摘要
环氧乙烷是一种广泛使用的化学灭菌剂,环氧乙烷灭菌是当前医疗器械灭菌最主要的两种方式之一。由于灭菌是一个特殊过程,其输出难以用常规的测量或检测手段加以验证,例如产品的无菌测试为破坏性测试,故有必要进行过程确认。本文主要讨论环氧乙烷灭菌过程确认中的某些概念和方法。
Ethylene Oxide is a widely used chemical sterilizing agent and ethylene oxide sterilization is one of the two major methods sterilizing medical devices. Since sterilization is a special process, the output of which cannot be verified on a regular and economic basis, for example, Test for Sterility of natural product is a destructive test, it＇s necessary to carry out sterilization process validation. This paper is focused on some concepts and methods regarding Ethylene Oxide sterilization validation.
出处
《中国医疗器械信息》
2013年第11期30-33,40,共5页
China Medical Device Information
关键词
环氧乙烷
灭菌
过程确认
Ethylene Oxide, sterilization, validation
