Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
This standard sets forth a comprehensive test methodology for the evaluation of the electromagnetic (EM)
compatibility of active implantable cardiovascular devices (pacemakers and implantable cardioverter defibrillators, or
ICDs).
The standard details test methods appropriate for the interference frequencies at issue. It specifies performance limits
or requires disclosure of performance in the presence of EM emitters, where indicated. In addition, it provides
manufacturers of EM emitters with information about the level of immunity to be expected from active implantable
cardiovascular devices.
This standard addresses the interaction of pacemakers and ICDs with EM emitters operating across the EM
spectrum. It divides the EM frequency spectrum into three discrete segments:
0 Hz ≤∫< 450 MHz;
450 MHz ≤ ∫ ≤ 3,000 MHz; and
∫> 3,000 MHz.