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

专家解读视频
基本信息
标准编号: DS EN ISO 11137-2:2013
发布时间:2013/7/5 0:00:00
标准类别:Standard
出版单位:Danish Standards
标准页数:88
标准简介
Defines 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
2012 Edition is still active and will be withdrawn on 31-12-2013. (07/2013)
替代本标准的新标准
等同采用的国际标准
EN ISO 11137-2:2015 - Identical