Safety and conformity
Safety
IEC 60601-1/EN 60601-1;
The complete classification of the device is as follows:
• Class I type B
• Protection against water penetration: IPX1
• Non sterile device
• Device not suitable in the presence of flammable anaesthetics
• Continuous functioning equipment
EMC
The system meets the Standard IEC 60601-1-2.
Quality Assurance
UNI EN ISO 9001:2008 (Registration n° 387-A Cermet)
UNI EN ISO 13485:2003 (Registration n° 387-M Cermet)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476).
Class IIa
Appendix - Safety and conformity - 37
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