AS 60601.2.4 PDF

AS 60601.2.4 – Medical electrical equipment, Part 2.4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010 (ED. 3.0), MOD)

The objective of this Standard is to establish particular basic safety and essential performance requirements for cardiac defibrillators. This Standard does not apply to implantable defibrillators, remote control defibrillators, external transcutaneous pacemakers, or separate stand-alone cardiac monitors (which are standardized by AS/NZS IEC 60601.2.27:2016). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this Standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion.