scope:

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 ≤ ƒ < 450 MHz;

450 MHz ≤ ƒ ≤ 3,000 MHz; and

ƒ > 3,000 MHz.