BS EN 60601-2-4:2003 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of cardiac defibrillators
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 DEFIBRIL-LATORS, 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.
BS EN 60601-2-4:2003 history
2019BS EN 60601-2-4:2011+A1:2019 Medical electrical equipment - Particular requirements for the basic safety and essential performance of cardiac defibrillators
2011BS EN 60601-2-4:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of cardiac defibrillators
2003BS EN 60601-2-4:2003 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of cardiac defibrillators