Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators
This product standard from the DIN EN 60601-1 (VDE 0750-1) standard series describes the safety requirements for cardiac defibrillators, generally also called “Defis” in German. Implantable or remote control defibrillators, external transcutaneous pacemakers, or separate stand-alone cardiac monitors are not described. Due to the quick evolvement of the defibrillation waveform technology, 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 critical importance of the therapeutic waveform, comments have been added to the rationale which addresses considerations in waveform selection. The responsible committee is Subcommittee UK 812.1 “Diagnostik” (“Diagnostics”) of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.