EN ISO 17510-2:2007

SLOVENSKI STANDARD
01-april-2008
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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 17510-2:2007
ICS:
11.040.10
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 17510-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2007
ICS 11.040.10 Supersedes EN ISO 17510-2:2003
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 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 17510-2:2007: 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 17510-2:2007) 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 17510-2:2003.
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 17510-2:2007 has been approved by CEN as a EN ISO 17510-2:2007 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 confers, 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 Essential requirements (ERs) of EU Qualifying remarks/Notes
this document Directive 93/42/EEC
All 1, 2, 3
4 13.1, 13.6 a)
4.1 a) 13.3 a)
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 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 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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ii © ISO 2007 – All rights reserved

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 given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 17510-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This second edition cancels and replaces the first edition (ISO 17510-2:2003) which has been technically
revised.
ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing therapy :
⎯ Part 1: Sleep apnoea breathing therapy equipment
⎯ Part 2: Masks and application accessories
iv © ISO 2007 – All rights reserved

ISO 17510-2:2007(E)
Introduction
Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep.
The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As a result,
the use of sleep apnoea breathing therapy equipment has become common. This document covers basic
safety and essential performance requirements n
...