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BS EN 865:1997- Pulse oximeters. Particular requirements

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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.
Contributor(s):
MFAR - Data Entry Person
Primary Item Type:
British Standard
Identifiers:
ICS 11.040.55 Diagnostic equipment
ISBN 0580279073
Language:
English
Subject Keywords:
Accuracy; Probes (medical instruments); Electrical medical equipment; Electromagnetic compatibility; Electrical safety; Oximeters; Watertightness tests; Equipment safety; Clinical investigation instruments; Medical equipment; Marking; Instructions for use; Dielectric strength; Leakage currents; Drop tests; Alarm systems; Testing conditions; Fire safety; Haemoglobinometers; Performance testing; Haematology
First presented to the public:
6/9/2023
Original Publication Date:
7/15/1997
Previously Published By:
British Standards Institution
Place Of Publication:
London, United Kingdom
Citation:
Extents:
Number of Pages - 16
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2023-06-22 00:37:29.268
Submitter:
Mohd Fadli Abd. Rahman

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BS EN 865:1997- Pulse oximeters. Particular requirements1 2023-06-22 00:37:29.268