PD ISO/TS 10974:2018

This document is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic resonance scan in 1,5T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64MHz with whole body coil excitation.

NOTE1 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.

NOTE2 Modification of these tests for particular device types is left to particular product committees.

NOTE3 Other interested parties, such as device manufacturers, regulatory agencies, and particular product committees, are responsible for setting specific compliance criteria and determining risk.

NOTE4 Safety requirements for MR scanners can be found in IEC60601-2-33.

NOTE5 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.