EN ISO 17510:2025

SLOVENSKI STANDARD
oSIST prEN ISO 17510:2025
01-februar-2025
Medicinski pripomočki - Zdravljenje dihanja pri spalni apneji - Maske in oprema za
nameščanje (ISO/DIS 17510:2024)
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
(ISO/DIS 17510:2024)
Medizinische Geräte - Schlafapnoe-Atemtherapie - Masken und Anwendungszubehör
(ISO/DIS 17510:2024)
Dispositifs médicaux - Thérapie respiratoire de l'apnée du sommeil - Masques et
accessoires d'application (ISO/DIS 17510:2024)
Ta slovenski standard je istoveten z: prEN ISO 17510
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 17510:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 17510:2025
oSIST prEN ISO 17510:2025
DRAFT
International
Standard
ISO/DIS 17510
ISO/TC 121/SC 3
Medical devices — Sleep apnoea
Secretariat: ANSI
breathing therapy — Masks and
Voting begins on:
application accessories
2024-12-09
Dispositifs médicaux — Thérapie respiratoire de l'apnée du
Voting terminates on:
sommeil — Masques et accessoires d'application
2025-03-03
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 17510:2024(en)
oSIST prEN ISO 17510:2025
DRAFT
ISO/DIS 17510:2024(en)
International
Standard
ISO/DIS 17510
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
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 17510:2024(en)
ii
oSIST prEN ISO 17510:2025
ISO 17510
1 Contents Page
2 Foreword . 6
3 Introduction . 7
4 1 Scope . 1
5 2 Normative references . 1
6 3 Terms and definitions . 2
7 4 Information supplied by the manufacturer . 4
8 4.1 General . 4
9 4.2 Accompanying information . 4
10 5 Construction requirements . 6
11 5.1 Mask connectors . 6
12 5.2 Biocompatibility . 6
13 5.2.1 Patient contacting . 6
14 5.2.2 Gas pathway contacting . 7
15 5.3 Protection against rebreathing . 7
16 5.3.1 Normal condition protection . 7
17 5.3.2 Single fault condition protection. 8
18 5.4 Cleaning, disinfection, and sterilization . 8
19 5.4.1 Single patient multiple use . 8
20 5.4.2 Multiple patient multiple use . 9
21 5.5 Breathing during single fault condition .10
22 5.6 Breathing system filter .10
23 6 Audible acoustic energy .10
24 7 Measurement uncertainty .11
25 Annex A (informative) Particular guidance and rationale .12
26 A.1 General guidance .12
27 A.2 Rationale for particular clauses and subclauses .13
28 Annex B (normative) Exhaust flow test procedure .17
29 B.1 Principle .17
30 B.2 Apparatus .17
31 B.3 Procedure .17
32 Annex C (normative) Resistance to flow (pressure drop) .19
33 C.1 Principle .19
34 C.2 Apparatus .19
35 C.3 Procedure .19
36 Annex D (normative) Anti-asphyxia valve pressure testing .21
37 D.1 Principle .21
38 D.2 Apparatus .21
iv © ISO 2024 – All rights reserved

oSIST prEN ISO 17510:2025
ISO 17510
39 D.3 Procedure for determining the opening pressure . 22
40 D.4 Procedure for determining the closing pressure . 22
41 Annex E (normative) Determination of the inspiratory and expiratory pressure
42 drop under single fault condition . 23
43 E.1 Principle . 23
44 E.2 Apparatus . 23
45 E.3 Procedure . 24
46 Annex F (normative) Carbon Dioxide rebreathing . 25
47 F.1 Principle . 25
48 F.2 Apparatus . 25
49 F.3 Procedure . 25
50 Annex G (normative) Audible acoustic energy . 28
51 G.1 Principle . 28
52 G.2 Apparatus . 28
53 G.3 Procedure . 28
54 Annex H (informative) Guide to information supplied by the manufacturer . 30
55 H.1 Accompanying information for mask or accessory . 30
56 Annex I (informative) Reference to the IMDRF essential principles and
57 labelling guidances . 31
58 Annex J (informative) Terminology — alphabetized index of defined terms . 34
59 Bibliography . 36
oSIST prEN ISO 17510:2025
ISO 17510
61 Foreword
62 ISO (the International Organization for Standardization) is a worldwide federation of national standards
63 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
64 through ISO technical committees. Each member body interested in a subject for which a technical
65 committee has been established has the right to be represented on that committee. International
66 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
67 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
68 electrotechnical standardization.
