ISO 14117:2012 PDF
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Open preview (PDF)Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devicesActive implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 97
- Publication date:
- July 10, 2012
- Edition:
- ISO IS 14117 edition 1 version 1
- ICS:
- 11.040.40
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 ≤ 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.
Technical details
- Technical committee
- ISO/TC 150/SC 6 - Active implants
- SKU
- ISO 14117:2012
