EN ISO 17510:2020

SLOVENSKI STANDARD
01-april-2020
Nadomešča:
SIST EN ISO 17510-2:2009
Medicinski pripomočki - Zdravljenje dihanja pri spalni apneji - Maske in oprema za
nameščanje (ISO 17510:2015)
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
(ISO 17510:2015)
Medizinische Geräte - Schlafapnoe-Atemtherapie - Masken und Anwendungszubehör
(ISO 17510:2015)
Dispositifs médicaux - Thérapie respiratoire de l'apnée du sommeil - Masques et
accessoires d'application (ISO 17510:2015)
Ta slovenski standard je istoveten z: EN ISO 17510:2020
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
February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical devices - Sleep apnoea breathing therapy - Masks
and application accessories (ISO 17510:2015)
Dispositifs médicaux - Thérapie respiratoire de l'apnée Medizinische Geräte - Schlafapnoe-Atemtherapie -
du sommeil - Masques et accessoires d'application (ISO Masken und Anwendungszubehör (ISO 17510:2015)
17510:2015)
This European Standard was approved by CEN on 11 November 2019.

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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 17510:2015 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 17510:2020 by 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 August 2020, and conflicting national standards shall
be withdrawn at the latest by August 2020.
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 17510-2:2009.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 17510:2015 has been approved by CEN as EN ISO 17510:2020 without any modification.

INTERNATIONAL ISO
STANDARD 17510
First edition
2015-08-01
Medical devices — Sleep apnoea
breathing therapy — Masks and
application accessories
Dispositifs médicaux — Thérapie respiratoire de l’apnée du sommeil
— Masques et accessoires d’application
Reference number
ISO 17510:2015(E)
©
ISO 2015
ISO 17510:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

ISO 17510:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Information to be supplied by the manufacturer . 3
4.1 General . 3
4.2 Marking on the protective packaging . 3
4.3 A ccompanying document . 4
5 Construction requirements . 5
5.1 Ma sk connectors . 5
5.2 Biocompatibility . 5
5.3 Protection against rebreathing . 6
5.3.1 Normal condition protection . 6
5.3.2 Single fault condition protection . 6
5.4 Cleaning, disinfection, and sterilization . 6
5.5 Breathing during single fault condition . 7
5.6 Breathing system filter . 7
6 Vibration and noise . 7
Annex A (informative) Particular guidance and rationale . 8
Annex B (normative) Exhaust flow test procedure .12
Annex C (normative) Resistance to flow (pressure drop) .14
Annex D (normative) Anti-asphyxia valve pressure testing .16
Annex E (normative) Determination of the inspiratory and expiratory resistance under
single fault condition .18
Annex F (normative) Carbon Dioxide rebreathing .20
Annex G (normative) Vibration and noise .23
Annex H (informative) Guide to information to be supplied by the manufacturer .25
Annex I (informative) Reference to the essential principles .26
Annex J (informative) Terminology — alphabetized index of defined terms .28
Bibliography .30
ISO 17510:2015(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.
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 documents 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).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This first edition cancels and replaces the second edition of ISO 17510-2:2007 which has been technically
revised with the following changes:
— removing the single fault condition testing for rebreathing for nasal-only masks as patients
can breathe through their mouth in that circumstance;
— referencing ISO 80601-2-70 for sleep apnoea therapy equipment.
NOTE ISO 17510-1 was replaced by ISO 80601-2-70.
iv © ISO 2015 – All rights reserved

ISO 17510:2015(E)
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
International Standard covers basic safety and essential performance requirements for masks and
other application accessories needed to protect patients during use of this equipment.
In this International Standard, the following print types are used:
— requirements and definitions: roman type;
— test specifications: italic 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 International Standard or as noted: small capitals type.