69 The procedures used to develop this document and those intended for its further maintenance are
70 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
71 different types of ISO documents should be noted. This document was drafted in accordance with the
72 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
73 Attention is drawn to the possibility that some of the elements of this document may be the subject of
74 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
75 patent rights identified during the development of the document will be in the Introduction and/or on
76 the ISO list of patent declarations received (see www.iso.org/patents).
77 Any trade name used in this document is information given for the convenience of users and does not
78 constitute an endorsement.
79 For an explanation on the meaning of ISO specific terms and expressions related to conformity
80 assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers
81 to Trade (TBT) see the following URL: Foreword - Supplementary information
82 The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
83 Subcommittee SC 3, Respiratory devices and related equipment for patient care.
84 This second edition cancels and replaces the first edition of ISO 17510:2015 which has been technically
85 revised with the following changes:
86 — harmonization with IEC 60050-880, where appropriate ;
87 — adding disclosure requirements for magnets in headgear;
88 — updated processing requirements;
89 — updated vibration and noise requirements;
90 — referencing ISO 18562-1, for biocompatibility of gas pathways; and
91 — harmonization with ISO 20417, where appropriate.
vi © ISO 2024 – All rights reserved

oSIST prEN ISO 17510:2025
ISO 17510
92 Introduction
93 Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during
94 sleep. The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As
95 a result, the use of sleep apnoea breathing therapy equipment has become common. This document covers
96 basic safety and essential performance requirements for masks and other application accessories needed
97 to protect patients during use of this equipment.
98 In this document, the following print types are used:
99 — requirements and definitions: roman type;
100 — informative material appearing outside of tables, such as notes, examples, and references: in smaller type. Normative text
101 of tables is also in a smaller type;
102 — Terms defined in Clause 3 in this document or as noted: italics.
103 In referring to the structure of this document, the term
104 — “clause” means one of the numbered divisions within the table of contents, inclusive of all
105 subdivisions (e.g. Clause 5 includes 5.1, 5.2, etc.), and
106 — “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2, and 5.3.1 are all subclauses of
107 Clause 5).
108 References to clauses within this document are preceded by the term “Clause” followed by the clause
109 number. References to subclauses within this particular document are by number only.
110 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
111 of the conditions is true.
112 In this document, the following verbal forms are used:
113 — “shall” indicates a requirement;
114 — “should” indicates a recommendation;
115 — “may” indicates a permission; and
116 — "can" is used to describe a possibility or capability.
oSIST prEN ISO 17510:2025
oSIST prEN ISO 17510:2025
DRAFT INTERNATIONAL STANDARD ISO 17510

117 Medical devices — Sleep apnoea breathing therapy — Masks and
118 application accessories
119 1 Scope
120 This document applies to masks and their accessories used to connect sleep apnoea breathing therapy
121 equipment to the patient. It specifies requirements for masks and accessories, including any connecting
122 element, that are required to connect the patient-connection port of sleep apnoea breathing therapy
123 equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust
124 ports and headgear).
125 Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the typical
126 elements of this document together with the sleep apnoea breathing therapy equipment of
127 ISO 80601-2-70 that form a sleep apnoea breathing system.
128 This document does not cover oral appliances.
[8] [9]
129 NOTE This document has been prepared to address the relevant essential principles and labelling principles
130 guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB.
131 2 Normative references
132 The following documents, in whole or in part, are normatively referenced in this document and are
133 indispensable for its application. For dated references, only the edition cited applies. For undated
134 references, the latest edition of the referenced document (including any amendments) applies.
