
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

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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.
等同采用的国际标准
ISO 11137-1:2006/Amd 2:2018 - Identical