ANSI/AAMI/IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators
This standard specifies 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).
ANSI/AAMI/IEC 60601-2-4:2010 history
2010ANSI/AAMI/IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators