scope:

Specifies requirements for the safety of pulse oximeters, as defined in 3.12 of this standard, 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 hospitalised and non-hospitalised patients. Pulse oximeters intended for use in laboratory research appliations and "bench" type oximeters that require a blood sample from the patient are outside the scope of this standard.