135 ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
136 using sound pressure — Engineering methods for an essentially free field over a reflecting plane
137 ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
138 equipment
139 ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
140 sockets
141 ISO 5356-2:2012, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
142 weight-bearing connectors
143 ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
144 management process
145 ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
146 sterilizing agent and the development, validation and routine control of a sterilization process for medical
147 devices
148 ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
149 manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
oSIST prEN ISO 17510:2025
ISO 17510
150 ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
151 manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
152 ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
153 Part 1: Evaluation and testing within a risk management process
154 ISO 20417:— , Medical devices — Information to be supplied by the manufacturer
155 ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
156 to assess filtration performance
157 ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
158 aspects
159 IEC 60050-880:— , International Electrotechnical Vocabulary (IEV) – Part 880: Electrical equipment,
160 electrical systems and software used in healthcare
161 IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
162 IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in the
163 electrotechnical sector
164 3 Terms and definitions
165 For the purposes of this document, the terms and definitions given in IEC 60050-880:— as indicated in
166 Annex J and the following apply.
167 NOTE An alphabetical index of defined terms is found in Annex J.
168 3.1
169 anti-asphyxia valve
170 valve used on a breathing mask intended to allow spontaneous breathing when the lung ventilator or
171 breathing therapy equipment is not providing adequate pressure or flow
172 [SOURCE: ISO 4135:2022, 3.6.3.7]
173 3.2
174 breathing system filter
175 BSF
176 device intended to reduce transmission of particulates, including microorganisms, in a breathing system
177 [SOURCE: ISO 4135:2022, 3.6.1.5]
178 3.3
179 breathing tube
180 non-rigid tube used to convey gases or vapours within the user-detachable section of a breathing system
181 [SOURCE: ISO 4135:2022, 3.1.4.4, modified —deleted note.]

Under preparation. Stage at the time of publication: ISO/DIS 20417:2024.
Under preparation. Stage at the time of publication: IEC/CDV 60050-880:2024.
2 © ISO 2024 – All rights reserved

oSIST prEN ISO 17510:2025
ISO 17510
182 3.4
183 exhaust flow
184 flow from the mask or application accessory to atmosphere other than the leak due to improper seal to
185 the face
186 Note 1 to entry: The exhaust flow can pass through openings in the mask, the connecting element and the mask or
187 through the anti-asphyxia valve.
188 Note 2 to entry: The exhaust flow discharges exhaled gases to atmosphere to reduce rebreathing of CO2.
189 [SOURCE: ISO 4135:2022, 3.8.1.3]
190 3.5
191 exhaust port
192 port through which gas is discharged to the atmosphere or to an anaesthetic gas scavenging system
193 [SOURCE: ISO 4135:2022, 3.1.4.11, modified —deleted notes.]
194 3.6
195 gas output port
196 port of the device through which gas is delivered at respiratory pressures to a user-detachable part of a
197 breathing system
198 [SOURCE: ISO 4135:2022, 3.1.4.22, modified —deleted note.]
199 3.7
200 headgear
201 part that is used to fix the mask to the patient
202 Note 1 to entry: The headgear may be an integral part of the mask.
203 3.8
204 mask
205 device which provides a non-invasive interface between the patient's airway and a patient-connection
206 port or other connection to a source of respirable gas
207 [SOURCE: ISO 4135:2022, 3.8.6.4]
208 3.9
209 oral appliance
210 device intended to maintain the oral airway by mechanical means and which achieves its purpose
211 independently of sleep apnoea breathing therapy equipment
212 3.10
213 patient-connection port
214 port of a breathing system intended for connection to an airway device
215 Note 1 to entry: The patient-connection port is the end of the breathing system proximal to the patient.
216 Note 2 to entry: The patient-connection port is typically a connector suitable for connection to an airway device such
217 as a tracheal tube, tracheostomy tube, face mask or supralaryngeal airway.
218 Note 3 to entry: Current product standards typically specify that the patient-connection port is required to be in the
219 form of specific standardized connectors, for example, a connector conforming to ISO 5356-1.
oSIST prEN ISO 17510:2025
ISO 17510
220 Note 4 to entry: In anaesthetic and respiratory equipment where its function is dependent upon a design feature of
221 the component that connects the equipment to the patient's airway, then there is no patient-connection-port.
222 Examples would include non-invasive ventilation using a face mask (with an integrated expiratory port, or oxygen
223 therapy using an open mask.
