EN ISO 23368:2022
(Main)Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)
Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)
This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy.
This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.
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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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 23368:2022(E)
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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 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 23368:2022(E)
Introduction
Low-flow nasal cannulae are used to guide oxygen directly to the patient’s nasal passageways via nasal
prongs during the administration of oxygen therapy.
Several countries have introduced a fire-activated oxygen flow-stopping device for use with oxygen
therapy systems especially in the home-care environment that prevents the proliferation of fire along
the tubing if it catches light. It is recommended that these flow-stopping devices be fitted as close to the
patient as possible.
v
INTERNATIONAL STANDARD ISO 23368:2022(E)
Anaesthetic and respiratory equipment — Low-flow nasal
cannulae for oxygen therapy
1 Scope
This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital
environments for the administration of oxygen therapy.
This document does not include requirements to prevent the proliferation of fire within the tubing but
does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment – Vocabulary and semantics
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
1)
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for respiratory applications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 18190 and the
following apply.
ISO and IEC m
...
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