In referring to the structure of this International Standard, 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 International Standard are preceded by the term “Clause” followed
by the clause number. References to subclauses within this particular International Standard are by
number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if
any combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in ISO/IEC Directives
Part 2, Annex H. For the purposes of this International Standard, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
International Standard;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this International Standard;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised
ISO publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the
content of this publication not be adopted for mandatory implementation nationally earlier than three
years from the date of publication for equipment newly designed and not earlier than five years from
the date of publication for equipment already in production.
INTERNATIONAL STANDARD ISO 17510:2015(E)
Medical devices — Sleep apnoea breathing therapy —
Masks and application accessories
1 Scope
This International Standard applies to masks and their accessories used to connect 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).
Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the
typical elements of this International Standard together with the sleep apnoea breathing therapy
equipment of ISO 80601-2-70 that form a sleep apnoea breathing system.
This International Standard does not cover oral appliances.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
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 10993-1:2009, 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 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
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
ISO 17510:2015(E)
ISO 80601-2-70:2015, Medical Electrical Equipment — Part 2-70: Particular requirements for basic safety
and essential performance of sleep apnoea breathing therapy equipment
IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135:2001, ISO 17664:2004,
ISO 23328-2:2002, ISO 80601-2-70:2015, IEC 60601-1:2005+A1:2012 and the following apply.
NOTE An alphabetical index of defined terms is found in Annex J.
3.1
anti-asphyxia valve
valve used on a mask, which covers the mouth and is opened to atmosphere when the sleep apnoea
breathing therapy equipment is not providing adequate pressure at the mask, and that is closed to
atmosphere when the sleep apnoea breathing therapy equipment is providing adequate pressure
at the mask
3.2
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 .
3.3
expected useful life
time period specified by the manufacturer during which the medical device or accessory is expected
to remain suitable for use under the conditions specified by the manufacturer
Note 1 to entry: Cleaning and other processing can be necessary during the expected useful life.
3.4
headgear
part that is used to fix the mask to the patient
3.5
mask
part which provides the interface between the patient and the patient-connection port
Note 1 to entry: According to their application, masks are divided into nasal masks, oral masks, or nasal-oral
masks.
3.6
multi-patient reuse
capable of being re-used multiple times on multiple patients
3.7
oral appliance
device intended to maintain the oral airway by mechanical means and which achieves its purpose
independently of sleep apnoea breathing therapy equipment
2 © ISO 2015 – All rights reserved

ISO 17510:2015(E)
3.8
single fault condition
condition of me equipment or accessory in which a single means for reducing a risk is defective or a
single abnormal condition is present
[SOURCE: IEC 60601-1:2005+A1:2012, 3.116, modified—added ‘or accessory’ and deleted note.]
3.9
single-patient reuse
capable of being used multiple times on the same patient
4 Information to be supplied by the manufacturer
4.1 General
Masks, headgear and other accessories shall be provided with an accompanying document. The
accompanying document shall be regarded as a part of masks, headgear and the accessories.
NOTE 1 The purpose of an accompanying document is to promote the safe use of a mask, headgear or other
accessory during the expected useful life.
NOTE 2 Annex H contains a guide to assist the reader in locating the marking and labelling requirements
contained in other clauses of ISO 17510.
4.2 Marking on the protective packaging
Packages of masks, headgear and other accessories shall be marked with:
a) name or trade name and address of
— the manufacturer, and
— where the manufacturer does not have an address within the locale, an authorized
representative within the locale,
to which the operator or responsible organization can refer;
b) the details strictly necessary to identify the device and the contents of the packaging especially for
the operator or responsible organization;
c) the identity and intended purpose of the mask and any application accessories;
d) any special storage and/or handling conditions;
e) any special operating instructions;
f) any special warnings and/or precautions to be taken;
g) if applicable, symbol from ISO 15223-1:2012, 5.1.4 indicating the latest date by which the mask and
any application accessories can be used safely (i.e. shelf life), expressed as the year, month and
day;
h) identification reference to the batch, type or serial number with symbol from ISO 15223-1:2012,
5.1.7 with an accompanying serialization or symbol from ISO 15223-1:2012, 5.1.5 with an
accompanying lot or batch identifier; and
i) for sterile items, with symbol ISO 15223-1:2012, 5.2.1, symbol ISO 15223-1:2012, 5.2.2, symbol
ISO 15223-1:2012, 5.2.3 or symbol ISO 15223-1:2012, 5.2.4, as appropriate.
