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现行 AAMI/ISO TIR10974:2018
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Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device 磁共振成像对主动植入式医疗器械患者的安全性评估
发布日期: 2018-05-01
适用于主动植入式医疗设备(AIMD)的可植入部件,拟用于在1.5 T圆柱形(圆形或椭圆形横截面)钻孔中进行磁共振扫描的患者,全身MR扫描仪在约64 MHz下工作,全身线圈激励。本文件中规定的试验是表征与MR扫描仪相关的磁场和电磁场相互作用的型式试验。根据MR条件标记,这些测试可用于演示设备的操作。本试验不适用于制造产品的常规试验。第二版代表了第一版在实践中使用的经验,以及目前对1,5 T(最常见的磁共振场强)相关问题和担忧的理解。
Applies to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic resonance scan in 1,5 T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64 MHz with whole body coil excitation.The tests that are specified in this document are type tests that characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner. The tests can be used to demonstrate device operation according to its MR Conditional labelling. The tests are not intended to be used for the routine testing of manufactured products.This second edition represents experience gained from the first edition of its use in practice and the current understanding of relevant issues and concerns at 1,5 T, the most common MR field strength.
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