SIST EN ISO 17510-1:2009
(Main)Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for
domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.
This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes
equipment intended for use with neonates.
Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.
This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including:
⎯ ISO 10651-2:2004;
⎯ ISO 10651-3:1997;
⎯ ISO 10651-4:2002;
⎯ ISO 10651-5:2006;
⎯ ISO 10651-6:2004.
This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12.
ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks
and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also
Figure AA.1.
Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe-Atemtherapiegeräte (ISO 17510-1:2007)
IEC 60601-1:1988, Abschnitt 1, gilt mit folgender Ausnahme.
Änderung (am Ende des Unterabschnitts 1.1 ergänzen):
Dieser Teil von ISO 17510 legt Anforderungen an Geräte fest, die für die Schlafapnoe-Atemtherapie im
häuslichen Bereich, in Schiffen, Luftfahrzeugen und anderen Transportfahrzeugen und in Einrichtungen des
Gesundheitswesens vorgesehen sind.
Dieser Teil von ISO 17510 gilt für zum Gebrauch bei Erwachsenen und Kindern vorgesehene Geräte und
schließt für die Anwendung bei Neugeborenen vorgesehene Geräte aus.
Jet- und Hochfrequenzbeatmung und Oszillation werden in diesem Teil dieses Dokuments nicht berücksichtigt.
Dieser Teil von ISO 17510 gilt nicht für Geräte, die im Anwendungsbereich der Normenreihe ISO 10651
liegen, einschließlich:
- ISO 10651-2:2004;
- ISO 10651-3:1997;
- ISO 10651-4:2002;
- ISO 10651-5:2006;
- ISO 10651-6:2004.
Dieser Teil von ISO 17510 behandelt keine Geräte, die in den Anwendungsbereich von IEC 60601-2-12:2001
fallen.
ISO 17510 behandelt Schlafapnoe-Atemtherapiegeräte für die Anwendung am Patienten. ISO 17510-2 gilt für
Masken und das Zubehör, das zur Verbindung eines Schlafapnoe-Atemtherapiegeräts mit dem Patienten
verwendet wird. Siehe auch Bild AA.1.
Thérapie respiratoire de l'apnée du sommeil - Partie 1: Équipement de thérapie respiratoire de l'apnée du sommeil (ISO 17510-1:2007)
L'ISO 17510-1:2007 spécifie les exigences relatives aux équipements destinés à la thérapie respiratoire de l'apnée du sommeil pour un usage à domicile, sur les bateaux, les avions et autres véhicules de transport ainsi que dans les établissements hospitaliers.
L'ISO 17510-1:2007 s'applique aux équipements destinés aux adultes et aux enfants, à l'exclusion des équipements destinés aux nouveaux-nés.
La ventilation et l'oscillation par injection et à très haute fréquence ne sont pas traitées dans l'ISO 17510-1:2007.
Zdravljenje dihanja pri prenehanju dihanja v spanju - 1. del: Oprema za zdravljenje prenehanja dihanja v spanju (ISO 17510-1:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 17510-1:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 17510-1:2008
Zdravljenje dihanja pri prenehanju dihanja v spanju - 1. del: Oprema za zdravljenje
prenehanja dihanja v spanju (ISO 17510-1:2007)
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
(ISO 17510-1:2007)
Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe-Atemtherapiegeräte (ISO 17510-
1:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 1: Équipement de thérapie
respiratoire de l'apnée du sommeil (ISO 17510-1:2007)
Ta slovenski standard je istoveten z: EN ISO 17510-1:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 17510-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 17510-1:2009
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SIST EN ISO 17510-1:2009
EUROPEAN STANDARD
EN ISO 17510-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 17510-1:2007
English Version
Sleep apnoea breathing therapy - Part 1: Sleep apnoea
breathing therapy equipment (ISO 17510-1:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 1: Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe-
Équipement de thérapie respiratoire de l'apnée du sommeil Atemtherapiegeräte (ISO 17510-1:2007)
(ISO 17510-1:2007)
This European Standard was approved by CEN on 24 February 2009.
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 CEN Management Centre 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 CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510-1:2009: E
worldwide for CEN national Members.
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SIST EN ISO 17510-1:2009
EN ISO 17510-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 17510-1:2009
EN ISO 17510-1:2009 (E)
Foreword
The text of ISO 17510-1:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 17510-1:2009 by 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 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 17510-1:2007.
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 EC Directive.
For relationship with EC Directive, 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, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherl
...
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