SIST EN ISO 17510:2026

SLOVENSKI STANDARD
01-februar-2026
Nadomešča:
SIST EN ISO 17510:2020
Medicinski pripomočki - Zdravljenje dihanja pri spalni apneji - Maske in dodatki za
nameščanje (ISO 17510:2025)
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
(ISO 17510:2025)
Medizinische Geräte - Schlafapnoe-Atemtherapie - Masken und Anwendungszubehör
(ISO 17510:2025)
Dispositifs médicaux - Thérapie respiratoire de l'apnée du sommeil - Masques et
accessoires d'application (ISO 17510:2025)
Ta slovenski standard je istoveten z: EN ISO 17510:2025
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 17510
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2025
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 17510:2020
English Version
Medical devices - Sleep apnoea breathing therapy - Masks
and application accessories (ISO 17510:2025)
Dispositifs médicaux - Thérapie respiratoire de l'apnée Medizinische Geräte - Schlafapnoe-Atemtherapie -
du sommeil - Masques et accessoires d'application (ISO Masken und Anwendungszubehör (ISO 17510:2025)
17510:2025)
This European Standard was approved by CEN on 4 December 2025.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 17510:2025) 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 June 2026, and conflicting national standards shall be
withdrawn at the latest by June 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 17510:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 17510:2025 has been approved by CEN as EN ISO 17510:2025 without any modification.

International
Standard
ISO 17510
Second edition
Medical devices — Sleep apnoea
2025-11
breathing therapy — Masks and
application accessories
Dispositifs médicaux — Thérapie respiratoire de l'apnée du
sommeil — Masques et accessoires d'application
Reference number
ISO 17510:2025(en) © ISO 2025
ISO 17510:2025(en)
© ISO 2025
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 17510:2025(en)
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 . 14
Annex B (normative) Exhaust flow test procedure .18
Annex C (normative) Resistance to flow (pressure drop) .20
Annex D (normative) Anti-asphyxia valve pressure testing .22
Annex E (normative) Determination of the inspiratory and expiratory pressure drop under
single fault condition .24
Annex F (normative) Carbon dioxide rebreathing .26
Annex G (normative) Audible acoustic energy .29
Annex H (informative) Guide to information supplied by the manufacturer .31
Annex I (informative) Reference to the IMDRF essential principles and labelling principles .32
Annex J (informative) Terminology — Alphabetized index of defined terms .34
Bibliography .36

iii
ISO 17510:2025(en)
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 used 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
ISO 17510:2025(en)
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; and
— “can” is used to describe a possibility or capability.

v
International Standard ISO 17510:2025(en)
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]
NOTE This document has been prepared to address the relevant essential principles and labelling principles
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, 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
1) Under preparation. Stage at the time of publication: ISO/DIS 20417:2025.

