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
| Standard number: | BS ISO 14117:2019 - TC |
| Released: | 2020-02-24 |
| ISBN: | 978 0 539 07754 4 |
| Status: | Tracked Changes |
BS ISO 14117:2019 - TC
This standard 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 is classified in these ICS categories:
- 11.040.40 Implants for surgery, prosthetics and orthotics
- 33.100.01 Electromagnetic compatibility in general
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.
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:
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0 Hz ? ƒ < 385 MHz;
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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.