Technical data
General safety standards for anesthesia workstations
Relevant standards
In addition to the standards listed here, this medical
device meets various other standards, e.g., stan-
dards concerning special national requirements.
IEC 60601-1 2nd ed.
Medical electrical equipment
IEC 60601-1-2
Medical electrical equipment
IEC 60601-1-4
Medical electrical equipment
IEC 60601-1-8
Medical electrical equipment
IEC 60601-2-13
Medical electrical equipment
ISO 8835-2
Systems for inhalational anaesthesia
ISO 8835-3
Systems for inhalational anesthesia
ISO 8835-4
Systems for inhalational anesthesia
ISO 8835-5
Systems for inhalational anesthesia
196
Part 1:
General requirements for safety
Part 1-2:
General requirements for safety, collateral stan-
dard: Electromagnetic compatibility – Requirements
and tests
Part 1-4
General requirements for safety, collateral stan-
dard: Programmable electrical medical systems
Part 1-8:
General requirements for safety, collateral stan-
dard: General requirements, tests, and guidance for
alarm systems in medical electrical systems
Part 2-13:
Particular requirements for the safety of anaesthetic
systems
Part 2:
Anaesthetic breathing systems
Part 3:
Transfer and receiving systems of active anesthetic
gas scavenging systems
Part 4:
Anesthetic vapor delivery devices
Part 5:
Anesthetic ventilators
Instructions for use Fabius plus SW 3.n