PD ISO/TS 10974:2012

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. | Status: Superseded, Withdrawn

1 Scope This Technical Specification 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 bore, whole body MR scanners for imaging the hydrogen nucleus.

NOTE 1 Requirements for non-implantable parts are outside the scope of this Technical Specification.

The tests that are specified in this Technical Specification are type tests intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner. They 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. This Technical Specification contains test methods that are applicable to a broad class of AIMDs for the purpose of evaluating device operation against several hazards (see Clause 7). Tests for particular device types are not included. Specific compliance criteria and the determination of risk resulting from device behavioural response during these tests are outside the scope of this Technical Specification.

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 All safety requirements for MRI scanners can be found in IEC 60601‑2‑33.