UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

CENELEC - EN 60601-2-4

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

inactive
Organization: CENELEC
Publication Date: 1 August 2011
Status: inactive
Page Count: 80
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

Replacement:

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.

NOTE See also 4.2 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 [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 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.

2 Numbers in square brackets refer to the bibliography.

Document History

August 1, 2011
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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...
EN 60601-2-4
August 1, 2011
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Replacement: 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...
January 1, 2003
Medical electrical equipment Part 2-4: Particular requirements for the safety of cardiac defibrillators
A description is not available for this item.

References

Advertisement