224 [SOURCE: ISO 4135:2022, 3.1.4.41]
225 3.11
226 rebreathing
227 inhalation of expired gas mixture from which carbon dioxide may or may not have been removed
228 [SOURCE: ISO 4135:2022, 3.1.5.12]
229 3.12
230 sleep apnoea breathing therapy equipment
231 ME equipment delivering a therapeutic breathing pressure to the patient intended to treat obstructive
232 sleep apnoea by keeping the upper airways open
233 Note 1 to entry: Sleep apnoea breathing therapy equipment is primarily used in the home healthcare environment by
234 a lay user without direct professional supervision.
235 [SOURCE: ISO/DIS 80601-2-70:2024, 201.3.259]
236 4 Information supplied by the manufacturer
237 4.1 General
238 a) Masks, headgear and their accessories shall be provided with accompanying information.
239 b) The accompanying information shall be regarded as a part of masks, headgear and their accessories.
240 c) The information supplied by the manufacturer of masks, headgear and their accessories shall conform
241 with ISO 20417:2021.
242 NOTE 1 The purpose of an accompanying information is to promote the safe use of a mask, headgear or their
243 accessories during the expected lifetime.
244 NOTE 2 Annex H contains a guide to assist the reader in locating the information supplied by the manufacturer
245 requirements contained in other clauses of ISO 17510.
246 d) Check conformity by inspection of the information supplied by the manufacturer.
247 4.2 Accompanying information
248 NOTE 1 There is guidance or rationale for this subclause contained in Clause A.2.
249 a) The accompanying information of the mask, headgear, or other accessory shall contain the following
250 information:
251 1) if the packaging contains more than one component, information necessary for correct assembly
252 of the components;
4 © ISO 2024 – All rights reserved

oSIST prEN ISO 17510:2025
ISO 17510
253 2) if the mask or accessory includes an exhaust port, a warning statement to the effect that:
254 “WARNING: Occlusion of the exhaust needs to be prevented to avoid having an adverse effect on
255 the safety and quality of the therapy”;
256 3) a statement to the effect that combination with other medical devices not intended to be
257 combined with the mask can decrease the safety or alter the performance of the mask (e.g. in
258 combination with a humidifier for medical use, nebulizer, heat and moisture exchanger (HME),
259 filters, bi-level positive airway pressure equipment, self-adjusting equipment, or additional
260 oxygen supply or any exhaust port);
261 4) if applicable, information about the means provided to minimize rebreathing (see 5.3);
262 5) the rated pressure range of the mask including any connecting element;
263 6) if specified for reuse, a warning statement to the effect that: “WARNING: frequency of cleaning,
264 methods of cleaning or the use of cleaning agents, other than those specified in the instructions
265 for use, or exceeding the number of processing cycles can have an adverse effect on the [place
266 name of component here] and consequently the safety or the quality of the therapy”;
267 7) information for the user to identify parameters or criteria that could indicate a safety or efficacy
268 change in the mask or accessory (e.g. visual inspection criteria); as well as the course of action to
269 follow because of this identification (e.g. disposal or component replacement procedure);
270 8) the shelf life of masks and their accessories;
271 9) the expected lifetime of masks and their accessories;
272 10) the pressure drop, between the patient airway interface of the mask and the patient-connection
273 port at flowrates of 50 l/min and 100 l/min, as determined in Annex C;
274 NOTE 2 There is guidance or rationale for this list element contained in Clause A.2.
275 11) for masks that cover the nose and the mouth, the inspiratory, and expiratory pressure drop of
276 the mask in combination with the anti-asphyxia valve open to atmosphere, as determined in
277 Annex E;
278 NOTE 3 There is guidance or rationale for this list element contained in Clause A.2.
279 12 the pressure-flow curve of the exhaust flow throughout the working pressure range as
280 determined in Annex B;
281 NOTE 4 There is guidance or rationale for this list element contained in Clause A.2.
282 13) for headgear and masks with magnets, the maximum magnetic flux density at the worst-case
283 location of normal use, both when:
284 i) assembled; and
285 ii) dis assembled;
286 iii) IEC 60404-5 may be used to determine the magnetic flux density.
