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的频率下以全身线圈激励运行。 注1:非植入零件的要求不在本文件范围内。 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。 注2:特定设备类型的这些测试的修改留给特定的产品委员会。 注3其他相关方，如设备制造商、监管机构和特定产品委员会，负责制定具体的合规标准和确定风险。 注4:MR扫描仪的安全要求见IEC 60601-2-33。 注5:范围仅限于不使用传感功能的AIMD或编程为不使用传感功能以影响MR扫描期间治疗交付的AIMD。

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. NOTE 1 Requirements for non-implantable parts are outside the scope of this document. 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. NOTE 2 Modification of these tests for particular device types is left to particular product committees. NOTE 3 Other interested parties, such as device manufacturers, regulatory agencies, and particular product committees, are responsible for setting specific compliance criteria and determining risk. NOTE 4 Safety requirements for MR scanners can be found in IEC 60601？2？33. NOTE 5 The scope is limited to AIMDs that do not use sensing functions or to AIMDs that are programmed not to use sensing functions to affect therapy delivery during an MR scan.