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CEN

EN 865:1997

(Main)

Pulse oximeters - Particular requirements

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.

Pulsoximeter - Besondere Anforderungen

Diese Europäische Norm legt Anforderungen an die Sicherheit von Pulsoximetern fest, die in 3.12 dieser Norm definiert und die zum Gebrauch bei der nichtin- vasiven Näherungsmessung der Sättigung von menschlichem arteriellem Hämeglo- bin bestimmt sind. Der Anwendungsbereich umfasst, ist jedoch nicht beschränkt auf a) Gebrauch während einer Operation; b) Anwendung bei der Intensivpflege von Erwachsenen; c) Anwendungen bei Kindern und Neugeborenen; c) allgemeine Sättigungsbestimmung bei Patienten in oder ausserhalb von Krankenhäusern.

Oxymètres de pouls - Prescriptions particulières

L'article 1 de l'EN 60601-1:1990 s'applique, exception faite du paragraphe 1.1 qui est remplacé par le texte suivant: La présente norme fixe les prescriptions de sécurité des oxymètres de pouls définis en 3.12 des la présente norme, destinés à être utilisés pour mesurer approximativement la saturation de l'hémoglobine artérielle humaine de manière non-invasive.

Pulzni oksimetri - Posebne zahteve

General Information

Status
Withdrawn
Publication Date
18-Feb-1997
Withdrawal Date
14-Mar-2005
ICS
11.040.50 - Radiographic equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-Mar-2005
Completion Date
15-Mar-2005
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 865:2000 - Pulse oximeters - Particular requirements

Relations

Replaced By
EN ISO 9919:2005 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
SIST EN 865:2000
01-januar-2000
Pulzni oksimetri - Posebne zahteve
Pulse oximeters - Particular requirements
Pulsoximeter - Besondere Anforderungen
Oxymetres de pouls - Prescriptions particulieres
Ta slovenski standard je istoveten z: EN 865:1997
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 865:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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