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| 医疗器械临床试验方案的制定原则与设计方法 | |
| 引用本文： | 李卫东,陈平,李新章. 医疗器械临床试验方案的制定原则与设计方法[J]. 医疗卫生装备, 2010, 31(6): 83-84,90 |
| 作者姓名： | 李卫东 陈平 李新章 |
| 作者单位： | 1. 解放军254医院放射科,天津,300142 2. 军事医学科学院卫生装备研究所,天津,300161 3. 北京迪康医疗设备有限公司,北京,100094 |
| 摘 要： | 阐述了医疗器械临床试验方案的制定原则和具体的设计方法。通过介绍DC-CR2005计算机X线影像板扫描仪临床试验方案,详细论述了医疗器械临床试验的目的、背景、内容、方法、临床评价标准、临床性能的评价方法和统计处理方法、总体设计等,旨在提供临床试验参考方案,进一步规范医疗器械临床试验行为,提高医疗器械临床试验水平,保证临床试验结果真实、可靠。 |
| 关 键 词： | 医疗器械 临床试验 方案 |
Principle and Method for Establishment of Clinical Trial Scheme of Medical Device |
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| LI Wei-dong,CHEN Ping,LI Xin-zhang. Principle and Method for Establishment of Clinical Trial Scheme of Medical Device[J]. Chinese Medical Equipment Journal, 2010, 31(6): 83-84,90 | |
| Authors: | LI Wei-dong CHEN Ping LI Xin-zhang |
| Affiliation: | 1.Radiology Department,the 254th Hospital of PLA,Tianjin 300142,China;2.Institute of Medical Equipment,Academy of Military Medical Sciences,Tianjin 300161,China;3.Beijing Dikang Medical Equipment Company Ltd,Beijing 100094,China) |
| Abstract: | The principle and method for the establishment of the clinical trial scheme of the medical device are expatiated.Such items of the clinical trial of the medical device are discussed as its objective,background,content,method,clinical evaluation standard,evaluation method statistical processing of clinical performances as well as the overall design,with DC-CR 2005 Computed Radiography System as the subject.The aims include providing medical device clinical trial with a reference scheme,a standardized performance,an enhanced level and a true reliable result. |
| Keywords: | medical device clinical trial scheme |
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