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UNE-EN 60601-2-4:2011/A1:2019

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (Endorsed by Asociación Española de Normalización in November of 2019.)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-11-2019

€64.00
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Replace:This particular standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS,external transcutaneous pacemakers, or separate stand-alone cardiac monitors (which are standardizedby IEC 60601-2-27 [2]1). Cardiac monitors which use separate ECG monitoring electrodes are not withinthe scope of this standard unless they are used as the sole basis for AED rhythm recognition detectionor beat detection for synchronized cardioversion.With:This particular standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS, orseparate stand-alone cardiac monitors (which are standardized by IEC 60601-2-27 [2] 2 ). Cardiacmonitors which use separate ECG monitoring electrodes are not within the scope of this standardunless they are used as the sole basis for AED rhythm recognition detection or beat detection forsynchronized cardioversion. Defibrillator electrodes as described in 201.108 can also be used for ECGmonitoring, however due to the larger electrode area, the requirements of IEC 60601-2-27 are notapplicable for defibrillator electrodes.

Committee
CTN 209/SC 62
DocumentType
Amendment
Pages
22
PublisherName
Asociación Española de Normalización
Status
Current

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