医疗器械部件安全关键度研究

Study on Safety Critical Degree of Components of Medical Device

通过分析事故发生机理,将影响医疗器械部件安全关键度的因素合理的分为几个指标。利用部件失效的时间特性、部件间的相关性对各指标进行了调整;并运用分析工具,如FTA、FMEA等对其进行了分析、量化;最后对医疗器械部件的安全关键度进行了综合求取。

By analyzing the principles of the accident, separate the factors that affect the safety - critical degree of components of medical device into some index reasonably. And the index was adjusted by the time characteristics of component failure and the correla- tion between components. Moreover analyzed and quantified it by analytical tools, such as FTA, FMEA, etc. Finally, the degree of safety - critical of medical device components was integrated count.