ISO 14117:2012
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ISO 14117:2012
54472

État actuel : Annulée

Cette norme a été révisée par ISO 14117:2019

Résumé

ISO 14117:2012 specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization.

It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:

0 Hz ≤ f < 450 MHz;

450 MHz ≤ f ≤ 3 000 MHz.

ISO 14117:2012 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.

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