287 14) for headgear and masks with magnets, a warning statement to the effect that: “WARNING: keep
288 the headgear and their magnets away from devices and implants that can be affected by magnetic
289 fields; and
oSIST prEN ISO 17510:2025
ISO 17510
290 i) Safety sign W006 of ISO 7010 may be used.
291 15) for headgear and masks with magnets, a disclosure to the effect: Use of the mask is
292 contraindicated for patients and their household members, caregivers, and bed partners that are
293 in close vicinity to patients using the mask, that have implanted devices with metallic
294 components that are susceptible to magnetic fields, including but not limited to the following.
295 — Pacemakers
296 — Implantable cardioverter defibrillators (ICD)
297 — Neurostimulators
298 — Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e.
299 neck and head)
300 — CSF (cerebral spinal fluid) shunts [e.g., VP (ventriculo peritoneal) shunt]
301 — Aneurysm clips
302 — Embolic coils
303 — Intracranial aneurysm intravascular flow disruption devices
304 — Metallic cranial plates, screws, burr hole covers, and bone substitute devices
305 — Metallic splinters in the eye
306 — Ocular implants (e.g., glaucoma implants, retinal implants)
307 — Certain contact lenses with metal
308 — Implants to restore hearing or balance that have an implanted magnet (such as cochlear
309 implants, implanted bone conduction hearing devices, and auditory brainstem implants)
310 — Magnetic denture attachments
311 — Metallic gastrointestinal clips
312 — Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
313 — Implantable ports and pumps (e.g., insulin pumps)
314 — Hypoglossal Nerve Stimulators
315 — Devices labelled as MR (magnetic resonance) unsafe
316 — Magnetic metallic implants not labelled for MR or not evaluated for safety in a magnetic field.
317 b) Check conformity by inspection of the accompanying information.
318 5 Construction requirements
319 5.1 Mask connectors
320 a) Mask connectors, if conical, shall be 15 mm or 22 mm size cone connectors conforming to
321 ISO 5356-1:2015 or ISO 5356-2:2012.
322 b) Non-conical mask connectors shall not engage with conical connectors conforming to
323 ISO 5356-1:2015 or ISO 5356-2:2012, unless they comply with the engagement, disengagement, and
324 leakage requirements of ISO 5356-1:2015 or ISO 5356-2:2012.
325 c) Check conformity by inspection and functional testing.
326 5.2 Biocompatibility
327 5.2.1 Patient contacting
328 a) Parts or materials that are intended to be in contact with the patient during normal use shall be
329 evaluated in accordance with ISO 10993-1:2018.
6 © ISO 2024 – All rights reserved

oSIST prEN ISO 17510:2025
ISO 17510
330 1) Parts or materials that are intended to be inserted into the nares or the mouth shall be evaluated
331 as mucosal membrane contact.
332 EXAMPLE 1 Nasal cannula
333 2) For parts or materials not intended to be inserted into the nares or mouth, the materials shall be
334 evaluated as skin contact.
335 EXAMPLE 2 Most nasal pillow cushions, mask elbows, tubing, cushions, and faceplates.
336 i) Parts that are not in patient contact during therapy, may be classified as handling contact
337 only, and assessed in accordance with the note in ISO 10993-1:2018, 5.2.2 a).
338 3) For mask materials, including headgear, intended to contact the patient's head, the materials
339 shall be evaluated as skin contact.
340 b) All materials shall be considered as for long term exposure as categorized in ISO 10993-1:2018.
341 NOTE 2 Long term exposure is required because sleep apnoea breathing therapy equipment and accessories
342 have cumulative usage that is greater than 30 d.
343 c) Natural rubber latex shall not be used in the mask or accessories.
344 d) Check conformity by the application of ISO 10993-1:2018 and ISO 18562-1:2024.
345 5.2.2 Gas pathway contacting
346 a) The manufacturer of a mask or accessories shall address in the risk management process the risks
347 associated with the leaching or leaking of substances into the gas pathway.
348 b) The gas pathways shall be evaluated for biocompatibility in accordance with ISO 18562-1:2024.
349 1) All materials shall be considered as for long term exposure as categorized in ISO 18562-1:2024.
350 NOTE Long term exposure is required because sleep apnoea breathing therapy equipment and accessories
351 have cumulative usage that is greater than 30 d.
