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CEI EN 60601-2-4

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

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Organization: CEI
Publication Date: 1 April 2020
Status: active
Page Count: 22
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

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.

Document History

CEI EN 60601-2-4
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)....
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

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