环氧乙烷灭菌在医疗器械行业的应用  

Ethylene Oxide Sterilization Applied in Medical Device Industry

作　　者：黄进 王向荣 

机构地区：[1]深圳市高科健医药科技有限公司 [2]业聚医疗器械(深圳)有限公司

出　　处：《中国医疗器械信息》2006年第10期41-44,共4页China Medical Device Information

摘　　要：本文介绍了环氧乙烷灭菌医疗器械相关的国际、国内标准,如何按照这些标准进行灭菌确认,及在灭菌确认中应注意的初始污染菌和短周期循环等事项。符合国际和国内相关规范的灭菌过程是无菌医疗器械进入国际市场的前提条件。This article introduces the intematinnal and national standards regarding ethylene oxide sterilization of medical device; sterflization validation princess according to these standards; and bioburden, short duration cycle, etc aspects during the sterilization validation. A sterilization process, which complies with international and national standards, is prerequisite to marketing sterile medical device globally.

关 键 词：环氧乙烷 灭菌确认 初始污染菌 短周期循环 

分 类 号：TH771.4[机械工程—仪器科学与技术]