SR EN 865:2003

Pulse oximeters - Particular requirements

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.

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General information

Status : Withdrawn
Approval date : 10/10/2003
Publish date : 10/11/2003
Withdrawal date : 9/30/2005
Number of pages : 44
ICS : 11.040.50 Radiographiic equipment
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaced by SR EN ISO 21647:2005