CAJ | 학술논문

在国外技术成熟度等级(TRL)描述的基础上,参考美国国防部和北约的医疗器械TRL等级定义和描述,通过文献分析、专家咨询等方法,结合我国先进医疗器械的研发和审批特点,尝试构建适用于我国先进医疗器械技术成熟度评价的TRL等级定义和描述.
재국외기술성숙도등급(TRL)묘술적기출상,삼고미국국방부화북약적의료기계TRL등급정의화묘술,통과문헌분석、전가자순등방법,결합아국선진의료기계적연발화심비특점,상시구건괄용우아국선진의료기계기술성숙도평개적TRL등급정의화묘술.
Technology readiness level (TRL) refers the general maturity level of a single technology or technical systems (including technology,component or subsystem) during the process of development.Base on the original TRL proposed by NASA,with reference to medical device TRL modified by US Department of Defense and NATO,this study modified TRL definition and description for advanced medical devices with consideration of R&D,review and approval characteristics of advanced medical devices in China.