Standards Development

Scope

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 a 1,5 T (64 MHz) or 3 T (128 MHz), whole body cylindrical MR system, using the fixed (integrated) whole body coil.

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

NOTE 2 The scope is fixed (integrated) whole body coil designs and associated RF exposure limits. However, the generalized methods described in this document are equally applicable for evaluating detachable head or extremity RF transmit coils if justification for the RF exposure levels is provided.

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 3 Modification of these tests for particular device types and confirmation of suitability is left to particular product committees.

NOTE 4 Other interested parties, such as device manufacturers, regulatory agencies, and particular product committees, are responsible for setting specific assessment criteria and the determination of risk.

NOTE 5 Safety requirements for MR scanners can be found in IEC 60601‑2‑33. It provides valuable information regarding the outputs of an MR scanner relevant to AIMDs.

NOTE 6 No consideration has been given to the testing of sensing functionality that might be a part of the intended use of an AIMD. The scope is therefore limited to AIMDs that do not use sensing functions and to AIMDs that have the ability to disable a sensing function during MR scanning that would otherwise be used to affect therapy delivery.