Packaging for single use masks, headgear and other accessories shall be marked accordingly and
shall be consistent for a model or type reference.
ISO 17510:2015(E)
Check compliance by inspection without opening the packaging.
4.3 Accompanying document
The accompanying document of the mask, headgear, or other accessory shall contain the following
information:
a) name or trade name and address of
— the manufacturer; and
— where the manufacturer does not have an address within the locale, an authorized
representative within the locale,
to which the operator or responsible organization can refer;
b) the identity and the intended purpose of the mask and any application accessories;
c) the details of any treatment or handling needed before the mask or accessory can be used;
d) if provided sterile,
— an indication of the method of sterilization using symbol ISO 15223-1:2012, 5.2.1, symbol
ISO 15223-1:2012, 5.2.2, symbol ISO 15223-1:2012, 5.2.3 or symbol ISO 15223-1:2012, 5.2.4, as
appropriate;
— instructions necessary in the event of damage to the sterile packaging and details of appropriate
methods of resterilization;
e) if the packaging contains more than one component information necessary for correct assembly of
the components;
f) information necessary to verify whether the mask or accessory is properly installed and can
operate correctly and safely;
g) 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”;
h) 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);
i) if applicable, information about the means provided to minimize rebreathing (see 5.3);
j) the rated pressure range of the mask including any connecting element;
k) information to enable the responsible organization (prescriber) to inform the patient of
— any potential contraindications and any precautions that might need to be taken,
— any precautions to be taken in the event of changes in performance, and
— any precautions to be taken regarding to risks associated with disposal;
l) if specified for reuse:
— the information specified in ISO 17664:2004, 3.9, if sterilizable;
— 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 accompanying documents, or
4 © ISO 2015 – All rights reserved

ISO 17510:2015(E)
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”;
m) information about the nature and frequency of regular and preventative maintenance of the mask
or accessory, including information about the replacement of consumable components during the
expected useful life of the mask or accessory;
n) information for the operator to identify parameters or criteria that could 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 as a result of this identification (e.g. disposal or component replacement procedure);
o) the expected useful life of masks and any accessories;
p) * the resistance, derived from pressure drop, between the mask and the patient-connection port
at flowrates of 50 l/min and 100 l/min, as determined in Annex C;
q) * for masks that cover the nose and the mouth, the inspiratory, and expiratory resistance of the
mask in combination with the anti-asphyxia valve open to atmosphere, as determined in Annex E;
r) * the pressure-flow curve of the exhaust flow throughout the working pressure range as
determined in Annex B;
s) * the date of issue or revision level of the accompanying document.
Check compliance by inspection of the accompanying document.
5 Construction requirements
5.1 Mask connectors
Mask connectors, if conical, shall be 15 mm or 22 mm size male connectors conforming to
ISO 5356-1:2015 or ISO 5356-2:2012.
Non-conical mask connectors shall not engage with conical connectors conforming to ISO 5356-1:2015
or ISO 5356-2:2012, unless they comply with the engagement, disengagement, and leakage requirements
of ISO 5356-1:2015 or ISO 5356-2:2012.
Check compliance by inspection and functional testing.
5.2 Biocompatibility
Parts or materials that are intended to be in contact with the patient or patient gas pathway during
normal use shall be evaluated according to ISO 10993-1:2009.
NOTE 1 The gas pathways should be evaluated to ISO 18562-1:—, upon its publication.
Parts or materials that are intended to be inserted into the nares or the mouth shall be evaluated as
mucosal membrane contact.
