ISO/FDIS 17510

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

ISO 17510:2015 applies to masks and their 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 for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

Dispositifs médicaux — Thérapie respiratoire de l'apnée du sommeil — Masques et accessoires d'application

L'ISO 17510:2015 s'applique aux masques et à leurs accessoires utilisés pour raccorder un matériel de traitement respiratoire de l'apnee du sommeil au patient. Elle spécifie les exigences relatives aux masques et aux accessoires, y compris tout élément de raccordement, nécessaires pour raccorder l'orifice de raccordement cote patient du materiel de traitement respiratoire de l'apnee du sommeil à un patient pour le traitement respiratoire de l'apnée du sommeil (par exemple, le masque nasal, les orifices d'évacuation et le harnais).

General Information

• Status: Not Published
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
• Drafting Committee: ISO/TC 121/SC 3/JWG 12 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Home respiratory equipment
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 08-Sep-2025
• Completion Date: 08-Sep-2025

Relations

• Consolidates: ISO 17842-2:2022 - Safety of amusement rides and amusement devices — Part 2: Operation and use
• Effective Date: 24-Feb-2024

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/TC 121/SC 3
Medical devices — Sleep apnoea
Secretariat: ANSI
breathing therapy — Masks and
Voting begins on:
application accessories
2025-09-08
Dispositifs médicaux — Thérapie respiratoire de l'apnée du
Voting terminates on:
sommeil — Masques et accessoires d'application
2025-11-03
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 121/SC 3
Medical devices — Sleep apnoea
Secretariat: ANSI
breathing therapy — Masks and
Voting begins on:
application accessories
Dispositifs médicaux — Thérapie respiratoire de l'apnée du
Voting terminates on:
sommeil — Masques et accessoires d'application
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
This draft is submitted to a parallel vote in ISO and in IEC.
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Information supplied by the manufacturer . 8
4.1 General .8
4.2 Accompanying information .8
5 Construction requirements . 10
5.1 Mask connectors .10
5.2 Biocompatibility .10
5.2.1 Patient contacting .10
5.2.2 Gas pathway contacting .10
5.3 Protection against rebreathing .10
5.3.1 Normal condition protection .11
5.3.2 Single fault condition protection .11
5.4 Cleaning, disinfection, and sterilization .11
5.4.1 Single patient multiple use .11
5.4.2 Multiple patient multiple use . 12
5.5 Breathing during single fault condition . 12
5.6 Breathing system filter . 13
6 Audible acoustic energy .13
7 Measurement uncertainty .13
Annex A (informative) Particular guidance and rationale .15
Annex B (normative) Exhaust flow test procedure . 19
Annex C (normative) Resistance to flow (pressure drop) .21
Annex D (normative) Anti-asphyxia valve pressure testing .23
Annex E (normative) Determination of the inspiratory and expiratory pressure drop under
single fault condition .25
Annex F (normative) Carbon dioxide rebreathing .27
Annex G (normative) Audible acoustic energy .30
Annex H (informative) Guide to information supplied by the manufacturer .32
Annex I (informative) Reference to the IMDRF essential principles and labelling principles .33
Annex J (informative) Terminology — Alphabetized index of defined terms .35
Bibliography .37

iii
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment for patient care, and Technical
Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular medical
equipment, software, and systems, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 17510:2015), which has been technically
revised.
The main changes are as follows:
— harmonization with IEC 60050-880 sources, where appropriate;
— adding disclosure requirements for magnets in headgear;
— updated processing requirements;
— updated noise requirements;
— referencing ISO 18562-1, for biocompatibility of gas pathways;
— harmonization with ISO 20417, where appropriate.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
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 for masks and other application accessories needed to protect
patients during use of this equipment.
Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the typical
elements of this document together with the sleep apnoea breathing therapy equipment of ISO 80601-2-70
that form a sleep apnoea breathing system.
In this document, the following print types are used:
— Requirements and definitions: roman type.
— Informative material appearing outside of tables, such as notes, examples, and references: in smaller
type. Normative text of tables is also in a smaller type.
— Terms defined in Clause 3 in this document or as noted: italics.
In referring to the structure of this document, the term:
— “clause” means one of the numbered divisions within the table of contents, inclusive of all subdivisions
(e.g. Clause 5 includes 5.1, 5.2, etc.);
— “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2, and 5.3.1 are all subclauses of
Clause 5).
References to clauses within this document are preceded by the term “Clause” followed by the clause number.
References to subclauses within this particular document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
...

