System Information; System Classification; Device Standards Iec 60601-1:2005; Device Standards Iec 60601-1:1988 - GE Carestation 620 User's Reference Manual

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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
1-17

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