ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019現行
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
專家解讀視頻
基本信息
標準編號： ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019
標準類別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
標準頁數：0
標準簡介
Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products.
本標準替代的舊標準
AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000
等同采用的國際標準
ISO 11137-1:2006/Amd 2:2018 - Identical
