ISO/AWI 24965

EMC for exocardiac implantable cardioverter defibrillators

Scope

This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable exovascular cardiovascular devices that provide one or more therapies for bradycardia, tachycardia, or a combination of both. The scope of this document may include singular (standalone) Exocardiac Implantable Cardioverter Defibrillators and systems of devices incorporating Exocardiac Implantable Cardioverter Defibrillator function.

It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the following range:

0 Hz ≤ ƒ ≤ 3 000 MHz

This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.