CELAB effettua prove su dispositivi medici e per estetica inerenti la marcatura CE.
La norma CEI EN 60601 è il riferimento normativo riguardo la sicurezza elettrica degli apparecchi elettromedicali.
Le prove che si possono effettuare comprendono i test di:
EN 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
EN 60601-1-2: Electromagnetic compatibility
EN 60601-1-6: Usability
EN 60601-1-8: Alarm Systems
EN 60601-1-10: Requirements for the development of physiologic closed-loop controllers
EN 60601-1-11: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EN 60601-2-X: Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance
Comprese tutte le norme della serie:
EN ISO 14971: Application of risk management to medical devices
MDD 93/42/EEC: Medical Device Directive