For parts or materials not intended to be inserted into the nares or mouth (e.g. mask elbows, tubing,
cushions, and faceplates), the gas pathway materials shall be evaluated as skin contact.
For mask materials, including headgear, intended to contact the patient’s head, the materials shall be
evaluated as skin contact.
All materials shall be considered as for permanent duration contact as categorized in ISO 10993-1:2009.
NOTE 2 Permanent duration contact is required because sleep apnoea breathing therapy equipment and
accessories have cumulative usage that is greater than 30 d.
Natural rubber latex shall not be used in the mask or accessories.
ISO 17510:2015(E)
The manufacturer of a mask or accessories shall address in the risk management process the
risks associated with the leaching or leaking of substances into the gas pathway. Special attention shall
be given to substances which are carcinogenic, mutagenic, or toxic to reproduction.
A mask or accessory that contains phthalates which are classified as carcinogenic, mutagenic or toxic
to reproduction shall be marked on the mask or accessory itself or on the packaging that it contains
phthalates. If the intended use of a mask or accessory includes treatment of children or treatment of
pregnant or nursing women, a specific justification for the use of these phthalates shall be included in
the risk management file. The accompanying document of a mask or accessory that contains such
phthalates shall contain information on residual risks for these patient groups and, if applicable, on
appropriate precautionary measures.
Check compliance by the application of ISO 10993-1:2009, inspection of the accompanying document
and inspection of the risk management file for identification of the presence of substances which are
carcinogenic, mutagenic or toxic to reproduction and justification for their use.
5.3 * Protection against rebreathing
5.3.1 Normal condition protection
Means shall be provided to minimize the risk of rebreathing during normal condition. The means
may be integral to the mask or other application accessory or located in the sleep apnoea breathing
therapy equipment.
Under normal condition, the relative CO increase shall not exceed 20 % when tested at
— the minimum rated pressure,
— a pressure of 5 hPa (5 cmH O), and
— a pressure of 10 hPa (10 cmH O).
Check compliance by the tests described in Annex F.
5.3.2 Single fault condition protection
Masks that cover the mouth shall be designed to minimize rebreathing during single fault
condition.
Under single fault condition, the relative CO increase shall not exceed 60 % when tested
— with blockage of the breathing tube, and
— at the equipment-end of the breathing tube open to atmosphere.
NOTE Patients can open their mouth and breathe normally under single fault condition for a mask that
only covers the nose.
Check compliance by the tests described in Annex F.
5.4 Cleaning, disinfection, and sterilization
The mask and any accessories, whether for single-patient reuse or multi-patient reuse, shall
be designed so that contaminant-trapping features are minimized and can be easily cleaned by the
operator.
The mask and any accessories and their parts intended for multi-patient reuse shall be so
constructed that they can be cleaned and disinfected or cleaned and sterilized.
6 © ISO 2015 – All rights reserved

ISO 17510:2015(E)
Processing or (re)processing methods for cleaning and disinfection of a mask and any accessories
and their parts shall be validated using the number of cleaning or cleaning and disinfection cycles
that represents their expected useful life.
Processing or (re)processing instructions disclosed in the accompanying document for the mask
and any accessories and their parts shall comply with ISO 17664:2004 and ISO 14937:2009. The mask
and any accessories labelled sterile shall have been sterilized using an appropriate, validated method
as described in ISO 14937:2009.
Non-sterile packaging systems shall be designed to maintain contents, which are intended to be
sterilized before use, at their intended level of cleanliness.
Check compliance by inspection of accompanying document and review of the validation of the processing
methods, including the verification that the mask and any accessories and their parts comply with their
specifications after re-processing.
5.5 * Breathing during single fault condition
For masks that cover the mouth, means shall be provided to limit inspiratory and expiratory resistance
in single fault condition. The resistance to flow shall not exceed 10 hPa (10 cmH O) (measured at the
patient-connection port) at a flowrate of 50 l/min.
