血管内超声光学相干断层同步成像系统在新标准体系下的质控评价研究  

Study on Quality Control Evaluation of the Intravascular Ultrasound Optical Coherence Tomography Synchronous Imaging System Under the New Standard System

作　　者：王权[1] 李澍[1] 党徽 郝烨[1] 张超[1] 李佳戈[1] WANG Quan;LI Shu;DANG Hui;HAO Ye;ZHANG Chao;LI Jiage(Institute for Medical Device Control,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院医疗器械检定所,北京100050

出　　处：《中国医疗设备》2021年第8期11-14,共4页China Medical Devices

基　　金：国防科技创新特区163计划12-27重点项目(20-163-12-ZD-027-013-04)。

摘　　要：目的分析血管内超声光学相干断层扫描(Intravascular Ultrasound-Optical Coherence Tomography,IVUS-OCT)成像系统性能指标和电气安全的系统容易出现的风险,研究对应的质量评价方法,以加强对IVUS-OCT成像系统进行有效性及安全性的质量评价和风险控制。方法通过对成像半径、分辨力及几何位置精度等性能指标的检测评价研究,结合实际检验工作,设计性能评价的测试体模。通过对安规标准的解读,重点从质量评价层面分析主要风险点和评价原则。结果IVUSOCT成像系统作为一种特殊的高风险医用电气设备或医用电气系统,从产品设计阶段就要全方面考虑系统的安全性和有效性,要特别注意电击危险的防护问题、超温问题和电磁兼容问题。结论通过对IVUS-OCT成像系统实际检测过程中的问题分析,探索对应质量风险点的质控方法,为今后此类产品的检测和监管提出思路。Objective To analyze the performance index of intravascular ultrasound optical coherence tomography(IVUS-OCT)system and the risk of electrical safety system,and study the corresponding quality evaluation methods,so as to strengthen the quality evaluation and risk control of effectiveness and safety of IVUS-OCT system.Methods Through the research on the performance evaluation of imaging radius,resolution,and geometric position accuracy,combined with the daily inspection work,the test phantom of performance evaluation was designed.Through the interpretation of safety regulation standards,the main risk points and evaluation principles were analyzed from the perspective of quality evaluation.Results As a special high-risk medical electrical system,IVUS-OCT system should consider the safety and effectiveness of the system in all aspects from the product design stage.Special attention should be paid to the protection of electric shock,overheating and electromagnetic compatibility.Conclusion Through the analysis of the problems in the actual testing process of IVUS-OCT system the quality control methods corresponding to the quality risk points are explored,and the ideas for the future detection and supervision of such products are put forward.

关 键 词：血管内超声诊断设备 光学相干断层扫描 风险分析 质量评价 有源医疗器械 

分 类 号：R197.39[医药卫生—卫生事业管理]