医疗器械临床试验方案的制定原则与设计方法

Principle and Method for Establishment of Clinical Trial Scheme of Medical Device

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。

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.