ISO 14117:2012

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

Publication date:   Jul 10, 2012

95.99 Withdrawal of Standard   Sep 3, 2019

General information

95.99 Withdrawal of Standard   Sep 3, 2019

ISO

ISO/TC 150/SC 6 Active implants

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics | 33.100.01   Electromagnetic compatibility in general

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO 14117:2012
95.99 Withdrawal of Standard
Sep 3, 2019

REVISED BY

PUBLISHED
ISO 14117:2019