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《China Medical Equipment》 2013-01
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Methods and significance of reevaluation of medical device quality

ZHANG En-ke, WU Zhuo, XUE Hong,et al Department of Equipment Management, Shannxi Provincial People's Hospital, Xi'an 710068, China.  
Reevaluation of medical device quality is an important part of the medical equipment quality control system. In this paper, the authors introduced the methods for the reevaluation based on the situation of low quality of medical devices used in medical institutions in China. Meanwhile, we explored the establishment of the system of the reevaluation through the angles of strengthening quality standards, constructing technical specifications and emphasizing monitoring of adverse events. It proved that the reevaluation of medical device quality in medical institutions is very important for quality control of the devices.
【CateGory Index】: R197.39
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