Dräger Primus Infinity Empowered - Relevant Standards

Technical data
270
Instructions for use Primus Infinity Empowered SW 4.5n
Relevant standards
In addition to the standards listed here, ther medical device also complies with various other standards,
e.g., standards concerning special national requirements.
IEC 60601-1 2nd ed.
Medical electrical equipment
Part 1:
Requirements for safety
IEC 60601-1-2
Medical electrical equipment
Part 1-2:
General requirements for safety
Collateral standard: Electromagnetic compatibility; Require-
ments and tests
IEC 60601-1-8
Medical electrical equipment
Part 1-8:
General requirements for safety
Collateral standard: General requirements, tests and guid-
ance 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 sys-
tems
ISO 8835-3
Systems for inhalational anaesthesia
Part 3:
Transfer and receiving systems of active anaesthetic gas
scavenging systems
ISO 8835-4 Part 4:
Anaesthetic vapour delivery devices
ISO 8835-5
Systems for inhalational anaesthesia
Part 5:
Anaesthetic ventilators
ISO 9919
Medical electrical equipment
Particular requirements for basic safety and essential per-
formance of pulse oximeter equipment for medical use
ISO 21647
Medical electrical equipment
Particular requirements for basic safety and essential per-
formance of respiratory 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 perform-
ance
IEC 60601-1-2
Medical electrical equipment
Part 1-2:
General requirements for safety
Collateral standard: Electromagnetic compatibility; Require-
ments and tests