TRL及其在我国医疗器械技术成熟度评价中的应用探讨  

Discussion on TRL and Its Application in Medical Devices Technology Maturity Assessment in China

作　　者：周平[1] 欧阳昭连[1] 池慧[1] 

机构地区：[1]中国医学科学院/北京协和医学院医学信息研究所/图书馆,北京100020

出　　处：《医学信息学杂志》2015年第5期52-56,共5页Journal of Medical Informatics

基　　金：国家科技支撑计划"专用超声诊断探头部件及系统研发"(项目编号:2012BAI13B02);中央级公益性科研院所基本科研业务费"先进医疗器械技术成熟度评价方法探索"(项目编号:14R0101)

摘　　要：介绍TRL的提出及其在医疗领域的实际应用,结合医疗器械的生产、使用和监管特点,分析TRL应用于医疗器械技术成熟度评价应考虑的安全性、有效性和上市监管等问题。阐述美国国防部和北约组织TRL等级定义和描述,指出TRL应用于医疗器械技术成熟度评价切实可行,可作为研发管理和技术交流工具减少技术风险,及时评价项目进度。The paper introduces the history of TRL （Technology Readiness Level） and its application in technology maturity assess- ment in the medical field, combining with the production, utilization and supervision characteristics of medical devices, it analyzes the security, validity and listing supervision problems of applying TRL to assess technology maturity of medical devices. The study also elabo-rates the TRL level definition and description proposed by US Department of Defense and NATO. It is feasible to apply TRL for technology maturity assessment of medical devices. TRL is an efficient R＆D management tool and technology communication tool which can miti- gate technical risks, assess R＆D progress and accelerate successful development of medical devices.

关 键 词：TRL 医疗器械 技术成熟度 

分 类 号：R197.39[医药卫生—卫生事业管理]