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.
作者
郑建功
ZHENG Jian-gong(Shanghai Medical Device and Cosmetics Evaluation and Verification Center,Shanghai 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
关键词
医疗器械
环氧乙烷灭菌
过程挑战装置
不合格案例
medical devices
ethylene oxiede sterilization
process challenge device
unqualified cases
