BS PD ISO/TS 10974:2018-磁共振成像对主动植入式医疗器械患者的安全性评估-国家数字标准馆

现行 BS PD ISO/TS 10974:2018

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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： 2018-04-20

                BS PD ISO/TS 10974:2018适用于主动植入式医疗设备（AIMD）的可植入部件，该设备拟用于在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的频率下工作，全身线圈激励。交叉引用:ASTM F2052IEC 60601-2-33ASTM F2503ASTM F2213ASTM F2182-11aISO 14708-1:2014ISO 27186:2010 Ed 1ASTM F2119-07（2013）ISO 14971:2007IEEE标准C95。3:2002ISO/TR 21900:2017ISO 5841-3购买时可用的所有现行修订版均包含在本文件的购买中。

BS PD ISO/TS 10974:2018 is applicable 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.Cross References:ASTM F2052IEC 60601-2-33ASTM F2503ASTM F2213ASTM F2182 - 11aISO 14708-1:2014ISO 27186:2010 Ed 1ASTM F2119 - 07(2013)ISO 14971:2007IEEE Std C95.3:2002ISO/TR 21900:2017ISO 5841-3All current amendments available at time of purchase are included with the purchase of this document.