oSIST prEN ISO 17510:2025

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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)
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
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

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
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 abo
...