UNE EN 60601-2-4:2011/A1:2019
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (Endorsed by Asociación Española de Normalización in November of 2019.)
Equipos electromédicos - Parte 2-4: Requisitos particulares para la seguridad básica y características de funcionamiento esencial de desfibriladores cardiacos. (Ratificada por la Asociación Española de Normalización en noviembre de 2019.)
| Označení normy: | UNE EN 60601-2-4:2011/A1:2019 |
| Počet stran: | 22 |
| Vydáno: | 2019-11-01 |
| Status: | Změna |
UNE EN 60601-2-4:2011/A1:2019
Replace: This particular standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS, external transcutaneous pacemakers, or separate stand-alone cardiac monitors (which are standardized by IEC 60601-2-27 [2]1). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion. With: This particular standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS, or separate stand-alone cardiac monitors (which are standardized by IEC 60601-2-27 [2] 2 ). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion. Defibrillator electrodes as described in 201.108 can also be used for ECG monitoring, however due to the larger electrode area, the requirements of IEC 60601-2-27 are not applicable for defibrillator electrodes.