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)
ISO 17510-1:2007 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.
ISO 17510-1:2007 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 ISO 17510-1:2007.
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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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
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, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 17510-1:2007 has been approved by CEN as a EN ISO 17510-1:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 - Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
All 1, 2, 3
4 6, 12.6
- 6a
This relevant Essential Requirement is
not addressed in this European
Standard
6 13
6 13.6 (h)(2nd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 13.6 (q) This relevant Essential Requirement is
not addressed in this European
Standard
6.1 2, 13.3 a)
6.1 aa) to cc) 13.6 c), d)
6.1 dd) 8.7, 9.1, 13.3, 13.4, 13.5
6.1 dd) 7th dash 13.3 (f) This relevant Essential Requirement is
not fully addressed in this European
Standard
6.1 e) 13.3 (a): This relevant Essential Requirement is
not fully addressed in this European
Standard
6.3 10.2, 10.3, 12.9
6.8.2 13.6 b), c), h), i), l)
6.8.3 13.6 c), d), p), n)
10.1 8.3
10.101, 10.102 4
13, 15, 17, 18,19, 20 12.6
21 5, 9.2, 12.7.1
23 4, 9.2
24 4, 12.7.1
26 12.7.2, 12.7.3
36 4, 9.2, 11.3.1, 12.5
38 13.2, 13.4
39, 40, 41 9.3
42 9.2, 12.7.5
43 7.1, 7.2, 9.3
43.101 7.1, 9.3
44 4, 7.2, 7.3, 7.5, 7.6, 8.1, 8.6
44.6 7.6
44.7 8.3, 8.5
46 9.2, 10.2, 12.8.2, 12.9
48 7.2, 7.5
49 4
49.101 12.8.1, 12.8.2
51 12.8.1, 12.8.2
51.5 2, 12.8.2, 12.9
51.101 12.8.2
51.102 10.1, 10.2, 12.8.2
51.103 10.1, 10.2, 12.8.2
51.104 4, 12.8.1, 12.8.2
51.105 4, 12.8.2
52 12.1
54 7.5 (1st paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
54 7.5 (2nd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 7.5 (3rd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 12.1a) This relevant Essential Requirement is
not addressed in this European
Standard.
54.1 12.1, 12.9
54.101 7.5
56.3 9.1, 12.7.4
56.10 12.9
56.101.1 7.3, 8.1, 8.4
56.101.2 7.3, 8.1, 8.6
56.102 9.1
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this EHSR o 2006/42/EC Qualifying remarks/Notes
EN
- 1.1.4 This relevant EHSR is not addressed in
this European Standard
6.8.2, 56 1.5.4 This relevant EHSR is not fully
addressed in this European Standard
- 1.6.1 This relevant EHSR is not addressed in
this European Standard
- 1.6.2
This relevant EHSR is not addressed in
this European Standard
- 1.6.3 This relevant EHSR is not addressed in
this European Standard
- 3.6.2 This relevant EHSR is not addressed in
this European Standard
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International standard.
INTERNATIONAL ISO
STANDARD 17510-1
Second edition
2007-10-01
Sleep apnoea breathing therapy —
Part 1:
Sleep apnoea breathing therapy
equipment
Thérapie respiratoire de l'apnée du sommeil —
Partie 1: Équipement de thérapie respiratoire de l'apnée du sommeil
Reference number
ISO 17510-1:2007(E)
©
ISO 2007
ISO 17510-1:2007(E)
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ISO 17510-1:2007(E)
Contents Page
Foreword. v
Introduction . vi
1 * Scope. 1
2 Normative references. 1
3 Terms and definitions. 3
4 Requirements. 4
5 Classification and designation. 4
6 Marking, labelling and packaging . 4
7 Power input. 8
8 Basic safety categories. 8
9 Removable protective means . 8
10 Environmental conditions. 8
11 Not used. 9
12 Not used. 9
13 General. 9
14 Requirements related to classification. 9
15 Limitation of voltage and/or energy. 9
16 Enclosures and protective covers . 9
17 S
...
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