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ANSI/AAMI/ISO 14117:2019

Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

Specifies a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable cardiovascular devices. The devices addressed by this standard include those that provide one or more therapies for bradycardia, tachycardia, and cardiac resynchronization. This document details test methods appropriate for the interference frequencies at issue. It specifies performance limits or requires disclosure of performance in the presence of EM emitters, where indicated.

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Association for the Advancement of Medical Instrumentation [AAMI]


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