ISO 17510:2025(en)
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 assessment activities in the
electrotechnical sector
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 20417:— and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE An alphabetical index of defined terms is found in Annex J.
3.1
anti-asphyxia valve
valve used on a breathing mask intended to allow spontaneous breathing when the lung ventilator or
breathing therapy equipment is not providing adequate pressure or flow
[SOURCE: ISO 4135:2022, 3.6.3.7]
3.2
biocompatibility
ability of a medical device, accessory or material to perform with an appropriate host response in a specific
application
Note 1 to entry: A medical device or accessory can produce some level of adverse effect, but that level can be determined
to be acceptable when considering the benefit provided.
[SOURCE: ISO 18562-1:2024, 3.6]
3.3
breathing system filter
BSF
device intended to reduce transmission of particulates, including microorganisms, in a breathing system
[SOURCE: ISO 4135:2022, 3.6.1.5]
3.4
breathing tube
non-rigid tube used to convey gases or vapours within the user-detachable section of a breathing system
[SOURCE: ISO 4135:2022, 3.1.4.4, modified — Deleted Note 1 to entry.]
3.5
cleaning
process to remove contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning of a used product consists of the removal of adherent soil (e.g. blood, protein substances and
other debris) from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated
process that prepares the items for safe handling or further processing.
Note 2 to entry: Cleaning of a new product can occur before initial use or during production before release for
distribution.
ISO 17510:2025(en)
[SOURCE: ISO 17664-2:2021, 3.1, modified — Replaced “removal of” with “process to remove”. In Note 1 to
entry, replaced “and/or” with “or” and added “of a used product”. Added Note 2 to entry.]
3.6
conformity
fulfilment of a requirement
Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word “compliance” is
synonymous but deprecated.
[SOURCE: ISO 9000:2015, 3.6.11, modified — Deleted Note 2 to entry.]
3.7
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 17664-2:2021, 3.5]
3.8
exhaust flow
flow from the mask or application accessory to atmosphere other than the leak due to
improper seal to the face
Note 1 to entry: The exhaust flow can pass through openings in the mask, the connecting element and the mask or
through the anti-asphyxia valve.
Note 2 to entry: The exhaust flow discharges exhaled gases to atmosphere to reduce rebreathing of CO .
[SOURCE: ISO 4135:2022, 3.8.1.3]
3.9
exhaust port
port through which gas is discharged to the atmosphere or to an anaesthetic gas scavenging system
[SOURCE: ISO 4135:2022, 3.1.4.11, modified — Deleted notes to entry.]
3.10
gas output port
port of the device through which gas is delivered at respiratory pressures to a user-detachable part of a
breathing system
[SOURCE: ISO 4135:2022, 3.1.4.22, modified — Deleted Note 1 to entry and deprecated term.]
3.11
gas pathway
interior surfaces over which respiratory gases or liquids pass that can be inspired
EXAMPLE 1 The ventilator breathing system, inlet filter, gas mixer, blower and internal piping.
EXAMPLE 2 Enclosed chamber of an incubator including the mattress or the inner surface of an oxygen hood.
EXAMPLE 3 The inner surfaces of breathing tubes, tracheal tubes or masks and mouthpieces.
Note 1 to entry: The gas pathway is bounded by the fluid ports through which gases or liquids enter the medical device
or accessory. This can include the patient interface or the interior surfaces of enclosures that are in contact with gases
or liquids that can be inspired.
Note 2 to entry: The gas pathway can include some surfaces in the expiratory pathway.
Note 3 to entry: The fluids from a gas pathway can be ingested.
[SOURCE: ISO 18562-1:2024, 3.11, modified — In the definition, added “respiratory”. In Note 1 to entry,
replaced “ports” with “fluid ports”. Replaced Note 3 to entry.]