352 c) Check conformity by the application of ISO 18562-1:2024.
353 5.3 Protection against rebreathing
354 NOTE There is guidance or rationale for this subclause contained in Clause A.2.
355 5.3.1 Normal condition protection
356 a) Means shall be provided to minimize the risk of rebreathing during normal condition.
357 1) The means may be integral to the mask or other application accessory or located in the sleep
358 apnoea breathing therapy equipment.
359 b) Under normal condition, the relative CO increase shall not exceed 20 % when tested at the worst-
360 case rated pressure.
361 NOTE The worst-case rated pressure is typically the minimum rated pressure.
oSIST prEN ISO 17510:2025
ISO 17510
362 c) Check conformity by the tests described in Annex F.
363 5.3.2 Single fault condition protection
364 a) Masks that cover the mouth shall be designed to minimize rebreathing during single fault condition.
365 b) Under single fault condition, the relative CO increase shall not exceed 60 % when tested:
366 1) with blockage of the breathing tube; and
367 2) at the equipment-end of the breathing tube open to atmosphere.
368 NOTE Patients can open their mouth and breathe normally under single fault condition for a mask that only
369 covers the nose.
370 c) Check conformity by the tests described in Annex F.
371 5.4 Cleaning, disinfection, and sterilization
372 5.4.1 Single patient multiple use
373 a) The single patient multiple use mask and any accessories use shall be designed so that contaminant-
374 trapping features are minimized and can be easily cleaned by the user.
375 b) The gas pathways of masks and any accessories and their parts intended for single patient multiple
376 use that can become contaminated with body fluids or by contaminants carried by expired gases
377 during normal condition or single fault condition shall be so constructed to allow:
378 1) for cleaning; or
379 2) for cleaning and disinfection.
380 c) These processing instructions for the gas pathways that can become contaminated shall:
381 1) conform with ISO 17664-1:2021; and
382 2) be disclosed in the accompanying information.
383 d) The non-gas pathways of masks and any accessories and their parts intended for single patient
384 multiple use shall be so constructed that allow for
385 1) surface cleaning; or.
386 2) surface cleaning and disinfection.
387 e) These processing instructions for the non-gas pathways shall:
388 1) conform with ISO 17664-2:2021; and
389 2) be disclosed in the accompanying information.
390 d) Processing methods for a mask and any accessories and their parts shall be validated using the number
391 of cleaning and disinfection cycles that represents their expected lifetime.
8 © ISO 2024 – All rights reserved

oSIST prEN ISO 17510:2025
ISO 17510
392 f) Processing methods for a mask and any accessories and their parts shall maintain their specifications
393 following multiple processing cycles that represents their expected lifetime.
394 g) Processing methods for a mask and any accessories and their parts shall maintain cleaning and
395 disinfection efficacy for six cycles.
396 h) Check conformity by inspection of accompanying information and the following.
397 1) Perform the processing for the number of cycles determined by the expected lifetime in
398 accordance with the methods indicated in the accompany document, including any cooling or
399 drying period.
400 2) After these procedures, verify that the mask and any accessories and their parts conform with
401 their specifications.
402 3) Confirm the efficacy of six cycles of simulated use including soiling and processing.
403 5.4.2 Multiple patient multiple use
404 a) The multiple patient multiple use mask and any accessories shall be designed so that contaminant-
405 trapping features are minimized and can be easily cleaned by the user.
406 b) The gas pathways of masks and any accessories and their parts intended for multiple patient multiple
407 use that can become contaminated with body fluids or by contaminants carried by expired gases
408 during normal condition or single fault condition shall be so constructed to allow for:
409 1) cleaning and disinfection or
410 2) cleaning and sterilization.
411 c) These processing instructions for the gas pathways that can become contaminated shall:
412 1) conform with ISO 17664-1:2021; or
413 2) ISO 14937:2009, as appropriate; and
414 d) These processing instructions for the gas pathways shall be disclosed in the accompanying
415 information.
416 e) The non-gas pathways of masks and any accessories and their parts intended for multiple patient
417 multiple use shall be so constructed that allow for surface cleaning and disinfection.
