EN ISO 17510-1:2007

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment (add at the end of the Subclause 1.1): 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 berück-sichtigt.
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 Anhang AA.1.

Thérapie respiratoire de l'apnée du sommeil - Partie 1: Équipement de thérapie respiratoire de l'apnée du sommeil (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

• Status: Withdrawn
• Publication Date: 30-Sep-2007
• Withdrawal Date: 10-Mar-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: 11-Mar-2009
• Completion Date: 11-Mar-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 17510-1:2008 - Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

Relations

• Replaces: EN ISO 17510-1:2002/AC:2003 - Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002)
• Effective Date: 22-Dec-2008
• Replaces: EN ISO 17510-1:2002 - Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 17510-1:2009 - Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
• Effective Date: 23-Mar-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2008
1DGRPHãþD
SIST EN ISO 17510-1:2002
SIST EN ISO 17510-1:2002/AC:2004
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: Equipements de thérapie
respiratoire de l'apnée du sommeil (ISO 17510-1:2007)
Ta slovenski standard je istoveten z: EN ISO 17510-1:2007
ICS:
11.040.10
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 17510-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2007
ICS 11.040.10 Supersedes EN ISO 17510-1:2002
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 30 September 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510-1:2007: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Annex ZA (informative)  Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 17510-1:2007) 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 April 2008, and conflicting national standards shall be withdrawn at the
latest by April 2008.
This document supersedes EN ISO 17510-1:2002.
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(s).
For relationship with EC 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, 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 17510-1:2007 without any
modification.
Annex ZA
(informative)
Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC
This Document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices (Medical Device Directive).
Once this document 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
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Corresponding essential Qualifying remarks/Notes
this document requirement of Directive 93/42/EEC
All 1, 2, 3
4 6, 12.6
6 13
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
6.3 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
54.1 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
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 Separation. 9
18 Protective earthing, functional earthing and potential equalization . 9
19 Continuous leakage currents and patient auxiliary currents. 9
20 Dielectric strength. 10
21 Mechanical strength. 10
22 Moving parts. 10
23 Surfaces, corners and edges. 10
24 Stability in normal use. 10
25 Expelled parts. 10
26 * Vibration and noise . 10
27 Pneumatic and hydraulic power. 11
28 Suspended masses. 11
29 X-radiation. 11
30 Alpha, beta, gamma, neutron radiation and other particle radiation . 11
31 Microwave radiation. 11
32 Light radiation (including lasers) . 12
33 Infra-red radiation . 12
ISO 17510-1:2007(E)
34 Ultra-violet radiation . 12
35 Acoustical energy (including ultra-sonics) . 12
36 Electromagnetic compatibility. 12
37 Locations and basic requirements.
...