ISO 17510:2025(en)
3.12
harm
injury or damage to the health of people or animals, or damage to property or the environment
[SOURCE: ISO/IEC Guide 63:2019, 3.1, modified — Added “or animals”.]
3.13
headgear
part that is used to fix the mask to the patient
Note 1 to entry: The headgear may be an integral part of the mask.
3.14
healthcare professional, adj
appropriately trained, knowledgeable and skilled, providing systematic preventive, curative, promotional or
rehabilitative healthcare services
EXAMPLE Healthcare professional user, healthcare professional responsible organization.
[SOURCE: ISO 80601-2-12:2023, 201.3.247, modified — Deleted “to families or communities”. Added
example.]
3.15
intended use
use for which a product or process is intended according to the specifications, instructions for use and other
information supplied by the manufacturer
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with,
user profile, use environment, and operating principle are typical elements of the intended use.
Note 2 to entry: Intended use is different from normal use. Both include the concept of use as intended by the
manufacturer. However, intended use focuses on the medical purpose whereas normal use incorporates not only the
medical purpose, but maintenance, transport, processing, etc. as well.
Note 3 to entry: Product includes service.
[SOURCE: ISO/IEC Guide 63:2019, 3.4, modified — Deleted “or service” and replaced “instructions” with
“instructions for use”, “provided” with “supplied” and added “other”. Added Notes 2 and 3 to entry.]
3.16
inspection
conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing
or gauging
3.17
manufacturer
organization with responsibility for design or manufacture of a medical device or accessory with the intention
of making the medical device or accessory available for use, under its name; whether such a medical device or
accessory is designed or manufactured by that organization itself or on its behalf by another organization
Note 1 to entry: This organization has ultimate legal responsibility for ensuring compliance with all applicable policies
for the medical device or accessory in the countries or jurisdictions where it is intended to be made available or sold,
unless this responsibility is specifically imposed on another organization by the authority having jurisdiction.
Note 2 to entry: The manufacturer’s responsibilities include meeting both pre-market requirements and post-market
requirements, such as adverse event reporting and notification of corrective actions.
Note 3 to entry: “Design or manufacture” can include specification development, production, fabrication, assembly,
processing, packaging, repackaging, labelling, relabelling, sterilization, installation or remanufacturing of a medical
device or accessory; or putting a collection of medical devices or accessories, and possibly other products, together for a
medical purpose.
ISO 17510:2025(en)
Note 4 to entry: Any organization which assembles or adapts a medical device or accessory that has already been
supplied by another organization for an individual patient, in accordance with the instructions for use, is not the
manufacturer, provided the assembly or adaptation does not change the intended use of the medical device or accessory.
Note 5 to entry: Any organization which changes the intended use of or modifies a medical device or accessory without
acting on behalf of the original manufacturer and which makes it available for use under its own name, is considered
the manufacturer of the modified medical device or accessory.
Note 6 to entry: An authorized representative, distributor or importer who only adds their own address and contact
details to the medical device, accessory or the packaging, without covering or changing the existing information supplied
by the manufacturer, is not considered a manufacturer.
Note 7 to entry: To the extent that an accessory is subject to the applicable policies of a medical device, the organization
responsible for the design or manufacture of that accessory is considered to be a manufacturer.
[SOURCE: ISO/IEC Guide 63:2019, 3.6, modified — Added “or accessory”, replaced “whether or not” with
“whether”, “and/or” with “or”, “natural or legal person” and “person” with “organization”, “regulatory
requirements” with “applicable policies”, “Regulatory Authority within that jurisdiction” with “authority
having jurisdiction”, inserted “IMDRF” and replaced “labelling” with “information supplied by the
manufacturer”.]
3.18
mask
device which provides a non-invasive interface between the patient’s airway and a patient-connection port or
other connection to a source of respirable gas
[SOURCE: ISO 4135:2022, 3.8.6.4]
3.19
ME equipment
medical electrical equipment
electrical medical device having an applied part or transferring energy or substances to or from the patient
or detecting such energy or substance transfer to or from the patient
Note 1 to entry: If ME equipment is provided with more than one connection to a particular mains, then the combination
of the ME equipment and its mains connections is a medical electrical system.
Note 2 to entry: The ME equipment includes those accessories and detachable parts as defined by the manufacturer.
Note 3 to entry: Not all electrical equipment used in medical practice falls within this definition.
Note 4 to entry: The definition of medical device is broader than that of ME equipment.
Note 5 to entry: The transfer or detecting of energy includes optical radiation, ionising radiation, ultrasound and
magnetic resonance.
[SOURCE: IEC 60601-1:2005, 3.63, modified — Replaced “electrical equipment” with “electrical medical
device” and “supply mains” with “mains”, added “or substances”, deleted item b), deleted “and which is
provided with not more than one connection to a particular mains”. Added Notes 1, 2, 4 and 5 to entry.]
3.20
normal condition
condition of a product in which all risk control measures are intact
[SOURCE: IEC 60601-1:2005, 3.70, modified — Added “of a product” and replaced “means provided for
protection against hazards” with “risk control measures”.]
3.21
oral appliance
device intended to maintain the oral airway by mechanical means and which achieves its purpose
independently of sleep apnoea breathing therapy equipment

