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EN ISO 9919:2005

(Main)

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (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)

Revision of EN 865:1997 (TC Res 320/1999) (CC/000124).

Medizinische elektrische Geräte Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten für den medizinischen Gebrauch (ISO 9919:2005)

Ergänzung:
Diese Besonderen Festlegungen spezifizieren besondere Anforderungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten. Dies beinhaltet alle Teile, die für den bestimmungsgemäßen Gebrauch erforderlich sind, z. B. den Pulsoximetriemonitor, den Pulsoximetrie-sensor, oder das Kabel.
Diese Anforderungen gelten auch für Pulsoximetriegeräte einschließlich Pulsoximetriemonitoren, Puls-oxi-metrie-sensoren und Kabeln, die wiederaufgearbeitet wurden.
Der bestimmungsgemäße Gebrauch von Pulsoximetriegeräten beinhaltet, ist aber nicht begrenzt auf, die Abschätzung der arteriellen Sauerstoffhämoglobinsättigung und Pulsfrequenz bei Patienten innerhalb und außerhalb des Krankenhauses, einschließlich der Anwendung in häuslicher Umgebung.
Pulsoximetriegeräte, die für den Gebrauch in Laborforschungsanwendungen bestimmt sind, und Pulsoximeter, die eine Blutprobe von Patienten benötigen, liegen außerhalb des Anwendungsbereichs dieser Besonderen Festlegungen.
Pulsoximetriegeräte, die für die Überwachung von Ungeborenen bestimmt sind, liegen außerhalb des Anwen-dungs-bereichs dieser Besonderen Festlegungen.
Entfernt aufgestellte oder gekoppelte Geräte, die SpO2-Werte anzeigen und die sich außerhalb der Pati-en-ten-umgebung befinden, liegen außerhalb des Anwendungsbereichs dieser Besonderen Festlegungen.

Appareils électromédicaux - Règles particulières de sécurité et performances essentielles du matériel utilisé pour les oxymètres de pouls à usage médical (ISO 9919:2005)

Elektromedicinska oprema – Posebne zahteve za osnovno varnost in bistvene lastnosti pulznega oksimetra za uporabo v medicini (ISO 9919:2005)

General Information

Status
Withdrawn
Publication Date
14-Mar-2005
Withdrawal Date
07-Apr-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
08-Apr-2009
Completion Date
08-Apr-2009
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 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)

Relations

Replaces
EN 865:1997 - Pulse oximeters - Particular requirements
Effective Date
22-Dec-2008
Replaced By
EN ISO 9919:2009 - 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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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9919:2005
01-junij-2005
1DGRPHãþD
SIST EN 865:2000
Elektromedicinska oprema – Posebne zahteve za osnovno varnost in bistvene
lastnosti pulznega oksimetra za uporabo v medicini (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)
Medizinische elektrische Geräte Besondere Festlegungen für die grundlegende
Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten für den
medizinischen Gebrauch (ISO 9919:2005)
Appareils électromédicaux - Regles particulieres de sécurité et performances
essentielles du matériel utilisé pour les oxymetres de pouls a usage médical (ISO
9919:2005)
Ta slovenski standard je istoveten z: EN ISO 9919:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9919:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9919:2005

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SIST EN ISO 9919:2005



EUROPEAN STANDARD
EN ISO 9919

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2005
ICS 11.040.10 Supersedes EN 865:1997
English version
Medical electrical equipment - Particular requirements for the
basic safety and essential performance of pulse oximeter
equipment for medical use (ISO 9919:2005)
Appareils électromédicaux - Règles particulières de Medizinische elektrische Geräte - Besondere Festlegungen
sécurité et performances essentielles du matériel utilisé für die grundlegende Sicherheit und die wesentlichen
pour les oxymètres de pouls à usage médical (ISO Leistungsmerkmale von Pulsoximetriegeräten für den
9919:2005) medizinischen Gebrauch (ISO 9919:2005)
This European Standard was approved by CEN on 14 February 2005.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.




EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9919:2005: E
worldwide for CEN national Members.

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SIST EN ISO 9919:2005

EN ISO 9919:2005 (E)





Foreword


This document (EN ISO 9919:2005) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
"Respiratory and anaesthetic equipment", the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by September 2005, and conflicting national
standards shall be withdrawn at the latest by September 2005.

This document supersedes EN 865:1997.

This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.



Endorsement notice

The text of ISO 9919:2005 has been approved by CEN as EN ISO 9919:2005 without any
modifications.

2

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SIST EN ISO 9919:2005

EN ISO 9919:2005 (E)



ANNEX ZA
(informative)

R
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

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