M00001339
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ISO 14117 1st Edition, July 15, 2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
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Availability date: 07/13/2021
Description / Abstract:
This International Standard 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 ≤ ƒ 450 MHz;
450 MHz ≤ ƒ ≤ 3 000 MHz
This International Standard 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.