Specifications
Instructions for Use Apollo SW 4.5n 309
Part Number: 9053586, 3rd edition
ISO 9919
Medical electrical equipment
Particular requirements for basic safety and essential performance of pulse
oximeter equipment for medical use
ISO 21647
Medical electrical equipment
Particular requirements for basic safety and essential performance of respi-
ratory gas monitors
For devices from production date July 2015 the following also applies:
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 standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-8 Part 1-8:
General requirements for safety including essential performance character-
istics - Collateral standard: Alarm systems - General requirements, tests
and guidance for alarm systems in medical electrical equipment and medi-
cal electrical systems
ISO 80601-2-13
Medical electrical equipment
Part 2-13:
Particular requirements for basic safety and essential performance of an an-
aesthetic workstation
ISO 80601-2-55 Part 2-55:
Particular requirements for the basic safety and essential performance of
respiratory gas monitors