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ISO 11137-2 : 2013(R2018)现行

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

出版:International Organization for Standardization

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基本信息
标准编号: ISO 11137-2 : 2013(R2018)
标准类别:Revision
出版单位:International Organization for Standardization
标准页数:0
标准简介

This part of ISO 11137 specifies methods for 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].