基于无菌医疗器械安全性的环氧乙烷解析探讨  

Analysis of Ethylene Oxide Based on the Safety of Sterile Medical Devices

作　　者：杨盛林[1] 郑雯雯 张文翠[1] 马功 YANG Sheng-lin;ZHENG Wen-wen;ZHANG Wen-cui;MA Gong(Shandong Center for Food and Drug Evaluation&Cerrification,Shandong Jinan 250014)

机构地区：[1]山东省食品药品监督管理局审评认证中心,山东济南250014

出　　处：《中国医疗器械信息》2021年第5期6-7,21,共3页China Medical Device Information

摘　　要：环氧乙烷灭菌是无菌医疗器械常用的灭菌方式,其具有室温下易挥发的特性,检测也具有不可再现的特性。环氧乙烷可以杀灭微生物,对人体本身也有毒害作用。文章介绍环氧乙烷灭菌的原理及检测相关标准,并对影响环氧乙烷解析的参数进行梳理和归纳,为医疗器械生产企业和监管人员提供参考。Ethylene oxide sterilization is a common sterilization method for sterile medical devices,but it is volatile at room temperature,and its detection is also non reproducible.Ethylene oxide can kill microorganisms also toxic to human body.This paper introduces the principle,hazards and testing standards of ethylene oxide sterilization,summarizes the parameters affecting the diffusion analysis of ethylene oxide simultaneously,so as to provide reference for medical device manufacturers and regulators.

关 键 词：无菌医疗器械 环氧乙烷 解析验证 

分 类 号：R187.2[医药卫生—流行病学]