13.5 Standards
Standards - Safety and Functionality
IEC 60601-1 (Class 1, Type B), IEC 60601-1-2, IEC 60601-1-8, ISO
80601-2-13, IEC 62304, ISO 5360
Safety
IEC 60601-1-2Electromagnetic compatibility:
ISO 80601-2-55Respiratory gas monitoring:
ISO 80601-2-13Anesthetic gas delivery
IEC 62366Usability
IEC 60601-1, ISO 80601-2-13Cleaning:
Classification according to IEC 60601-1:
according to the type of protection against electrical shock
Class I equipment:
according to the degree of protection against electrical shock
Type B equipment:
according to the mode of operation (not applicable to the lift, 10%
duty cycle)
Continuous operation:
Classification according to EU Medical Directive 93/42/EEC:
The anesthesia system is classified as IIb.
Classification according to IEC 60529
IPX1
27
Ingress Protection Rating (IP)
27. Valid when the patient cassette is in place and the patient cassette lid is closed. Make sure any fluid has been
wiped from the connections in the vaporizer slots before connecting a vaporizer.
270
FLOW-i 4.2, User's Manual
| 13
| Technical specifications |