Operator’s Manual of Anesthesia System 10 - 3
Product Specifications Standards Compliance
The anesthesia system shall be used together with the monitoring devices, alarm system and
protective devices below:
• The pressure measurement device in compliance with ISO 80601-2-13;
• The pressure restriction device in compliance with ISO 80601-2-13;
• The expiratory volume monitor in compliance with ISO 80601-2-13;
• The breathing system with alarm system in compliance with ISO 80601-2-13;
• The anaesthetic vapour delivery system in compliance with ISO 80601-2-13;
• The anaesthetic gas scavenging system in compliance with ISO 80601-2-13;
• The anesthetic gas delivery device in compliance with ISO 80601-2-13;
• The anesthetic ventilator in compliance with ISO 80601-2-13;
•The O
2
monitor in compliance with ISO 80601-2-55;
•The CO
2
monitor in compliance with ISO 80601-2-55;
• The AG monitor in compliance with ISO 80601-2-55.
The anesthesia system is integrated with the pressure measurement device, pressure restriction
device, expiratory volume monitor, anaesthetic breathing system with alarm system, anaesthetic gas
delivery system, anaesthetic vapour delivery system, anaesthetic ventilator, AG monitor in
compliance with the afore mentioned standards, where:
ISO 10079-3 Third edition 2014-05-01 Medical suction equipment - Part 3: Suction equipment
powered from a vacuum or pressure source
ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 1: Evaluation and testing
within a risk management process
ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 2: Tests for emissions of
particulate matter
ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 3: Tests for emissions of
volatile organic compounds (VOCs)
ISO 17664 Second edition 2017-10 Processing of health care products - Information to be
provided by the medical device manufacturer for the
processing of medical devices
ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent-specific filling systems
TABLE 10-1
(Continued) Standards Compliance
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