TC /SC /
ISO/TC 121/SC 3
Date: 2025-06-09
Draft
TC /SC /JWG Secretariat: ANSI
Date: 2025-08-22
Medical devices — Sleep apnoea breathing therapy — Masks and
application accessories
Dispositifs médicaux — Thérapie respiratoire de l'apnée du sommeil — Masques et accessoires d'application
FDIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights
of which they are aware and to provide supporting documentation.

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Information supplied by the manufacturer . 8
4.1 General . 8
4.2 Accompanying information . 9
5 Construction requirements . 11
5.1 Mask connectors . 11
5.2 Biocompatibility . 11
5.3 Protection against rebreathing . 12
5.4 Cleaning, disinfection, and sterilization . 12
5.5 Breathing during single fault condition . 14
5.6 Breathing system filter . 14
6 Audible acoustic energy . 14
7 Measurement uncertainty . 15
Annex A (informative) Particular guidance and rationale . 16
Annex B (normative) Exhaust flow test procedure . 20
Annex C (normative) Resistance to flow (pressure drop) . 22
Annex D (normative) Anti-asphyxia valve pressure testing . 24
Annex E (normative) Determination of the inspiratory and expiratory pressure drop under
single fault condition . 26
Annex F (normative) Carbon dioxide rebreathing . 28
Annex G (normative) Audible acoustic energy . 32
Annex H (informative) Guide to information supplied by the manufacturer . 34
Annex I (informative) Reference to the IMDRF essential principles and labelling principles . 35
Annex J (informative) Terminology — Alphabetized index of defined terms . 37
Bibliography . 39

iii
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment for patient care, and Technical
Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular medical
equipment, software, and systems., in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition of (ISO 17510:2015), which has been technically
revised.
The main changes are as follows:
— harmonization with IEC 60050-880 sources, where appropriate;
— adding disclosure requirements for magnets in headgear;
— updated processing requirements;
— updated noise requirements;
— referencing ISO 18562-1, for biocompatibility of gas pathways; and
— harmonization with ISO 20417, where appropriate.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
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 for masks and other application accessories needed to protect
patients during use of this equipment.
Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the typical
elements of this document together with the sleep apnoea breathing therapy equipment of ISO 80601-2-70 that
form a sleep apnoea breathing system.
In this document, the following print types are used:
— requirementsRequirements and definitions: roman type;.
— informativeInformative material appearing outside of tables, such as notes, examples, and references: in
smaller type. Normative text of tables is also in a smaller type;.
— Terms defined in Clause 3 in this document or as noted: italics.
In referring to the structure of this document, the term:
— “clause” means one of the numbered divisions within the table of contents, inclusive of all subdivisions
(e.g. Clause 5 includes 5.1, 5.2, etc.), and.);
— “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2, and 5.3.1 are all subclauses of
Clause 5).
References to clauses within this document are preceded by the term “Clause” followed by the clause number.
References to subclauses within this particular document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission; and
— "“can"” is used to describe a possibility or capability.
v
Medical devices — Sleep apnoea breathing therapy — Masks and
application accessories
1 Scope
This document 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 for
the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy
equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
[14[15]] [16]
NOTE This document has been prepared to address the relevant essential principles and labelling
[15 ]
principles guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2:2012+AMD1:2018, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-
threaded weight-bearing connectors
ISO 5356-2:2012/Amd 1:2019, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-
threaded weight-bearing connectors — Amendment 1
ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process

1)
ISO 20417:— , Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to
assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC Guide 115:2023, Application of uncertainty of measurement to conformity
...

