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 gilt 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 gilt für Atemsets, die spezielle Bauteile (z. B. Wasserabscheider) zwischen dem Patientenende und dem Maschinenende enthalten, die bereits zusammengebaut geliefert werden.
Es sind koaxiale und verwandte bifurkierte, doppellumige oder mehrlumige Atemsets und Atemschläuche vorgesehen, die zur Verwendung mit Adaptern am Patientenende geeignet sind.
ANMERKUNG Beispiele verschiedener Typen von Beatmungsgeräten mit Adapter am Patientenende sind in Anhang A abgebildet.
Dieses Dokument gilt nicht für Atemsets und Atemschläuche für Spezialzwecke.
BEISPIEL 1 Beatmungsgeräte verfügen über spezielle Anforderungen an Compliance, Druck oder Atemfrequenz.
Anforderungen für Atemsystemkomponenten wie Ausatemventile, Abgasventile, einstellbare Druckbegrenzungsventile (APL-Ventile), Wärme- und Feuchtigkeitsaustauscher (HMEs), Atemfilter und Reservoirbeutel werden in diesem Dokument nicht behandelt, können jedoch in ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1 [3], ISO 23328-2 [4], und ISO 5362 [1] gefunden werden. Anforderungen für beheizte Atemschläuche sind in ISO 80601-2-74 [2] zu finden.
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
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5367:2023
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
SIST EN ISO 5367:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5367:2023
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SIST EN ISO 5367:2023
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.
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SIST EN ISO 5367:2023
EN ISO 5367:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 5367:2023
EN ISO 5367:2023 (E)
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.
3
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SIST EN ISO 5367:2023
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SIST EN ISO 5367:2023
INTERNATI
...
SLOVENSKI STANDARD
oSIST prEN ISO 5367:2021
01-julij-2021
Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO/DIS 5367:2021)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO/DIS
5367:2021)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO/DIS
5367:2021)
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et
raccords (ISO/DIS 5367:2021)
Ta slovenski standard je istoveten z: prEN ISO 5367
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5367:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 5367:2021
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oSIST prEN ISO 5367:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5367
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-03-30 2021-06-22
Anaesthetic and respiratory equipment — Breathing sets
and connectors
Matériel d'anesthésie et de réanimation respiratoire — Systèmes respiratoires et raccords
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 5367:2021(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 2021
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oSIST prEN ISO 5367:2021
ISO/DIS 5367:2021(E)
1 © ISO 2017, Published in Switzerland
2 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
3 otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the
4 internet or an intranet, without prior written permission. Permission can be requested from either ISO at the
5 address below or ISO’s member body in the country of the requester.
6 ISO copyright office
7 Ch. de Blandonnet 8 • CP 401
8 CH-1214 Vernier, Geneva, Switzerland
9 Tel. + 41 22 749 01 11
10 Fax + 41 22 749 09 47
11 copyright@iso.org
12 www.iso.org
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 5367:2021
ISO/DIS 5367:2021(E)
13 Contents
14 Foreword . iv
15 Introduction . v
16 1 Scope . 1
17 2 Normative references . 1
18 3 Terms and definitions . 1
19 4 General requirements . 3
20 4.1 General . 3
21 4.2 Test methods . 3
22 4.3 Recommended service life . 3
23 5 Materials .
...
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