SIST EN ISO 23368:2022

Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)

This device-specific standard specifies requirements for nasal cannulae used in both home-care and hospital environments for the administration of oxygen therapy.

Anästhesie- und Beatmungsgeräte - Nasenbrillen für die Atemtherapie (ISO 23368:2022)

Dieses Dokument legt Anforderungen an Nasenbrillen fest, die sowohl in der häuslichen Pflege als auch in Krankenhausumgebungen für die Sauerstofftherapie verwendet werden.
Dieses Dokument enthält keine Anforderungen zur Verhinderung der Ausbreitung von Feuer in den Schläuchen, definiert jedoch ein vom Benutzer lösbares Verbindungsstück, das zum Einbau einer feueraktivierten Sauerstofffluss-Stoppvorrichtung verwendet werden kann.

Matériel d'anesthésie et d'assistance respiratoire - Canules nasales à faible débit pour oxygénothérapie (ISO 23368:2022)

Le présent document spécifie les exigences applicables aux canules nasales à faible débit utilisées dans les environnements de soins à domicile et dans les environnements hospitaliers pour l’oxygénothérapie.
Le présent document n’inclut pas d’exigences de prévention de la propagation de l’incendie dans la tubulure mais spécifie un raccordement détachable par l’utilisateur qui peut être utilisé pour fixer un dispositif de coupure de l’oxygène activé par un incendie.

Anestezijska in dihalna oprema - Nosni kateter za kisikovo terapijo (ISO 23368:2022)

Ta standard za naprave določa zahteve za nosni kateter, ki se uporablja za izvajanje kisikove terapije pri oskrbi na domu in v bolnišnicah.

General Information

• Status: Published
• Public Enquiry End Date: 08-Sep-2019
• Publication Date: 10-Oct-2022
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Oct-2022
• Due Date: 09-Dec-2022
• Completion Date: 11-Oct-2022
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 23368:2022 - Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 23368:2022
01-november-2022
Anestezijska in dihalna oprema - Nosni kateter za kisikovo terapijo (ISO
23368:2022)
Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy
(ISO 23368:2022)
Anästhesie- und Beatmungsgeräte - Nasenbrillen für die Atemtherapie (ISO 23368:2022)
Matériel d'anesthésie et d'assistance respiratoire - Canules nasales à faible débit pour
oxygénothérapie (ISO 23368:2022)
Ta slovenski standard je istoveten z: EN ISO 23368:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 23368:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23368:2022

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SIST EN ISO 23368:2022


EN ISO 23368
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2022
EUROPÄISCHE NORM
ICS 11.040.10
English Version

Anaesthetic and respiratory equipment - Low-flow nasal
cannulae for oxygen therapy (ISO 23368:2022)
Matériel d'anesthésie et d'assistance respiratoire - Anästhesie- und Beatmungsgeräte - Nasenbrillen für
Canules nasales à faible débit pour oxygénothérapie die Atemtherapie (ISO 23368:2022)
(ISO 23368:2022)
This European Standard was approved by CEN on 9 July 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23368:2022 E
worldwide for CEN national Members.

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SIST EN ISO 23368:2022
EN ISO 23368:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 23368:2022
EN ISO 23368:2022 (E)
European foreword
This document (EN ISO 23368:2022) 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 February 2023, and conflicting national standards
shall be withdrawn at the latest by February 2023.
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.
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 23368:2022 has been approved by CEN as EN ISO 23368:2022 without any modification.


