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《Beijing Biomedical Engineering》 2003-01
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Application of FTA:Risk Analysis of OAEs Detecting System

ZHOU Jingjie,CAO Yu,YE Datian.\ Department of Electrical Engineering,Tsinghua University,Beijing\ 100084  
In clinics,OAEs is a fast,objective,and non invasive method.Especially it can mean audio sensing performance of hearing peripheral system and cochlea of auris interna.Therefore,it is widely used for newborn hearing screening and testing functions of cochlea.The Chinese State Drug Administration has issued“Medical Apparatus Risk Management 1st Part Application of Risk Analysis”Standards,which have been started to implement.In the Standards,FTA(fault tree analysis),FMEA(feasible mode and effect analysis),and HAZOP(hazard and operability)are listed as material for Risk Analysis.In this paper fault tree analysis is used for risk analysis of OAEs detecting system.By means of analyzing the structure of system of OAEs detecting system and the principles,we are trying to find out any possible existing hazards.And some measures are proposed to reduce risks.In the last part of this paper there are some discussions about the safety design of the medical device.
【CateGory Index】: R318.6
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