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Dräger Fabius plus - General safety standards for anesthesia workstations; Relevant standards

Dräger Fabius plus
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Technical data
196 Instructions for use Fabius plus SW 3.n
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
Part 1:
General requirements for safety
IEC 60601-1-2
Medical electrical equipment
Part 1-2:
General requirements for safety, collateral stan-
dard: Electromagnetic compatibility – Requirements
and tests
IEC 60601-1-4
Medical electrical equipment
Part 1-4
General requirements for safety, collateral stan-
dard: Programmable electrical medical systems
IEC 60601-1-8
Medical electrical equipment
Part 1-8:
General requirements for safety, collateral stan-
dard: General requirements, tests, and guidance for
alarm systems in medical electrical systems
IEC 60601-2-13
Medical electrical equipment
Part 2-13:
Particular requirements for the safety of anaesthetic
systems
ISO 8835-2
Systems for inhalational anaesthesia
Part 2:
Anaesthetic breathing systems
ISO 8835-3
Systems for inhalational anesthesia
Part 3:
Transfer and receiving systems of active anesthetic
gas scavenging systems
ISO 8835-4
Systems for inhalational anesthesia
Part 4:
Anesthetic vapor delivery devices
ISO 8835-5
Systems for inhalational anesthesia
Part 5:
Anesthetic ventilators

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