ISO/TC 150/SC 6
| Project No. | ISO 14117:2012 |
|---|---|
| Title | <p>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.</p> <p>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:</p> <p>0 Hz ≤ <i>f</i> < 450 MHz;</p> <p>450 MHz ≤ <i>f</i> ≤ 3 000 MHz.</p> <p>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.</p> |
| Registration number (WIID) | 54472 |
| Scope | <p>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.</p> <p>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:</p> <p>0 Hz ≤ <i>f</i> < 450 MHz;</p> <p>450 MHz ≤ <i>f</i> ≤ 3 000 MHz.</p> <p>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.</p> |
| Status | Atcelts |
| ICS group | 11.040.40 33.100.01 |