16 requisiti legali e normativi, Requisiti legali e normativi – Welch Allyn Spiroperfect - User Manual Manuale d'uso
Pagina 84

CardioPerfect Workstation
Modulo SpiroPerfect
– Manuale dell'utente
DIR 80012359 Ver. F
84 / 98
16 Requisiti legali e normativi
MDD - Medical Device Directive (MDD) 93/42/EEC
IEC/EN 60601-1-1, Medical Electrical Equipment, General Requirements for safety, Safety
requirements for medical electrical systems.
IEC/EN 60601-1 Medical Electrical Equipment
– General Requirements for Safety
IEC 60601-1-2 Medical Electrical Equipment - Safety Requirements - EMC
IEC/EN 60601-1-4 Collateral Standard for Programmable Medical Systems
CAN/CSA C22.2 No. 601.1-M90/UL 60601-1, Medical Electrical Equipment
– General
Requirements for Safety
Rappresentante Affari Regolatori
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland
4341 State Street Road
Skaneateles Falls, NY 13153 USA
Tel: 800 535-6663 (North America Only) or 315 685-4560
Fax: 315 685-3361
www.welchallyn.com