ISO 17510:2025(en)
3.22
patient-connection port
port of a breathing system intended for connection to an airway device
Note 1 to entry: The patient-connection port is the end of the breathing system proximal to the patient.
Note 2 to entry: The patient-connection port is typically a connector suitable for connection to an airway device such
as a tracheal tube, tracheostomy tube, face mask or supralaryngeal airway.
Note 3 to entry: Current product standards typically specify that the patient-connection port is required to be in the
form of specific standardized connectors, for example, a connector conforming to ISO 5356-1.
Note 4 to entry: In anaesthetic and respiratory equipment where its function is dependent upon a design feature of
the component that connects the equipment to the patient’s airway, then there is no patient-connection-port. Examples
include non-invasive ventilation using a face mask with an integrated expiratory port, or oxygen therapy using an
open mask.
[SOURCE: ISO 4135:2022, 3.1.4.41]
3.23
procedure
specified way to carry out an activity or a process
Note 1 to entry: Procedures can be documented or not.
[SOURCE: ISO 9000:2015, 3.4.5]
3.24
process
set of interrelated or interacting activities that use inputs to deliver an intended result
Note 1 to entry: Whether the “intended result” of a process is called output, product or service depends on the context
of the reference.
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally
the inputs to other processes.
Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.
[SOURCE: ISO 9000:2015, 3.4.1, modified — Deleted Notes 4, 5 and 6 to entry.]
3.25
rated
assigned by the manufacturer for a specified operating condition
Note 1 to entry: A rated value can have a tolerance.
[SOURCE: IEC 60601-1:2005, 3.97, modified — Deleted “term referring to a value”.]
3.26
rebreathing
inhalation of expired gas mixture from which carbon dioxide may or may not have been removed
[SOURCE: ISO 4135:2022, 3.1.5.12]
3.27
risk
combination of the probability of occurrence of harm and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation and the possibility to
avoid or limit the harm.
Note 2 to entry: In French, the term “risqué” also denotes the potential source of harm, in English “hazard”.
[SOURCE: IEC 60050-903:2013, 903-01-07, modified — Added Note 1 to entry.]

ISO 17510:2025(en)
3.28
risk management
systematic application of management policies, procedures and practices to the tasks of analysing, evaluating,
controlling and monitoring risk
[SOURCE: ISO/IEC Guide 63:2019, 3.15]
3.29
risk management file
set of records and other documents that are produced by risk management
[SOURCE: ISO 14971:2019, 3.25]
3.30
single fault condition
condition of a product in which a single risk control measure is defective
Note 1 to entry: If a single fault condition causes one or more other fault conditions, all shall be considered as one single
fault condition.
Note 2 to entry: Failure of a component designed to maintain basic safety or essential performance shall be considered
a single fault condition.
Note 3 to entry: An abnormal external situation is not a single fault condition.
[SOURCE: IEC 60601-1:2005, 3.116, and IEC 60601-1:2005/AMD1:2012, 3.116, modified — Replaced
“ME equipment” with “a medical device or accessory” and “means for reducing a risk” with “risk control
measure”, deleted “or a single abnormal condition is present”. Replaced the note with Note 1 to entry. Added
Note 2 to entry.]
3.31
sleep apnoea breathing therapy equipment
ME equipment delivering a therapeutic breathing pressure to the patient intended to treat obstructive sleep
apnoea by keeping the upper airways open
Note 1 to entry: Sleep apnoea breathing therapy equipment is primarily used in the home healthcare environment by a
lay user without direct professional supervision.
[SOURCE: ISO 80601-2-70:—, 201.3.257]
3.32
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use
or application have been fulfilled
Note 1 to entry: Validation involves a set of activities for gaining confidence that a system is able to accomplish its
intended use, goals and objectives in its operational environment. In short, validation gives the confidence that the
correct system was built to fulfil what is required for its intended application.
Note 2 to entry: The use conditions for validation can be real or simulated.
Note 3 to entry: The word “validated” is used to designate the corresponding status.
Note 4 to entry: In design and development, validation concerns the process of examining an item to determine
conformity with user needs.
Note 5 to entry: Validation is normally performed during the final stage of development, under defined operating
conditions, although it may also be performed in earlier stages.
Note 6 to entry: Multiple validations may be carried out if there are different intended uses.
[SOURCE: IEC 60050-192:2024, 192-01-18, modified — Added Notes 3, 4, 5 and 6 to entry.]

