EN ISO 17510-2:2009

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

ISO 17510-2:2007 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear.
ISO 17510-2:2007 does not cover oral appliances.

Schlafapnoe-Atemtherapie - Teil 2: Masken und Anwendungszubehör (ISO 17510-2:2007)

Dieser Teil von ISO 17510 gilt für Masken, ihre Verbindungselemente und für Zubehörteile, die verwendet
werden, um ein Schlafapnoe-Atemtherapiegerät an den Patienten anzuschließen. Er legt Anforderungen an
Masken und Zubehörteile, einschließlich aller Verbindungselemente, fest, die erforderlich sind, um die
Patientenanschlussöffnung des Schlafapnoe-Atemtherapiegeräts mit einem Patienten zu verbinden, und die
bei Anwendung der Schlafapnoe-Atemtherapie eingesetzt werden, z. B. Nasenmasken, Abgasöffnungen und
Kopfgeschirr.
Schlafapnoe-Atemtherapiegeräte werden in ISO 17510-1 behandelt. Siehe auch Bild A.1, in dem die
typischen Bestandteile der beiden Teile von ISO 17510 dargestellt sind.
Dieser Teil von ISO 17510 behandelt keine oralen Vorrichtungen.

Thérapie respiratoire de l'apnée du sommeil - Partie 2: Masques et accessoires d'application (ISO 17510-2:2007)

L'ISO 17510-2:2007 s'applique aux masques, à leur fixation et aux accessoires utilisés pour raccorder l'équipement de thérapie respiratoire de l'apnée du sommeil au patient. Elle spécifie les exigences relatives aux masques et aux accessoires, y compris leurs éléments de raccordement destinés à raccorder l'orifice de raccordement côté patient de l'équipement de thérapie respiratoire de l'apnée du sommeil, et sont utilisés en thérapie respiratoire de l'apnée du sommeil, par exemple le masque nasal, les orifices d'évacuation et le harnais.
L'ISO 17510-2:2007 ne traite pas des prothèses orales.

Zdravljenje dihanja pri prenehanju dihanja v spanju - 2. del: Maske in oprema za nameščanje (ISO 17510-2:2007)

General Information

• Status: Withdrawn
• Publication Date: 10-Mar-2009
• Withdrawal Date: 18-Feb-2020
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation 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
• Completion Date: 19-Feb-2020
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 17510-2:2009 - Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

Relations

• Replaces: EN ISO 17510-2:2007 - Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 17510:2020 - Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)
• Effective Date: 26-Feb-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 17510-2:2008
=GUDYOMHQMHGLKDQMDSULSUHQHKDQMXGLKDQMDYVSDQMXGHO0DVNHLQRSUHPD]D
QDPHãþDQMH,62
Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510
-2:2007)
Schlafapnoe-Atemtherapie - Teil 2: Masken und Anwendungszubehör (ISO 17510-
2:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 2: Masques et accessoires
d'application (ISO 17510-2:2007)
Ta slovenski standard je istoveten z: EN ISO 17510-2:2009
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 17510-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 17510-2:2007
English Version
Sleep apnoea breathing therapy - Part 2: Masks and application
accessories (ISO 17510-2:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 2: Schlafapnoe-Atemtherapie - Teil 2: Masken und
Masques et accessoires d'application (ISO 17510-2:2007) Anwendungszubehör (ISO 17510-2:2007)
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 17510-2:2009: 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 17510-2:2007 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 17510-2:2007.
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 17510-2:2007 has been approved by CEN as a EN ISO 17510-2:2009 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
- 6a This relevant Essential Requirement is
not addressed in this European
Standard
4 13.1, 13.6 a)
4 7.5 (1st paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
4 7.5 (2nd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
4 13.3 (f) This relevant Essential Requirement is
not fully addressed in this European
Standard
4 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
4.1 a) 13.3 (a): This relevant Essential Requirement is
not fully addressed in this European
Standard
4.1 b) 13.3 b)
4.1 c) 9.1, 13.6 b) , 13.6 c)
4.1 d) 9.1, 13.6 b)
4.1 e) 8.6, 13.6 h)
4.1 f) 13.3 i)
4.1 g) 13.3 j)
4.1 h) 13.3 k)
4.1 i) 13.3 b), 13.6 i)
4.1 j) 13.6 k)
4.1 l) 9.1, 13.6 b)
4.1 o) 9.1, 13.6 b)
4.1 m) 13.6 c)
4.1 n) 13.6 n)
4.1 q) 13.6 i)
4.1 r), s) 13.6 d)
4.2 a) 13.2, 13.3 d), 13.5
4.2 b) 13.2, 13.3 e), 13.4
4.2 c) 9.1
4.2 d) 8.7, 13.2, 13.3 c), 13.3 m)
4.2 e) 13.6 g)
5 7.5 (3rd paragraph)
This relevant Essential Requirement is
not fully addressed in this European
Standard
5 4, 7.2, 7.5, 7.6
5.1 12.7.4
5.2 7.1, 7.3
5.3 9.2, 12.8.2
5.4 7.1, 7.3, 8.1, 8.3, 8.4, 8.5
5.5 9.2, 12.8.1, 12.8.2
5.6 8.1
6 12.7.2, 12.7.3
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International standard.

INTERNATIONAL ISO
STANDARD 17510-2
Second edition
2007-10-01
Sleep apnoea breathing therapy —
Part 2:
Masks and application accessories
Thérapie respiratoire de l'apnée du sommeil —
Partie 2: Masques et accessoires d'application

Reference number
ISO 17510-2:2007(E)
©
ISO 2007
ISO 17510-2:2007(E)
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ISO 17510-2:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Information to be supplied by the manufacturer. 3
5 Construction requirements. 4
5.1 Mask connectors. 4
5.2 Biocompatibility. 4
5.3 * Protection against rebreathing . 5
5.4 Cleaning, disinfection and sterilization. 5
5.5 * Breathing during single fault condition . 5
5.6 Breathing system filter. 5
6 Vibration and noise. 6
Annex A (informative) Rationale . 7
Annex B (normative) Exhaust flow test procedure. 11
Annex C (normative) Resistance to flow (pressure drop). 13
Annex D (normative) Anti-asphyxia valve pressure testing . 15
Annex E (normative) Breathing during single fault condition — Determination of the inspiratory
and expiratory resistance . 17
Annex F (normative) CO rebreathing . 19
Annex G (normative) Vibration and noise . 22
Annex H (informative) Guide to information to be supplied by the manufacturer . 23
Annex I (informative) Reference to the essential principles. 24
Annex J (informative) Environmental aspects . 26
Annex K (informative) Terminology — Alphabetized index of defined terms. 27
Bibliography . 29

ISO 17510-2:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has
been established has the right to be represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules
...