Technical data
414
Instructions for use Zeus Infinity Empowered SW 2.n
General safety standards for anesthesia workstations
Relevant standards
In addition to the standards listed here, this medi-
cal device meets various other standards, e.g.,
standards concerning special national require-
ments.
IEC 60601-1 2nd edition
Medical electrical equipment
Part 1:
General requirements for safety
IEC 60601-1-2
Medical electrical equipment
Part 1-2:
General requirements for safety, Collateral stand-
ard: Electromagnetic compatibility requirements
and tests
IEC 60601-1-4
Medical electrical equipment
Part 1-4
General requirements for safety, Collateral stand-
ard: Programmable medical electrical systems
IEC 60601-1-8
Medical electrical equipment
Part 1-8:
General requirements for safety, Collateral stand-
ard: 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 and essential
performance of anesthetic systems
ISO 8835-2
Systems for inhalation anesthesia
Part 2:
Anesthesia breathing systems
ISO 8835-3
Systems for inhalation anesthesia
Part 3:
Transfer and receiving systems of active anaes-
thetic gas scavenging systems
ISO 8835-4
Systems for inhalation anesthesia
Part 4:
Anesthetic vaporizers
ISO 8835-5
Systems for inhalation anesthesia
Part 5:
Anesthesia ventilators
ISO 21647
Medical electrical equipment
Particular requirements for the basic safety and es-
sential performance of respiratory gas monitors
EN 1060-1 Non-invasive blood pressure measuring equipment