血管内介入器械扭转性能评价方法研究  

Study on the Evaluation Method of Torsional Performance of Endovascular Interventional Devices

作　　者：彭思睿 吴娟洁 王书晗 PENG Si-rui;WU Juan-jie;WANG Shu-han(Shenzhen Institute For Drug Control(Shenzhen Testing Center of Medical Devices),Guangdong Shenzhen 518057)

机构地区：[1]深圳市药品检验研究院(深圳市医疗器械检测中心),广东深圳518057

出　　处：《中国医疗器械信息》2023年第19期19-21,共3页China Medical Device Information

基　　金：高风险医疗器械可沥滤物研究及标准化科技创新团队(项目编号:2021TDB29);手术机器人临床前动物实验评价科技创新团队(项目编号:2022TDB51);血液接触类医疗器械/材料涂层牢固度评价方法研究科技创新团队(项目编号:2022TDB52)。

摘　　要：为满足血管内介入器械扭转性能测试需求,设计测试方法,尝试完善现有评价体系。根据现阶段常规介入器械产品对扭转指标的适用性及测试方法作讨论,从风险分析、器械预期作用等角度设计了扭转结合强度及扭控性能两个测试方法,给出测试参数、细节与接受准则。所述方法满足目前常见介入器械的测试需要,为该类产品扭转性能体外试验研究提供了参考。To meet the requirements for testing the torsional performance of vascular interventional devices,design testing methods and try to improve the existing evaluation system.According to the applicability of torsional indicators and testing methods of conventional interventional devices at the current stage,discussions were held from the perspectives of risk analysis,device expected use,etc.Two testing methods were designed:torsional binding strength testing and torsional performance testing.Test parameters,details and acceptance criteria were provided.The methods can meet the testing requirements of common interventional instruments,providing a reference for in vitro torsional performance testing of such products.

关 键 词：介入器械 扭转性能 扭转结合强度 

分 类 号：TH789[机械工程—仪器科学与技术]