This Standard applies to oxygen analyzers or monitors intended for measuring oxygen levels in a patient's breathing mixture. The field of application for these devices includes clinical situations where oxygen-enriched mixtures may be used (eg, with anaesthesia machines and breathing circuits); critical care, home care, and neonatal ventilators; incubators; oxygen concentrators; and dental analgesia equipment.
This Standard includes requirements for the performance and safety of oxygen analyzers, especially the safety of the sensors and the accuracy of the analyzers. The Standard also includes requirements pertaining to construction, inspection, sterilization or disinfection, servicing, disclosure of information by the manufacturer, and the marking of oxygen analyzers.
This Standard does not apply to oxygen analyzers for use in hyperbaric facilities.
It is not the intent of this Standard to define a program of quality control, incoming inspection, or ongoing maintenance, although specific test methods may also be suitable for such purposes.
Note: The test procedures described in this Standard were developed for use in confirming that a prototype machine complies to this Standard.