医疗器械产品常用灭菌方法
2013-03-13 09:39:52 益择发布焦彦超
(北京市药品监督管理局密云分局，北京 101500)
灭菌是无菌医疗器械生产的关键环节，其涉及的参数、环境相互关联，是一种需要严格控制的特殊过程。常见灭菌的方
法基本上为以下几种：干热灭菌法、湿热灭菌法、辐射灭菌法、紫外线灭菌法、环氧乙烷灭菌法、臭氧灭菌法。不同的灭菌方法
对应于不同的预期用途和产品类型，从原理、应用、预期用途对各种灭菌方法进行分析、归纳、比对。
医疗器械； 灭菌；方法
中图分类号： R197.39 文献标识码： A 文章编号： 1008-455X(2009) 04-0024-04
Common Methods for Sterilization of Medical Devices
Jiao Yanchao
(Miyun Branch, Beijing Drug Supervision and Administration Bureau Beijing, 101500)
Abstract: Sterilization process is the key step in the production of sterilized medical devices. In this process, involved parameters are
correlated with the environment, thus, it is a process required to be stringently controlled. The commonly used methods of sterilization are:
dry-heat sterilization, moist-dry sterilization, radiation sterilization, UV sterilization, ethylene oxide sterilization and ozone sterilization.
In this article, with respect to different usages and products, the analysis, comparison and induction for these sterilization methods, from
the aspects of principle and application, were carried out.
Keywords: medical device; sterilization; method
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