AAMI ISO 11137-2:2013现行
Sterilization Of Health Care Products - Radiation - Part 2: Establishing The Sterilization Dose
出版：Association for Advancement of Medical Instrumentation
专家解读视频
基本信息
标准编号： AAMI ISO 11137-2:2013
发布时间：2013/7/2 0:00:00
标准类别：Standard
出版单位：Association for Advancement of Medical Instrumentation
标准页数：88
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].
标准备注
Supersedes AAMI ISO 11137, AAMI TIR27 and AAMI ISO TIR 13409 (03/2006)
替代本标准的新标准
等同采用的国际标准
ISO 11137-2 : 2013(R2018) - Identical