418 1) These processing instructions shall:
419 i) conform with ISO 17664-2:2021; and
420 ii) be disclosed in the accompanying information.
421 f) Processing methods for a mask and any accessories and their parts shall maintain their specifications
422 following multiple processing cycles that represents their expected lifetime.
423 g) Check conformity by inspection of accompanying information and review of the validation of the
424 processing methods.
oSIST prEN ISO 17510:2025
ISO 17510
425 1) When conformity with this document could be affected by the processing of the masks and any
426 accessories and their parts, perform the processing for the number of cycles determined by the
427 expected lifetime in accordance with the methods indicated in the accompany document,
428 including any cooling or drying period.
429 2) After these procedures, confirm that the mask and any accessories and their parts conform with
430 their specifications.
431 3) Confirm that the manufacturer has evaluated the effects of multiple processing cycles and the
432 effectiveness of those cycles.
433 5.5 Breathing during single fault condition
434 NOTE 1 There is guidance or rationale for this subclause contained in Clause A.2.
435 a) For masks that cover the mouth, means shall be provided to limit inspiratory and expiratory pressure
436 drop in single fault condition.
437 1) The pressure drop to flow shall not exceed 10 hPa (10 cmH O) (measured at the patient-
438 connection port) at a flowrate of 50 l/min.
439 b) If an anti-asphyxia valve is provided, the open-to-atmosphere pressure shall be less than the
440 minimum rated pressure of the mask.
441 1) The open-to-atmosphere and closed-to-atmosphere pressures shall be disclosed in the
442 accompanying information.
443 NOTE 2 Patients can open their mouth and breathe normally under single fault condition for a mask that only
444 covers the nose.
445 c) Check conformity by inspection of accompanying information and using the tests described in Annex D
446 and Annex E.
447 5.6 Breathing system filter
448 a) breathing system filter shall comply with:
449 1) ISO 23328-1:2003; and
450 2) ISO 23328-2:2002.
451 b) Check conformity by application of the requirements of ISO 23328-1:2003 and ISO 23328-2:2002.
452 6 Audible acoustic energy
453 a) The A-weighted sound power level caused by the mask and any accessories shall be:
454 1) measured in accordance with ISO 4871:1996 and ISO 3744:2010 using engineering-method grade
455 2; and
456 2) disclosed in the accompanying information.
457 b) The A-weighted sound pressure level shall be:
10 © ISO 2024 – All rights reserved

oSIST prEN ISO 17510:2025
ISO 17510
458 1) calculated in accordance with 8.2.5 and 8.6 of ISO 3744:2010; and
459 2) disclosed in the accompanying information.
460 NOTE Care is required in the test setup to ensure that the sound measurement of the mask and any accessories
461 is not interfered with by the noise emitted by the breathing tube or the equipment.
462 c) Check conformity by inspection of accompanying information and the tests in Annex G.
463 7 Measurement uncertainty
464 NOTE There is guidance or rationale for this subclause contained in Clause AA.2
465 a) For the purposes of this document, acceptance criteria for declared tolerances of testing shall use:
466 1) evaluation of uncertainty of measurement from IEC Guide 115:2023, 4.1.1 and 4.1.2; and
467 2) simple acceptance method from IEC Guide 115:2023, 4.3.
468 b) Test equipment and methods shall be selected and controlled to ensure that the measurement
469 uncertainty (with coverage factor k = 2, for confidence of ~ 95%) is no more than 30% of the
470 disclosed tolerance for the parameter being tested.
471 c) The manufacturer shall disclose the measurement uncertainty of each disclosed tolerance in the
472 accompanying information.
473 d) Check conformity by inspection of the accompanying information.
oSIST prEN ISO 17510:2025
ISO 17510
475 Annex A
476 (informative)
478 Particular guidance and rationale
479 A.1 General guidance
480 This Annex provides rationale for some requirements of this document and is intended for those who are
481 familiar with the subject of this document but who have not participated in its development. An
482 understanding of the rationales underlying these requirements is considered to be essential for their
483 proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale
484 will facilitate any revision of this document necessitated by those developments.
485 Figure A.1 is a typical example of a series of component arrangements of ISO 80601-2-70 and ISO 17510.
486 It is intended to enhance comprehe
...