Dräger Fabius GS premium Instructions For Use Manual page 192

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Technical data
Relevant standards (continued)
ISO 21647
Medical electrical equipment
The following also apply for devices manufactured from July 2014 on:
IEC 60601-1 3rd ed.
Medical electrical equipment
IEC 60601-1-2
Medical electrical equipment
IEC 60601-1-8
ISO 80601-2-13
Medical electrical equipment
ISO 80601-2-55
192
Particular requirements for the basic safety and
essential performance of respiratory gas monitors
Part 1:
General requirements for basic safety and essential
performance
Part 1-2:
General requirements for safety, collateral stan-
dard: Electromagnetic compatibility – Requirements
and tests
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
Part 2-13:
Particular requirements for basic safety and essen-
tial performance of an anaesthetic workstation
Part 2-55:
Particular requirements for basic safety and essen-
tial performance of respiratory gas monitors
Instructions for use Fabius GS premium SW 3.n

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