If an anti-asphyxia valve is provided, the open-to-atmosphere pressure shall be less than the
minimum rated pressure of the mask. The open-to-atmosphere and closed-to-atmosphere pressures
shall be disclosed in the accompanying document.
NOTE Patients can open their mouth and breathe normally under single fault condition for a mask that
only covers the nose.
Check compliance by inspection of accompanying document and using the tests described in Annex D and
Annex E.
5.6 Breathing system filter
Any breathing system filter shall comply with ISO 23328-1:2003 and ISO 23328-2:2002.
Check compliance by application of the requirements of ISO 23328-1:2003 and ISO 23328-2:2002.
6 Vibration and noise
The A-weighted sound power level caused by the mask and any accessories shall be measured and
disclosed in the accompanying document in accordance with ISO 4871:1996 and ISO 3744:2010 using
engineering-method grade 2. The A-weighted sound pressure level in accordance with ISO 4871:1996
and ISO 3744:2010 at a distance of 1 m shall also be disclosed in the accompanying document.
NOTE Care is required in the test setup to ensure that the sound measurement of the mask and any
accessories is not interfered with by the noise emitted by the breathing tube or the equipment.
Check compliance by inspection of accompanying document and the tests in Annex G.
ISO 17510:2015(E)
Annex A
(informative)
Particular guidance and rationale
A.1 General guidance
This Annex provides rationale for some requirements of this International Standard and is intended for
those who are familiar with the subject of this International Standard but who have not participated
in its development. An understanding of the rationales underlying these requirements is considered
to be essential for their proper application. Furthermore, as clinical practice and technology change,
it is believed that a rationale will facilitate any revision of this document necessitated by those
developments.
Figure A.1 is a typical example of a series of component arrangements of ISO 80601-2-70 and ISO 17510.
It is intended to enhance comprehension of the combination of sleep apnoea breathing therapy
equipment and masks and application accessories, as well as to clarify the scope of the related
standards.
Sleep apnoea breathing therapy equipment is usually combined with a mask and application
accessories of different manufacturers. Whereas most sleep apnoea breathing therapy
equipment is pressure-adjustable at the patient-connection port, all connected accessories and
masks are outside the area where pressure is controlled. Therefore, these masks have direct impact
on the therapeutic pressure received by the patient. An important mechanism whereby sleep apnoea
breathing therapy equipment benefits the patient is by increasing the cross-sectional area of the
pharynx and decreasing the collapsibility of the upper airway. Sleep apnoea breathing therapy
equipment is intended to deliver a therapeutic pressure to the patient by means of masks and/or
application accessories.
The resistance of masks and accessories connected to sleep apnoea breathing therapy equipment
depends on respiratory flowrate. High inspiratory peak flows, in particular, can cause a substantial
pressure drop between the patient-connection port and the patient’s airway. Consequently, the
patient does not receive the required therapeutic pressure, the probability of obstructive apnoea
is increased, and the therapeutic objective is not achieved. Furthermore, sleep apnoea breathing
therapy equipment relies on both the design of the sleep apnoea breathing therapy equipment to
minimize the risk of asphyxia and the defence mechanism of the patient to respond to single fault
conditions and arouse the patient from sleep, thereby allowing the patient to avoid potential harm.
Therefore, this International Standard deals extensively with the performance standard for sleep
apnoea breathing therapy equipment to ensure the delivery of the therapeutic pressure and prevent
asphyxia.
The requirements and test methods stated serve to provide guidance to responsible organizations
and operators when selecting appropriate sleep apnoea breathing therapy equipment, masks,
accessories and the combination thereof, and to ensure compatibility of the masks and accessories
with sleep apnoea breathing therapy equipment.
