Practical Aspects of MR Imaging Safety Test Methods for MR Conditional Active Implantable Medical Devices

被引:9
|
作者
Al-Dayeh, Louai [1 ]
Rahman, Mizan [1 ]
机构
[1] Boston Sci Neuromodulat, 25155 Rye Canyon Loop, Valencia, CA 91355 USA
关键词
AIMD; implants; Medical devices; MR imaging safety; ISO/TS; 10974; FIELD;
D O I
10.1016/j.mric.2020.07.008
中图分类号
R8 [特种医学]; R445 [影像诊断学];
学科分类号
1002 ; 100207 ; 1009 ;
摘要
MR imaging of patients with implanted devices has become common, with conditions for safe scanning defined in MR Conditional labeling of the medical device. This resulted from collaboration among medical device manufacturing, MR imaging scanner manufacturing, and regulatory authority communities. These efforts resulted in engineering testing standards and methods that enable evaluation and certification of devices for safe scanning of patients within prescribed MR imaging scanning conditions. This article provides a practical perspective on test methods that address distinct potential patient hazards. It also provides general guidelines for how a clinician might think about potential hazards, and guidance on common misconceptions.
引用
收藏
页码:559 / +
页数:14
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