ISO/AWI 24965
Resumen
This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable exovascular cardiovascular devices that provide one or more therapies for bradycardia, tachycardia, or a combination of both. The scope of this document may include singular (standalone) Exocardiac Implantable Cardioverter Defibrillators and systems of devices incorporating Exocardiac Implantable Cardioverter Defibrillator function. It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the following range: 0 Hz ≤ ƒ ≤ 3 000 MHz This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
Informaciones generales
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Estado: En desarrolloEtapa: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
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Edición: 1
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Comité Técnico :ISO/TC 150/SC 6
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