System information
System classification
Device standards IEC 60601-1:2005
Device standards IEC 60601-1:1988
2076152-001
This system is classified as follows:
•
Class I Equipment.
•
Type B Equipment.
•
Type BF Equipment (airway modules).
•
Ordinary Equipment
•
Not for use with flammable anesthetics.
•
Continuous operation.
Devices used with this anesthesia system shall comply with the
following standards where applicable:
•
Breathing system and breathing system components ISO
80601-2-13.
•
Anesthetic gas scavenging systems ISO 80601-2-13
•
Anesthetic vapor delivery devices ISO 80601-2-13.
•
Anesthetic agent monitors ISO 80601-2-55.
•
Oxygen monitors ISO 80601-2-55.
•
Carbon dioxide monitors ISO 80601-2-55.
•
Exhaled volume monitors ISO 80601-2-13.
Devices used with this anesthesia system shall comply with the
following standards where applicable:
•
Breathing system and breathing system components ISO
8835-2.
•
Anesthetic gas scavenging systems ISO 8835-3
•
Anesthetic vapor delivery devices ISO 8835-4.
•
Anesthetic agent monitors ISO 21647.
•
Oxygen monitors ISO 21647.
•
Carbon dioxide monitors ISO 21647.
•
Exhaled volume monitors IEC 60601-2-13.
1 Introduction
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