scope:

Addition:

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, 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.

This specification defines minimum pad electrode performance. It does not ensure compatibility of a particular pad electrode-defibrillator combination nor does it ensure an acceptable level of performance. While it provides reasonable assurance of safe performance, it does not ensure compatibility of a particular pad electrode-defibrillator combination. As such, the consumer should request compatibility test information from the manufacturer(s).