ISO/TS 10974:2012 带有有源植入性医疗器械的病人磁共振成像的安全评定

标准编号：ISO/TS 10974:2012

中文名称：带有有源植入性医疗器械的病人磁共振成像的安全评定

英文名称：Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

发布日期：2012-05

标准范围

ISO/TS 10974:2012适用于主动植入式医疗设备（AIMD）的可植入部件，该设备拟用于可能在1.5T圆柱孔全身MR扫描仪中进行磁共振扫描的患者，用于氢原子核成像。ISO/TS 10974:2012中规定的试验是对设备样品进行的型式试验，以表征与MR扫描仪相关的磁场和电磁场的相互作用。ISO/TS 10974:2012包含适用于一大类AIMD的测试方法，目的是评估针对几种危险的设备操作。

ISO/TS 10974:2012 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who might undergo a magnetic resonance scan in 1,5T, cylindrical bore, whole body MR scanners for imaging the hydrogen nucleus.The tests that are specified in ISO/TS 10974:2012 are type tests intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner.ISO/TS 10974:2012 contains test methods that are applicable to a broad class of AIMDs for the purpose of evaluating device operation against several hazards.

标准预览图