EN 865:1997

Pulse oximeters - Particular requirements EN 865:1997

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Mar 15, 2005

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.50   Radiographic equipment

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 865:1997
99.60 Withdrawal effective
Mar 15, 2005

REVISED BY

WITHDRAWN
EN ISO 9919:2005

Relations

Adopted from ISO 9919 NOT_EQUIVALENT