This Technical Specification contains test methods that are applicable to a broad class of active implantable medical devices (AIMDs) for the purpose of evaluating device operation against several hazards. Specifically, the document applies to implantable parts of AIMDs intended to be used in patients who undergo a magnetic resonance scan in 1.5 T, cylindrical bore, whole body MR scanners for imaging the hydrogen nucleus. The type tests that are specified in this report are intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner and can be used to demonstrate device operation according to its MR Conditional labeling.
ANSI/AAMI/ISO TIR10974:2012 history
2013ANSI/AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device