环氧乙烷灭菌过程挑战装置基本知识点及常见不合格案例  

Ethylene Oxide Sterilization Process Challenge Equipment Basic Knowledge Points and Common Unqualified Cases

作　　者：郑建功 ZHENG Jian-gong(Shanghai Medical Device and Cosmetics Evaluation and Verification Center,Shanghai 200020)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海200020

出　　处：《中国医疗器械信息》2023年第5期14-17,共4页China Medical Device Information

摘　　要：概述环氧乙烷灭菌过程挑战装置制备方面的基础知识,并结合现场核查案例对发现的问题进行梳理及简要分析,为监管人员和行业人士提供参考。This paper briefly summarizes the basic knowledge of ethylene oxide sterilization process challenge equipment preparation,and analyzes the problems found in the site verification to provide reference for regulators and industry personnel.

关 键 词：医疗器械 环氧乙烷灭菌 过程挑战装置 不合格案例 

分 类 号：R187.2[医药卫生—流行病学]