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IEC 60601-2-4 Cardiac Defibrillators and Cardiac Defibrillator Monitors Testing

Medical electrical equipment – Part 2-4: the basic safety and essential performance of cardiac defibrillators

IEC 60601-2-4 Scope:

IEC 60601 2 4 and EN 60601 2 4 testing applies to the basic safety and essential performance of cardiac defibrillators, hereafter referred to as medical electronic equipment.

If a clause or sub-clause is specifically intended to be applicable to medical electronic equipment only, or to medical equipment systems only, the title and content of that clause or sub-clause will say so. If that is not the case, the clause or sub-clause applies both to medical electronic equipment and to medical equipment systems, as relevant. hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of IEC 60601-2-4 are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

EN 60601-2-4 testing 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 [2]2). 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 wave shape, 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 addresses considerations in waveform selection.

Keystone Compliance assists manufacturers with IEC 60601-2-4 and EN 60601-2-4 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-4 test lab needs.