CSA - CAN/CSA-Z9919-94
Pulse Oximeters for Medical Use - Requirements
| Organization: | CSA |
| Publication Date: | 1 March 1994 |
| Status: | inactive |
| Page Count: | 37 |
scope:
IS0 9919 is one of a series of International Standards based on IEC 601-1; in 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 and object given in clause 1 of IEC 601-1:1988 apply except that 1.1 shall be replaced by the following:
This International Standard specifies requirements for the safety of pulse oximeters, as defined in 1.3.12, intended for use in the approximate measurement of the saturation of human arterial haemoglobin, non-invasively.
The field of application includes, but is not limited to
a) perioperative use;
b) adult critical care application;
c) paediatric and neonatal applications;
d) general determination of saturation on hospitalized and non-hospitalized patients
Pulse oximeters intended for use in laboratory research applications and bench-type oximeters that require a blood sample from the patient are outside the scope of this international Standard
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