Dräger Fabius Tiro - Page 188

Technical data
188 Instructions for use Fabius Tiro SW 3.n
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
ISO 21647
Medical electrical equipment
Particular requirements for the basic safety and
essential performance of respiratory gas monitors
The following also apply for devices manufactured from July 2014 on:
IEC 60601-1 3rd ed.
Medical electrical equipment
Part 1:
General requirements for basic safety and essential
performance
IEC 60601-1-2
Medical electrical equipment
Part 1-2:
General requirements for safety, collateral stan-
dard: Electromagnetic compatibility – Requirements
and tests
IEC 60601-1-8 Part 1-8:
General requirements for basic safety and essential
performance – collateral standard: General require-
ments, tests, and guidance for alarm systems in
medical equipment and medical electrical systems
ISO 80601-2-13
Medical electrical equipment
Part 2-13:
Particular requirements for basic safety and essen-
tial performance of an anaesthetic workstation
Relevant standards (continued)