This National Standard of Canada is equivalent to International Standard IEC 60601-2-4:2002. 1 Scope and object
This clause of the General Standard applies except as follows: *1.1 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, 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.