ISO 14117:2019

$55.25

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

Published By	Publication Date	Number of Pages
ISO	2019-09	144

Guaranteed Safe Checkout

Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, 33.100.01 - Electromagnetic compatibility in general, ISO

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2019-09
Pages Count	144
Language	English
Edition	2
File Size	12.6 MB
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics 33.100.01 - Electromagnetic compatibility in general

Preview PDF


PDF Format	Searchable	Printable	Preview Now

ISO 14117:2019

Related products