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AAMI/ISO TIR10974:2018

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device


Applies 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.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.


CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

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