ISO/FDIS 17510

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.

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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
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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
...