CAN/CSA-Z9919-94 (R2004)

Preface

ISO 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.