3

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SIST EN ISO 23368:2022

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SIST EN ISO 23368:2022
INTERNATIONAL ISO
STANDARD 23368
First edition
2022-07
Anaesthetic and respiratory
equipment — Low-flow nasal cannulae
for oxygen therapy
Matériel d'anesthésie et d'assistance respiratoire — Canules nasales à
faible débit pour oxygénothérapie
Reference number
ISO 23368:2022(E)
© ISO 2022

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SIST EN ISO 23368:2022
ISO 23368:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2022 – All rights reserved

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SIST EN ISO 23368:2022
ISO 23368:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3  Terms and definitions . 1
4  General requirements . 2
5  Materials . 2
5.1 General . 2
5.2 Biological safety of gas pathways . 2
6 Design requirements .2
6.1 General . 2
6.2 Resistance to flow . . 4
6.3 Inlet connectors . 5
6.4 Nasal prongs . 6
7  Sterility . 7
8 Packaging. 7
9  Information supplied by the manufacturer . 7
Annex A (normative) Test method for resistance to flow . 8
Annex B (normative) Test methods for security of connectors and nasal prongs .9
iii
© ISO 2022 – All rights reserved

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SIST EN ISO 23368:2022
ISO 23368:2022(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 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 by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Airways and related equipment, 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).
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 2022 – All rights reserved

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SIST EN ISO 23368:2022
ISO 2
...

SLOVENSKI STANDARD
oSIST prEN ISO 23368:2019
01-september-2019
Anestezijska in dihalna oprema - Nosni kateter za kisikovo terapijo (ISO/DIS
23368:2019)
Anaesthetic and respiratory equipment - Low flow nasal cannulae for oxygen therapy
(ISO/DIS 23368:2019)
Anästhesie- und Beatmungsgeräte - Nasenbrillen für die Atemtherapie (ISO/DIS
23368:2019)
Matériel d'anesthésie et de réanimation respiratoire - Canules nasales à faible débit pour
oxygénothérapie (ISO/DIS 23368:2019)
Ta slovenski standard je istoveten z: prEN ISO 23368
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 23368:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 23368:2019

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oSIST prEN ISO 23368:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23368
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-05-23 2019-08-15
Anaesthetic and respiratory equipment — Low flow nasal
cannulae for oxygen therapy
Matériel d'anesthésie et de réanimation respiratoire — Canule nasale pour thérapie oxygène
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23368:2019(E)
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. ISO 2019

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oSIST prEN ISO 23368:2019
ISO/DIS 23368
ISO/DIS 23368:2019(E)

Contents
Foreword . iv
Introduction. v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Materials . 2
6 Design requirements . 2
6.1 General . 2
6.2 Resistance to flow . 4
6.3 Inlet connectors . 4
6.4 Nasal prongs . 4
6.5 Colour coding . Error! Bookmark not defined.
7 Sterility . 5
8 Packaging . 5
9 Information supplied by the manufacturer . 5
Annex A (informative) Rationale . 6
Annex B (Normative) Test method for resistance to flow . 7
Annex C (Normative) Test methods for security of connectors and nasal prongs . 8
Bibliography . 9


COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
© ISO #### – All rights reserved iii

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oSIST prEN ISO 23368:2019
ISO/DIS 23368:2019(E)
Contents
Foreword . iv
Introduction. v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Materials . 2
6 Design requirements . 2
6.1 General . 2
6.2 Resistance to flow . 4
6.3 Inlet connectors . 4
6.4 Nasal prongs . 4
6.5 Colour coding . Error! Bookmark not defined.
7 Sterility . 5
8 Packaging . 5
9 Information supplied by the manufacturer . 5
Annex A (informative) Rationale . 6
Annex B (Normative) Test method for resistance to flow . 7
Annex C (Normative) Test methods for security of connectors and nasal prongs . 8
Bibliography . 9
© ISO 2019 – All rights reserved

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oSIST prEN ISO 23368:2019
ISO/DIS 23368:2019(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 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 the following URL:
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee 121, Anaesthetic and respiratory equipment
Subcommittee SC 2, Airways and related equipment and is based on the General Standard for airways and
related devices ISO 18190:2016.
This is the first edition.
Throughout 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: smaller type.
The normative text of tables is also in smaller type;
 terms defined in clause 3: green italics.
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 and National Committees 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 or IEC 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 be adopted for implementation nationally not earlier
than 3 years from the date of publication for equipment newly designed and not earlier than 5 years
from the date of publication for equipment already in production.
© ISO 2019 – All rights reserved

...