标准摘要
[中文适用范围]： 本文件适用于预期用于接受磁共振（MR）扫描患者的植入式有源植入医疗器械（AIMD），且这些器械的部件在1.5 T圆形或椭圆形横截面孔状全身MR扫描仪中使用，该设备以约64 MHz的频率运行并带有全身体线圈。 NOTE 1：非植入部分的要求超出了本文件范围。本文件规定的试验旨在表征与MR扫描仪相关的磁场和电磁场的相互作用。这些试验可用于证明设备根据其MR条件标签进行操作。然而，这些试验不用于常规测试已制造的产品。 NOTE 2：特定类型设备的特殊测试修改留给具体产品委员会处理。 NOTE 3：其他相关方（如设备制造商、监管机构和具体产品委员会）负责设定具体的符合性准则并确定风险。 NOTE 4：MR扫描仪的安全要求可参考IEC 60601-2-33。 NOTE 5：本范围限于不使用感应功能的AIMD，或者编程为在MR扫描期间不使用感应功能以影响治疗交付的AIMD。 [外文原描述]： 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.
英文名称Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device