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UNI EN ISO 11137-2:2008被替代

Sterilization Of Health Care Products - Radiation - Part 2: Establishing The Sterilization Dose

出版:Italian Standards

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基本信息
标准编号: UNI EN ISO 11137-2:2008
标准类别:Standard
出版单位:Italian Standards
标准页数:0
标准简介

Describes methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10[-6]. Also ascertains methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.

标准备注

Supersedes UNI EN 552. (07/2006)

本标准替代的旧标准

UNI EN ISO 11137-2:2006

UNI EN 552:2002

替代本标准的新标准

UNI EN ISO 11137-2:2012