
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
出版:Standardiserings-Kommissionen I Sverige

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基本信息
标准编号: SS-EN ISO 11137-2:2015
标准类别:Standard
出版单位:Standardiserings-Kommissionen I Sverige
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.