PROJET FINAL
Norme
internationale
ISO/TC 121/SC 3
Dispositifs médicaux — Thérapie
Secrétariat: ANSI
respiratoire de l'apnée du
Début de vote:
sommeil — Masques et accessoires
2025-09-08
d'application
Vote clos le:
2025-11-03
Medical devices — Sleep apnoea breathing therapy — Masks and
application accessories
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
Ce projet est soumis à un vote parallèle à ISO et à IEC.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
PROJET FINAL
Norme
internationale
ISO/TC 121/SC 3
Dispositifs médicaux — Thérapie
Secrétariat: ANSI
respiratoire de l'apnée du
Début de vote:
sommeil — Masques et accessoires
2025-09-08
d'application
Vote clos le:
2025-11-03
Medical devices — Sleep apnoea breathing therapy — Masks and
application accessories
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
Ce projet est soumis à un vote parallèle à ISO et à IEC.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2025 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse Numéro de référence
ii
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d'application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Informations fournies par le fabricant . 8
4.1 Généralités .8
4.2 Informations d'accompagnement .9
5 Exigences relatives à la construction . 10
5.1 Raccords de masque .10
5.2 Biocompatibilité .11
5.2.1 Contact avec le patient .11
5.2.2 Contact avec le chemin de gaz .11
5.3 Protection contre la réinspiration .11
5.3.1 Protection en condition normale .11
5.3.2 Protection en condition de premier défaut . 12
5.4 Nettoyage, désinfection et stérilisation . 12
5.4.1 Réutilisable par un seul patient . 12
5.4.2 Réutilisable par plusieurs patients . 13
5.5 Respiration en condition de premier défaut . 13
5.6 Filtre pour système respiratoire .14
6 Énergie acoustique audible . 14
7 Incertitude de mesure. 14
Annexe A (informative) Préconisations particulières et exposé des motifs .16
Annexe B (normative) Mode opératoire de l'essai de débit d'évacuation .20
Annexe C (normative) Résistance au débit (chute de pression) .22
Annexe D (normative) Essais de mesure de la pression de la valve anti-asphyxie .24
Annexe E (normative) Détermination de la résistance inspiratoire et expiratoire en condition
de premier défaut .26
Annexe F (normative) Réinspiration de dioxyde de carbone .28
Annexe G (normative) Énergie acoustique audible .31
Annexe H (informative) Guide relatif aux informations fournies par le fabricant .33
Annexe I (informative) Référence aux principes essentiels et aux principes d'étiquetage de
l'IMDRF .34
Annexe J (informative) Terminologie — Index alphabétique des termes définis .36
Bibliographie .38

iii
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux
de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général
confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité
de tout droit de propriété revendiqué à cet égard. À la date de publication du présent document, l'ISO
n'avait pas reçu notification qu'un ou plusieurs brevets pouvaient être nécessaires à sa mise en application.
Toutefois, il y a lieu d'avertir les responsables de la mise en application du présent document que des
informations plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à
l'adresse www.iso.org/brevets. L'ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou
partie de tels droits de brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l'intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion de
l'ISO aux principes de l'Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir www.iso.org/avant-propos.
Le présent document a été élaboré conjointement par le comité technique ISO/TC 121, Matériel d'anesthésie
et de réanimation respiratoire, sous-comité SC 3, Appareils respiratoires et équipements connexes utilisés
pour les soins aux patients, et le comité technique IEC/TC 62, Appareils, logiciels et systèmes médicaux,
sous-comité SC D, Appareils, logiciels et systèmes médicaux particuliers, en collaboration avec le comité
technique CEN/TC 215 du Comité européen de normalisation (CEN), Équipement respiratoire et anesthésique,
conformément à l'Accord de coopération technique entre l'ISO et le CEN (Accord de Vienne).
Cette deuxième édition annule et remplace la première édition (ISO 17510:2015), qui a fait l’objet d’une
révision technique.
Les principales modifications sont les suivantes:
— harmonisation avec les sources de l'IEC 60050-880, le cas échéant;
— ajout d'exigences de divulgation pour les aimants dans les harnais;
— mise à jour des exigences en matière de traitement;
— mise à jour des exigences relatives au bruit;
— référence à l'ISO 18562-1, pour la biocompatibilité des circuits de gaz respiratoire;
— harmonisation avec l'ISO 20417, le cas échéant.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l’adresse www.iso.org/fr/members.html.

iv
Introduction
L'apnée du sommeil correspond à des arrêts répétés, cliniquement importants, de la respiration normale
au cours du sommeil. La sensibilisation aux risques associés à l'apnée du sommeil s'est considérablement
développée ces dernières années. Par conséquent, l'usage de l'équipement de thérapie respiratoire pour
l'apnée du sommeil est devenu courant. Le présent document couvre les exigences fondamentales en matière
de sécurité et les exigences essentielles en matière de performance applicables aux masques et autres
accessoires nécessaires pour protéger les patients lors de l'utilisation de ce type de matériel.
L'équipement de thérapie respiratoire pour l'apnée du sommeil est traité dans l'ISO 80601-2-70. La Figure A.1
représente les éléments types du présent document conjointement avec l'équipement de thérapie respiratoire
pour l'apnée du sommeil de l'ISO 80601-2-70 qui forment un système respiratoire de traitement de l'apnée du
sommeil.
Dans le présent document, les polices et caractères suivants sont employés:
— exigences et définitions: cambria;
...