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

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.