ISO 14117:2012
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
- Standard No.
- ISO 14117:2012
- Release Date
- 2012
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 14117:2019
- Latest
- ISO 14117:2019
- Scope
- This International Standard 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 ≤ ƒ < 450 MHz; 450 MHz ≤ ƒ ≤ 3000 MHz This International Standard 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.
ISO 14117:2012 history
- 2019 ISO 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
- 2012 ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
