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ANSI/AAMI/ ISO 11137-2: 2013(R2019)现行

STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE

出版:Association for the Advancement of Medical Instrumentation

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基本信息
标准编号: ANSI/AAMI/ ISO 11137-2: 2013(R2019)
标准类别:Standard
出版单位:Association for the Advancement of Medical Instrumentation
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].

本标准替代的旧标准

AAMI ISO 11137-2 : 2013

等同采用的国际标准

ISO 11137-2 : 2013(R2018) - Identical