医疗机构中医疗器械临床试验的伦理审查  

Ethic Review on Clinical Experiments of Medical Devices in Medical Institutions

作　　者：帅万钧[1] 晁勇 王宁[2] 徐世宁[1] 

机构地区：[1]解放军总医院第一附属医院医学工程科,北京市100048 [2]解放军总医院第一附属医院医务部科训科,北京市100048

出　　处：《中国医疗器械杂志》2011年第4期274-276,共3页Chinese Journal of Medical Instrumentation

摘　　要：医疗器械临床试验是对医疗器械的安全性和有效性按照规定进行试用或验证的过程,该过程需由具有医疗器械临床试验资格的医疗机构审核,经其医学伦理委员会评审通过后,方可进行。对医疗机构中医疗器械临床试验伦理审查的内容、流程和批准标准分别进行了分析和评述,为医疗机构保证临床试验的安全有效提供依据。Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

关 键 词：医疗器械 临床试验 伦理审查 

分 类 号：R197.31[医药卫生—卫生事业管理]