ISO 17510:2025(en)
4 Information supplied by the manufacturer
4.1 General
a) Masks, headgear and their accessories shall be provided with accompanying information.
b) The accompanying information shall be regarded as a part of masks, headgear and their accessories.
c) The information supplied by the manufacturer of masks, headgear and their accessories shall conform to
ISO 20417:—.
NOTE 1 The purpose of an accompanying information is to promote the safe use of a mask, headgear or their
accessories during the expected lifetime.
NOTE 2 Annex H contains guidance to help in locating the information supplied by the manufacturer
requirements contained in other clauses of this document.
d) Check conformity by inspection of the information supplied by the manufacturer.
4.2 Accompanying information
a) The accompanying information of the mask, headgear, or other accessory shall contain the following
information:
1) if the packaging contains more than one component, information necessary for correct assembly of
the components;
2) if the mask or accessory includes an exhaust port, a warning statement to the effect that: “WARNING:
Occlusion of the exhaust needs to be prevented to avoid having an adverse effect on the safety and
quality of the therapy”;
3) a statement to the effect that combination with other medical devices not intended to be combined
with the mask can decrease the safety or alter the performance of the mask (e.g. in combination
with a humidifier for medical use, nebulizer, heat and moisture exchanger (HME), filters, bi-level
positive airway pressure equipment, self-adjusting equipment, or additional oxygen supply or any
exhaust port);
4) if applicable, information about the means provided to minimize rebreathing (see 5.3);
5) the rated pressure range of the mask including any connecting element;
6) if specified for reuse, a warning statement to the effect that: “WARNING: frequency of cleaning,
methods of cleaning or the use of cleaning agents, other than those specified in the instructions for
use, or exceeding the number of processing cycles can have an adverse effect on the [place name of
component here] and consequently the safety or the quality of the therapy”;
7) information for the user to identify parameters or criteria that can indicate a safety or efficacy
change in the mask or accessory (e.g. visual inspection criteria); as well as the course of action to
follow because of this identification (e.g. disposal or component replacement procedure);
8) the shelf life of masks and their accessories;
9) the expected lifetime of masks and their accessories;
10) the pressure drop, between the patient airway interface of the mask and the patient-connection port
at flowrates of 50 l/min and 100 l/min, as determined in Annex C;
NOTE 1 There is guidance or rationale for this list element contained in Clause A.2.
11) for masks that cover the nose and the mouth, the inspiratory, and expiratory pressure drop of the
mask in combination with the anti-asphyxia valve open to atmosphere, as determined in Annex E;
NOTE 2 There is guidance or rationale for this list element contained in Clause A.3.

ISO 17510:2025(en)
12) the pressure-flow curve of the exhaust flow throughout the working pressure range as determined
in Annex B;
NOTE 3 There is guidance or rationale for this list element contained in Clause A.4.
13) for headgear and masks with magnets, the maximum magnetic flux density at the worst-case
location of normal use, both when:
i) patient worn; and
ii) disengaged as for removal from a patient:
I) magnet flux density should be measured and expressed in millitesla (mT).
II) IEC 60404-5 may be used to determine the magnetic flux density.
14) for headgear and masks with magnets, a warning statement to the effect that: “WARNING: keep
the headgear and their magnets away from devices and implants that can be affected by magnetic
fields”:
i) Safety sign ISO 7010–W006 may be used.
15) for headgear and masks with magnets, a disclosure to the effect that use of the mask is
contraindicated for patients and their household members, caregivers, and bed partners that are in
close vicinity to patients using the mask, and that have implanted devices with metallic components
that are susceptible to magnetic fields, which can include the following:
— pacemakers;
— implantable cardioverter defibrillators (ICD);
— neurostimulators;
— magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e. neck
and head);
— CSF (cerebral spinal fluid) shunts [e.g. VP (ventriculo peritoneal) shunt];
— aneurysm clips;
— embolic coils;
— intracranial aneurysm intravascular flow disruption devices;
— metallic splinters in the eye;
— ocular implants (e.g. glaucoma implants, retinal implants);
— implants to restore hearing or balance that have an implanted magnet (such as cochlear implants,
implanted bone conduction hearing devices, and auditory brainstem implants)
— metallic stents (e.g. aneurysm, coronary, tracheobronchial, biliary);
— implantable ports and pumps (e.g. insulin pumps);
— hypoglossal nerve stimulators.
b) Check conformity by inspection of the accompanying information.

ISO 17510:2025(en)
5 Construction requirements
5.1 Mask connectors
a) Mask connectors, if conical, shall be 15 mm or 22 mm size cone connectors conforming to ISO 5356-1:2015
or ISO 5356-2:2012 and ISO 5356-2:2012/Amd 1:2019.
b) Non-conical mask connectors s
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