Medical Electrical Equipment Part 2-4: Particular Requirements for the Safety of Cardiac Defibrillators
|Publication Date:||1 August 2002|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
This Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS as defined in 2.1.101, hereinafter referred to as EQUIPMENT.
This Particular Standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS, external transcutaneous pacemakers, or separate stand alone CARDIAC MONITORS (which are standardized by IEC 60601-2-27). 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.
Defibrillation waveform technology is evolving rapidly. Published studies indicate that the effectiveness of waveforms varies. The choice of a particular waveform including waveshape, delivered energy, efficacy, and safety has been specifically excluded from the scope of this standard.
However, due to the critical importance of the therapeutic waveform, comments have been added to the rationale which address considerations in waveform selection.