有源植入医疗器械核磁共振成像安全性评价方法研究  

Study on Safety Evaluation Methods for Magnetic Resonance Imaging of Active Implantable Medical Devices

作　　者：李澍[1] 郝烨[1] 王权[1] 任海萍[1] Li Shu;Hao Ye;Wang Quan;Ren Haiping(National Institutes for Food and Drug Control, Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国药事》2019年第10期1109-1115,共7页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划(编号2017YFC0111203)

摘　　要：目的:在同样标准、尺度下进行有源植入医疗器械"MR兼容"性评价,确保有源植入医疗器械的使用安全和有效。方法:本文依据ISO/TS 10974:2018标准,结合中国食品药品检定研究院的工作,针对标准中要求的各个试验的试验依据、试验方法、接收准则进行了研究。结果:标准共涉及6项已知或可预见的风险,分别为温升、振动、力、力矩、非预期的刺激以及器械故障。为了评价这些风险,本文介绍了和6项风险相对应的9个试验项目,以此评价有源植入医疗器械的核磁兼容性。结论:目前国内针对有源植入医疗器械核磁兼容性的评价刚刚起步,一些检测手段和方法处在借鉴和摸索之中,本文系统性介绍了评价项目的考虑角度和方法,为国内从事有源植入物核磁兼容性设计及评价者提供参考。Objective: To evaluate the "MR compatibility" of active implantable medical devices under the same standards and scales to ensure the safe and effective use of active implantable medical devices. Methods: According to the ISO/TS 10974: 2018 standard and the work of National Institutes for Food and Drug Control, the test basis, test methods and acceptance criteria of each test required by the standard were studied. Results: Six known or predictable risks which were involved in the standard were found out, namely temperature rise, vibration, force, moment, unexpected stimulus and device failure. In order to evaluate these risks, nine experiments corresponding to six risks were introduced in the paper to evaluate the MR compatibility of active implantable medical devices. Conclusion: At present, the evaluation of MR compatibility of active implantable medical devices in China has just started, and some testing methods are still in the process of exploration. This paper systematically introduces the considerations and methods of evaluation in order to provide references for the design and evaluation of MR compatibility of active implantable medical devices in China.

关 键 词：有源植入性医疗器械 核磁兼容 ISO/TS 10974 

分 类 号：R28[医药卫生—中药学]