全膝关节假体系统体外功能试验标准及评估方法介绍  

Introduction of in vitro Functional Test Standards and Evaluation Methods of Total Knee Prosthesis System

作　　者：翟豹 张家振 阿茹罕 刘斌 ZHAI Bao;ZHANG Jiazhen;A Ruhan;LIU Bin(Center for Medical Device Evaluation,National Medical Product Administration,Beijing 100081,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京市100081

出　　处：《组织工程与重建外科杂志》2020年第6期530-534,共5页Journal of Tissue Engineering and Reconstructive Surgery

摘　　要：本文对全膝关节假体系统的临床应用和注册时体外功能试验评价的关注点进行了总结。经查阅该领域的相关文献、相关技术标准、产品指导原则等,对全膝关节假体系统的体外功能性评价主要涉及以下方面:各部件耐久性疲劳试验、部件连接可靠性试验、运动与约束研究的相关试验以及产品磨损试验等产品性能的评估。制造商需加强产品的基础研究能力,制定科学的技术指标和试验方法,以确保产品的安全性和有效性,同时也为产品注册申报提供充分的支持性数据。In this paper,the clinical application of the total knee prosthesis system and the concerns of evaluation of in vitro functional tests during registration were summarized.After consulting the related literature in this field,related technical standards,product guidelines,etc.,the in vitro functional evaluation of the total knee prosthesis system mainly involves the following aspects:durability fatigue test of each component,reliability test of component connection,movement and constraint research related tests and product performance evaluation such as product wear test.Manufacturers need to strengthen the basic research capabilities of products,formulate scientific technical indicators and test method to ensure the safety and effectiveness of products,and also provide sufficient supporting data for product registration and declaration.

关 键 词：性能评估 疲劳 磨损 全膝关节假体 

分 类 号：R318.17[医药卫生—生物医学工程]