SIST EN ISO 5367:2023
(Main)Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2023)
Dieses Dokument legt die Mindestanforderungen für Atemsets und Atemschläuche fest, die zur Verwendung mit Anästhesie Atemsystemen, Atemsystemen des Beatmungsgerätes, Anfeuchtern oder Verneblern vorgesehen sind. Es ist anwendbar für Atemsets und Atemschläuche und Adapter am Patientenende, die zusammengebaut geliefert werden, und für solche, die als Bauteile geliefert und nach Anleitung des Herstellers zusammengebaut werden.
Dieses Dokument ist anwendbar für Atemsets, die spezielle Bauteile (z. B. Wasserabscheider) zwischen dem Patientenende und dem Maschinenende enthalten.
Es sind koaxiale und verwandte bifurkierte, doppellumige oder mehrlumige Atemsets und Atemschläuche vorgesehen, die zur Verwendung mit Adaptern am Patientenende geeignet sind.
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et raccords (ISO 5367:2023)
Le présent document spécifie les exigences de base concernant les ensembles respiratoires et les tubes respiratoires destinés à être utilisés avec des systèmes d’anesthésie par voie respiratoire, des systèmes respiratoires de ventilateurs, des humidificateurs ou des nébuliseurs. Il s’applique aux ensembles respiratoires, aux tubes respiratoires et aux adaptateurs d’extrémité «patient» fournis déjà assemblés ainsi qu’à ceux qui sont fournis en tant que composants et assemblés conformément aux instructions du fabricant.
Le présent document s’applique aux ensembles respiratoires qui incluent des composants spéciaux (par exemple, pièges à eau) entre l’extrémité «patient» et l’extrémité «appareil».
Des dispositions ont été prises pour les ensembles respiratoires et les tubes respiratoires coaxiaux, à double branche, à double ou multiples lumières, destinés à être utilisés avec des adaptateurs d’extrémité «patient».
Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO 5367:2023)
Ta dokument določa minimalne zahteve za dihalne sete in cevke za dihanje, namenjene uporabi s sistemi za vdihavanje anestetika, ventilatorskimi dihalnimi sistemi, vlažilniki ali nebulatorji. Uporablja se za dihalne sete in cevke za dihanje ter priključke za pacienta, ki se dobavijo že sestavljeni, in za tiste, ki se dobavijo kot komponente ter se sestavijo v skladu z navodili proizvajalca.
Ta dokument se uporablja za dihalne sete, ki vključujejo posebne komponente (npr. sifone) med pacientom in aparatom.
Predpisi so pripravljeni za koaksialne in povezane razcepljene, dvolumenske ali večlumenske dihalne sete in cevke za dihanje za uporabo s priključki za paciente.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2023
Nadomešča:
SIST EN ISO 5367:2015
Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO 5367:2023)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2023)
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et
raccords (ISO 5367:2023)
Ta slovenski standard je istoveten z: EN ISO 5367:2023
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 5367
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5367:2014
English Version
Anaesthetic and respiratory equipment - Breathing sets
and connectors (ISO 5367:2023)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Atemsets und
Ensembles respiratoires et raccords (ISO 5367:2023) Verbindungsstücke (ISO 5367:2023)
This European Standard was approved by CEN on 3 March 2023.
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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5367:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5367:2023) 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
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 5367:2014.
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 5367:2023 has been approved by CEN as EN ISO 5367:2023 without any modification.
INTERNATIONAL ISO
STANDARD 5367
Sixth edition
2023-07
Anaesthetic and respiratory
equipment — Breathing sets and
connectors
Matériel d'anesthésie et de réanimation respiratoire — Ensembles
respiratoires et raccords
Reference number
ISO 5367:2023(E)
ISO 5367:2023(E)
© ISO 2023
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
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Phone: +41 22 749 01 11
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Published in Switzerland
ii
ISO 5367:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General . 2
4.2 Recommended service life . 2
5 Materials . 2
5.1 General . 2
5.2 Biological safety testing . 2
6 Design requirements .2
6.1 General . 2
6.2 Designated length . 2
6.3 Breathing tube ends . 3
6.4 Leakage . 4
6.5 Resistance to flow . . 4
6.6 Compliance . 5
6.7 Axial strength of breathing tubes . 6
7 Requirements for breathing sets and breathing tubes supplied sterile .6
8 Packaging. 6
9 Information supplied by the manufacturer . 6
9.1 General . 6
9.2 Marking on the packaging . 7
9.3 Instructions for use . 7
Annex A (informative) Rationale . 9
Annex B (informative) Hazard identification for risk management .14
Annex C (normative) Test for security of attachment of plain end to conical connector .15
Annex D (normative) Test for security of attachment of assembled ends and axial strength
of breathing tubes .16
Annex E (normative) Test for leakage .18
Annex F (normative) Measurement of resistance to flow .20
Annex G (normative) Test for increase in flow resistance with bending .23
Annex H (normative) Test for compliance .25
Bibliography .27
iii
ISO 5367:2023(E)
Foreword
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