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.

CEI EN 60601-2-4

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

active, Most Current
Buy Now
Organization: CEI
Publication Date: 1 May 2012
Status: active
Page Count: 84
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.

Document History

April 1, 2020
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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)....
CEI EN 60601-2-4
May 1, 2012
Medical electrical equipment Part 2: Particular requirements for 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...
August 1, 2004
Medical electrical equipment - Part 2: Particular requirements for the safety of cardiac defibrillators
La Norma contiene prescrizioni che riguardano la sicurezza dei defibrillatori cardiaci destinati a defibrillare il cuore con un impulso elettrico erogato mediante elettrodi applicati o sulla pelle...

References

Advertisement