SSH EN 865:1997

Pulse oximeters - Particular requirements

Scope

Clause 1 of EN 60601-1 : 1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard 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 applications and "bench" type oximeters that require a blood sample from the patient are outside the scope of this standard.

Related directives

Directives related to this standards.