ISO 17510-2:2003

INTERNATIONAL ISO
STANDARD 17510-2
First edition
2003-01-15

Sleep apnoea breathing therapy —
Part 2:
Masks and application accessories
Thérapie de l'apnée du sommeil —
Partie 2: Masques et accessoires thérapeutiques




Reference number
ISO 17510-2:2003(E)
©
ISO 2003

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ISO 17510-2:2003(E)
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ii © ISO 2003 – All rights reserved

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ISO 17510-2:2003(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 the European Committee for Standardization (CEN) in collaboration with
Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung
ventilators and related equipment, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
Throughout the text of this document, read ".this European Standard." to mean ".this International
Standard.".
ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing therapy:
— Part 1: Sleep apnoea breathing therapy devices
— Part 2: Masks and application accessories
For the purposes of this part of ISO 17510, the CEN annex regarding fulfilment of European Council
Directives has been removed.
Annex ZZ provides a list of corresponding International and European Standards for which equivalents are not
given in the text.

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ISO 17510-2:2003(E)


Contents
page
Foreword. v
1 Scope .1
2 Normative references .1
3 Terms and definitions.2
4 Information to be supplied by the manufacturer.2
5 Construction requirements.3
5.1 Face mask connectors .3
5.2 Compatibility .3
5.3 Re-breathing.4
6 Methods of test .4
6.1 Test to determine the sound pressure level of the gas exhaust port.4
6.1.1 Principle.4
6.1.2 Apparatus .4
6.1.3 Procedure .4
6.1.4 Expression of results .4
6.2 Test to determine the resistance to flow .5
Annex A (informative) Rationale .7
Annex ZZ (normative) Corresponding International and European Standards for which equivalents are
not given in the text . 9
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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).
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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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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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 autho
...