AAMI - PC76
Active implantable medical devices—Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
|Publication Date:||1 January 2021|
This document is applicable to transvenous pacemaker, ICD, and CRT systems 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 magnetic resonance (MR) scanners operating at approximately 64 MHz with whole body coil excitation.
The tests that are specified in this document 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. Some of the tests are type tests whereas others require sample size justification.
The scope of this document is limited to:
- systems that do not use sensing functions or that are programmed not to use sensing functions to affect therapy delivery during an MR scan;
- systems which have high voltage therapy disabled during an MR scan;
- devices which are implanted in the pectoral region of patients.
Requirements for non-implantable parts are outside the scope of this document.
The requirements of this document supplement or modify those of AAMI/ISO TIR10974.
NOTE 1 The document might provide useful guidance for newer therapies such as subcutaneous ICD systems, leadless pacemakers, and loop recorders, but their requirements are outside the scope of this document.
NOTE 2 Safety requirements for MR scanners can be found in IEC 60601-2-33.