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Technical Data - 1 - ARCOVIS 3000 S/R
Villa Sistemi Medicali
Page 40/40 - Rev.E
[File: 201177-F-00-20.doc]
4. LIST OF THE STANDARDS FOR THE EVALUATION OF
THE PRODUCT COMPLIANCE / ELENCO NORME PER
LA VALUTAZIONE DELLA CONFORMITÀ DEL
PRODOTTO
Reference
Description
Descrizione
MDD 93/42/EEC class IIB
according to Annex IX rule 10.
Medical Devices Directive (EC
mark)
Direttiva Dispositivi Medici
(marcatura CE)
IEC 60601-1 1st edition
Medical devices safety
Sicurezza dei dispositivi medici
IEC 60601-1-2 1st edition
Electromagnetic compatibility
Compatibilità elettromagnetica
IEC 60601-1-3 1st edition
Protection against ionizing radiation
Protezione contro le radiazioni
ionizzanti
IEC 60601-2-7 2nd edition
HV generators
Generatori d’alta tensione
IEC 60601-2-28 1st edition
Tube-housing groups
Complessi tubo - guaina
IEC 60601-2-32 1st edition
Mechanical safety aspects
Aspetti di sicurezza meccanica
ISO 14971:2000
Risk analysis
Analisi dei rischi
CEI EN 60825-1 2nd edition
Laser equipment safety
Sicurezza degli apparecchi laser
ARCOVIS 3000 S/R with radio-protection according to the Standard CEI EN 60601-1-3 (1995)
ARCOVIS 3000 S/R con radioprotezione secondo la Norma CEI EN 60601-1-3 (1995)
Inverter-monobloc group (IN-9040-5 HF + I-40S 3,5 RF, IN-9040-5 HF + I-40R 5 RF) EN60601-2-7:1998
Gruppo Inverter-monoblocco (IN-9040-5 HF + I-40S 3,5 RF, IN-9040-5 HF + I-40R 5 RF) EN60601-2-
7:1998
X-ray group for diagnostics ARCOVIS 3000 S/R IEC 601-2-28 (1993)
Complesso radiante a raggi X per diagnostica ARCOVIS 3000 S/R IEC 601-2-28 (1993)
Complementary unit ARCOVIS 3000 S/R IEC 601-2-32
Apparecchiatura complementare ARCOVIS 3000 S/R IEC 601-2-32
Содержание ARCOVIS 3000 R
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