8 © ISO 2015 – All rights reserved

ISO 17510:2015(E)
Key
1 headgear
2 mask
3 connecting element (optional)
4 patient-connection port
5 breathing tube
6 gas output port connector of the sleep apnoea breathing therapy equipment
7 sleep apnoea breathing therapy equipment with or without humidifier
8 scope of ISO 17510
9 scope of ISO 80601-2-70
NOTE The exhaust port can be located in the connecting element (3), the mask (2), or the sleep apnoea
breathing therapy equipment (6).
Figure A.1 — Relationship of the components of sleep apnoea breathing therapy equipment
and masks and application accessories and the related standards
A.2 Rationale for particular clauses and subclauses
The numbering of the following rationales corresponds to the numbering of the clauses in this
International Standard. The numbering is, therefore, not consecutive.
Subclause 4.3 — Accompanying document
p)
The exhaust flow comprises flow through all orifices in the mask and accessories (including the
exhaust port).
Exhaust flow and the derived pressure-flow curve are important characteristics of the mask which
assist the supervising clinician or the healthcare professional operator in assessing the compatibility
of the mask with other equipment. The relationship between the pressure provided to the patient and
the exhaust flow is measured and included in the labelling.
The settings chosen for the test were selected to be consistent with ISO 80601-2-70:2015, Table 201.104.
q)
The total resistance to flow in sleep apnoea breathing therapy equipment and masks and
application accessories comprises the resistance up to the patient-connection port, plus the
resistance of the mask and application accessories from the patient-connection port to the patient.
ISO 17510:2015(E)
The resistance up to the patient-connection port is addressed in equipment design in ISO 80601-2-
70:2015. The resistance of the mask and application accessories from the patient-connection port
to the patient is an important characteristic that assists the responsible organization in assessing
the compatibility of the mask and application accessories with other equipment.
The resistance of the mask and application accessories changes with the flow, and this relationship
depends on the design. Therefore, a single measurement point is not adequate. The resistance is
measured at two typical flows at the patient-connection port (50 l/min and 100 l/min).
The pressure drop is provided, rather than the calculated resistance. Pressure drop is more useful to
the supervising clinician or the healthcare professional operator.
Specifying the resistance to flow of the mask and application accessories allows the supervising
clinician or the healthcare professional operator to specify compatible sleep apnoea breathing
therapy equipment.
r)
Specifying the inspiratory resistance of the anti-asphyxia valve of the mask at a very low flowrate
allows the supervising clinician or the healthcare professional operator to specify compatible sleep
apnoea breathing therapy equipment so that the anti-asphyxia valve closes when needed. Annex E
contains additional information.
Specifying the expiratory resistance of the anti-asphyxia valve of the mask allows the supervising
clinician or the healthcare professional operator to specify compatible sleep apnoea breathing
therapy equipment so that the anti-asphyxia valve closes when needed. Annex E contains additional
information.
Subclause 5.3 — Protection against rebreathing
Masks and other patient interfaces intended for use with sleep apnoea breathing therapy
equipment without an active exhalation valve incorporate an exhaust port. The function of the
exhaust ports is to allow for passive removal of exhaled gases to minimize rebreathing.
A critical issue to be considered is whether the machine-patient flow through the exhaust port has
reduced the residual exhaled CO to acceptable levels.
Most sleep apnoea breathing therapy equipment is equipped with a single-conduit breathing gas
pathway with a dual-purpose, inspiratory/expiratory function and an exhaust port. The issue of CO
rebreathing will be a function of several variables, such as the following:
— the type of the breathing attachment — face mask, nasal mask, or full face mask;
— the size and location of the exhaust ports;
— the average flowrate at the minimum CPAP pressure;
NOTE The average flowrate is measured in ISO 80601-2-70:2015, Annex C and recorded in Table C.1,
which allows the supervising clinician or the healthcare professional operator to assess the potential for
rebreathing.
— the duration of the patient’s exhalation.
There is the potential for clinically significant CO rebreathing if the exhaust ports are not designed
and located appropriately. Therefore, the design and configuration of sleep apnoea breathing therapy
equipment and its masks and accessories h
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