STANDARD
ISO 14117:2019
Issue date: 2019 09 03
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
This document 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 in conjunction with transvenous lead systems.
NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
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 ≤ ? < 385 MHz;
— 385 MHz ≤ ? ≤ 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.
General information on ISO 14117:2019
Timeline
An overview of the development of ISO 14117:2019 from 2012 til today.
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ISO 14117:20192019 09 03 Standard ISO 14117:2019, Edition: 2019 09 03Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implanta...
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ISO 14117:20122012 07 10 Standard ISO 14117:2012, Edition: 2012 07 10Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implanta...
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