 : 2017 - Identical
BS PD ISO/TS 19930 : 2017 - Identical
DS ISO/TS 19930 : 2017 - Identical
XP ISO/TS 19930 : 2017 XP - Identical