Norm

NEN-EN-IEC 60601-2-4:2011 en

Medische elektrische toestellen - Deel 2-4: Speciale eisen voor de veiligheid en essentiële prestaties van hartdefibrilatoren

262,65

Over deze norm

Status Definitief
Aantal pagina's 78
Commissie Medische elektrische toestellen
Gepubliceerd op 01-09-2011
Taal Engels
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. 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 addresses considerations in waveform selection.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-4: Speciale eisen voor de veiligheid en essentiële prestaties van hartdefibrilatoren
Engelse titel Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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