CEI EN 60601-2-4/A1 PDF

This particular standard does not apply to implantable DEFIBRILLATORs, remote control DEFIBRILLATORS, or separate stand-alone cardiac monitors (which are standardized by IEC 60601-2-27:2011 [2]¹). 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. DEFIBRILLATOR electrodes as described in 201.108 can also be used for ECG monitoring; however, due to the larger electrode area, the requirements of IEC 60601-2-27 are not applicable for DEFIBRILLATOR ELECTRODES.

¹ Numbers in square brackets refer to the bibliography.