SIST EN ISO 17510-2:2003

SLOVENSKI STANDARD
SIST EN ISO 17510-2:2003
01-september-2003
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Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510
-2:2003)
Schlafapnoe-Atemtherapie - Teil 2: Masken und Anwendungszubehör (ISO 17510-
2:2003)
Thérapie respiratoire de l'apnée du sommeil - Partie 2: Masques et accessoires
thérapeutiques (ISO 17510-2:2003)
Ta slovenski standard je istoveten z: EN ISO 17510-2:2003
ICS:
11.040.10
SIST EN ISO 17510-2:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 17510-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2003
ICS 11.040.10
English version
Sleep apnoea breathing therapy - Part 2: Masks and application
accessories (ISO 17510-2:2003)
Thérapie de l'apnée du sommeil - Partie 2: Masques et Schlafapnoe-Atemtherapie - Teil 2: Masken und
accessoires thérapeutiques (ISO 17510-2:2003) Anwendungszubehör (ISO 17510-2:2003)
This European Standard was approved by CEN on 9 September 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510-2:2003 E
worldwide for CEN national Members.

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EN ISO 17510-2:2003 (E)
Contents
page
Foreword.3
1 Scope .4
2 Normative references .4
3 Terms and definitions.5
4 Information to be supplied by the manufacturer.5
5 Construction requirements.6
5.1 Face mask connectors .6
5.2 Compatibility .6
5.3 Re-breathing.7
6 Methods of test .7
6.1 Test to determine the sound pressure level of the gas exhaust port.7
6.1.1 Principle.7
6.1.2 Apparatus .7
6.1.3 Procedure .7
6.1.4 Expression of results .7
6.2 Test to determine the resistance to flow .8
Annex A (informative) Rationale .10
Annex ZA (informative) Clauses of this European Standard addressing Essential Requirements or
other provisions of EU Directives .12
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EN ISO 17510-2:2003 (E)
Foreword
This document (EN ISO 17510-2:2003) has been prepared by Technical Committee CEN /TC 215, "Respiratory
and anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with ISO/TC 121 "Anaesthetic
and respiratory equipment".
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 July 2003, and conflicting national standards shall be withdrawn at the latest by
July 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 EU Directive(s).
For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.
EN ISO 17510 covers sleep apnoea breathing therapy products for patients to use in the home. Part 1 applies to
the sleep apnoea breathing therapy devices. This part 2 applies to masks, their fixing and to the accessories used
to connect a sleep apnoea breathing therapy device to the patient.
Annex A is informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
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EN ISO 17510-2:2003 (E)
1 Scope
This part of the European Standard specifies requirements for masks and accessories which are required to
connect the patient connection port to a sleep apnoea breathing therapy device and the mask to a patient, and are
used for the application of sleep apnoea breathing therapy e.g. nasal masks, gas exhaust ports, connecting
element and headgear.
This part of EN ISO 17510 does not cover oral appliances.
NOTE 1 Sleep apnoea breathing therapy devices are covered by EN ISO 17510-1 (see Figure A.1 for typical elements of the
two parts of EN ISO 17510).
NOTE 2 Annex A contains rationale statements for this Part of EN ISO 17510.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1281-1, Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets.
EN 1281-2, Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing
connectors (ISO 5356-2:1987 modified)
EN ISO 3744 Acoustics — Determination of sound power levels of noise sources using sound pressure —
Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994).
EN ISO 4135:2001, Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001).
EN ISO 10993 series, Biological evaluation of medical devices.
EN ISO 14971, Medical devices - Application of risk management to medical devices (ISO 14971:2000).
EN ISO 17510-1:2002, Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO
17510-1:2002).
EN 60651, Sound level meters (IEC 60651:1993)
EN 60804, Integrating-averaging sound level meters (IEC 60804:2000)
IEC/TR 60959, Provisional head and torso simulator for acoustic measurements on air conduction hearing aids.
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EN ISO 17510-2:2003 (E)
3 Terms and definitions
For the purposes of this part of the European Standard, the terms and definitions given in EN ISO 4135:2001,
EN ISO 17510-1:2002 and the following apply.
3.1
oral appliance
device intended to maintain the oral airway by mechanical means which achieves its purpose independently of a
sleep apnoea breathing therapy device
3.2
headgear
part that is used to fix the mask in the appropriate position on the patient
3.3
mask
part which provides the interface between the patient and the patient connection port or the connecting element
NOTE 1 According to their application, masks are divided into nasal masks, oral masks or nasal-oral masks.
NOTE 2 A mask can additionally include specific facilities, e.g. supplementary gas connector, gas exhaust port, monitoring
connector, means to minimize re-breathing.
3.4
connecting element
part connecting the patient connection port and the mask
NOTE A connecting element can include specific facilities, e.g. supplementary gas connector, gas exhaust port, monitoring
connector, means to minimize re-breathing.
4 Information to be supplied by the manufacturer
The label of the packaging and/or the instructions for use shall contain the following information:
4.1 if imported into the EU, the name and address of the person responsible or the authorized representative of
the manufacturer or the importer established within the EU;
4.2 the intended purpose of the mask and application accessories;
4.3 the pressure-flow curve of any gas exhaust port throughout the working pressure range (see A.3);
4.4 the working pressure range of the mask and/or the connecting element;
4.5 the sound pressure level of any gas exhaust port measured according to 6.1 (see A.4);
4.6 if appropriate, the symbol STERILE in accordance with EN 980 and the method of sterilization;
4.7 if appropriate, the symbol LOT in accordance with EN 980 or serial number;
4.8 if appropriate, an indication of the date by which the mask and application accessories can be used safely,
expressed as the year and month;
4.9 if appropriate, an indication that the mask and application accessories are not for re-use;
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EN ISO 17510-2:2003 (E)
4.10 if re-usable:
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...