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  • BSI
    BS ISO 14117:2019 - TC Tracked Changes. Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    Edition: 2020
    $798.15
    / user per year

Description of BS ISO 14117:2019 - TC 2020

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 ?  ƒ < 385 MHz;

  • 385 MHz ?  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.



Standard NumberBS ISO 14117:2019 - TC
TitleTracked Changes. Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
StatusUnder Review
Publication Date2020-02-24
DescriptorsSafety measures, Defibrillators, Electrical impedance, Prosthetic devices, Implants (surgical), Cardiology, Pulse circuits, Signal generators, Electrical medical equipment, Type testing, Medical equipment, Pulse generators, Heart
ICS11.040.40 Implants for surgery, prosthetics and orthotics, 33.100.01 Electromagnetic compatibility in general
CommitteeCH/150/2
ISBN978 0 539 07754 4
PublisherBSI
Pages0

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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