This consolidated version includes Amendment 1 which updates references and clarifies the scope as well as provides additional information for AEDs, defibrillator electrodes, audible warnings and cables.
AAMI/IEC 60601-2-4 concerns the basic safety and essential performance of medical electrical equipment intended to defibrillate the heart by an electrical pulse via electrodes applied either to the patient's skin (external electrodes) or to the exposed heart (internal electrodes). This standard does not apply to implantable defibrillators, remote control defibrillators, external transcutaneous pacemakers, or separate cardiac monitors. This standard amends and supplements IEC 60601-1 (third edition, 2005).