ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019现行
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
出版：Association for the Advancement of Medical Instrumentation
专家解读视频
基本信息
标准编号： ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019
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
Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products.
本标准替代的旧标准
AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000
等同采用的国际标准
ISO 11137-1:2006/Amd 2:2018 - Identical
