CAN/CSA-ISO 7767-98 (R2003)
Oxygen Monitors for Monitoring Patient Breathing Mixtures - Safety Requirements (Adopted ISO 7767:1997, second edition, 1997-05-01)
ISO 7767 is one of a series of International Standards based on IEC 601-1 (the General Standard). This type of International Standard is referred to as a Particular Standard. As stated in 1.3 of IEC 601-1:1988, the requirements of this International Standard take precedence over those of IEC 601-1.
The scope given in clause 1 of IEC 601-1:1988 applies except that 1.1 shall be replaced by the following:
This International Standard specifies safety requirements for oxy gen monitors, as defined in clause 1.3.14, intended for use in determining the oxygen level in gas mixtures. Both diverting and non-diverting oxygen monitors are covered.
The field of application includes, but is not limited to:
(a) anaesthetic machines and breathing systems;
(c) infant incubators;
(d) oxygen concentrators.
Devices that do not measure and indicate are not intended to be covered by this International Standard. For instance, a device that has no function other than to signal an alarm at a specific oxygen level would not be considered to be an oxygen monitor for use in direct patient monitoring applications.
The phrase in a gaseous mixture implies that devices that measure or monitor oxygen in a liquid phase (for example, blood gas analyzer or indwelling catheters) are not covered by this International Standard.
Oxygen monitors intended for use in laboratory research applications are outside the scope of this International Standard.