Standard ISO standard · ISO 14117:2019

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

Status: Valid

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Standard ISO standard · ISO 14117:2019

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

Subjects

Implants for surgery, prosthetics and orthotics (11.040.40) General (33.100.01)


Buy this standard

Standard ISO standard · ISO 14117:2019

Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Subscribe on standards - Read more Dölj
Price: 2 750 SEK
standard ikon pdf

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Price: 2 750 SEK
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Product information

Language: English

Written by: ISO

International title:

Article no: STD-80015459

Edition: 2

Approved: 9/3/2019

No of pages: 134

Replaces: ISO 14117:2012