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现行 ISO TS 10974:2018
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Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device 有源植入式医疗器械患者磁共振成像的安全性评估
发布日期: 2018-04-19
ISO/TS 10974:2018适用于预期用于在1.5 T、圆柱形(圆形或椭圆形横截面)孔、全身MR扫描仪中接受磁共振扫描的患者的有源植入式医疗器械(AIMD)的植入式部件,该扫描仪工作频率约为64 MHz,全身线圈激励。 注1非植入部件的要求超出了本文件的范围。 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。试验可用于根据其MR条件标签证明器械操作。这些试验不用于生产产品的常规试验。 注2特定器械类型的这些试验的修改由特定产品委员会负责。注3其他相关方,如器械制造商、监管机构和特定产品委员会,负责设定特定的合规性标准和确定风险。 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影响MR扫描期间治疗输送的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.
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归口单位: TC 62/SC 62B
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