Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11)

This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1      There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2      ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.

Anästhesie- und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2023, korrigierte Fassung 2023-11)

Dieses Dokument enthält spezifische Anforderungen an die grundlegende Sicherheit und wesentliche Leistung von Orotrachealtuben und Nasotrachealtuben sowie Verbindungsstücke für Trachealtuben, Trachealtuben mit metall- oder kunststoffverstärkten Wänden, Trachealtuben mit Schultern, konische Trachealtuben, Trachealtuben mit Möglichkeiten zum Absaugen, zum Überwachen oder zur Zufuhr von Medikamenten oder sonstigen Gasen und die zahlreichen anderen Arten von Trachealtuben für Spezialanwendungen.
Tracheobronchialtuben (einschließlich Endobronchialtuben) (siehe ISO 16628), Tracheostomietuben (siehe ISO 5366) und supralaryngeale Atemwegsvorrichtungen (siehe ISO 11712) sind vom Anwendungsbereich dieses Dokuments ausgenommen.
Trachealtuben, die für die Anwendung mit brennbaren Anästhesiegasen oder -mitteln sowie Laser oder elektrochirurgischen Geräten bestimmt sind, sind nicht durch dieses Dokument abgedeckt.
ANMERKUNG 1   Abschnitt A.2 enthält eine Anleitung oder Begründung zu diesem Abschnitt.
ANMERKUNG 2   ISO 11990 1, ISO 11990 2 und ISO 14408 behandeln die Laserchirurgie der Atemwege.

Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords (ISO 5361:2023, Version corrigée 2023-11)

Le présent document fournit des exigences spécifiques pour la sécurité de base et les performances essentielles des sondes orotrachéales et nasotrachéales et des raccords de sonde trachéale, des sondes trachéales à parois renforcées de métal ou de plastique, des sondes trachéales à épaulements, des sondes trachéales coniques, des sondes trachéales avec dispositifs pour aspiration, surveillance ou administration de médicaments ou d’autres gaz ainsi que les nombreux autres types de sondes trachéales conçues pour des applications spécialisées.
Les sondes trachéo-bronchiques (y compris les sondes endobronchiques) (voir ISO 16628), les canules de trachéotomie (voir ISO 5366) et les canules supralaryngées (voir ISO 11712) sont exclues du domaine d’application du présent document.
Les sondes trachéales destinées à être utilisées avec des gaz ou des agents anesthésiques inflammables, des équipements laser ou du matériel électrochirurgical ne relèvent pas du domaine d’application du présent document.
NOTE 1      L’Article A.2 contient des recommandations ou des justifications applicables à cet article.
NOTE 2      L’ISO 11990-1, l’ISO 11990-2 et l’ISO 14408 traitent de la chirurgie laser des voies aériennes.

Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki (ISO 5361:2023)

Ta dokument določa posebne zahteve za osnovno varnost in bistveno učinkovitost ustnih in nosnih sapničnih tubusov in priključkov, sapničnih tubusov s stenami, ojačenimi s kovino ali plastiko, sapničnih tubusov z izboklinami, konusnih sapničnih tubusov, sapničnih tubusov s sredstvi za sesanje, nadzorovanje ali dovajanje zdravil in drugih plinov, in številnih drugih vrst sapničnih tubusov, namenjenih za posebne vrste uporabe.
Trahiobronhialni (vključno z endobronhialnimi) tubusi (glej standard ISO 16628), traheotomični tubusi (glej standard ISO 5366) in supralaringealne zračne poti (glej standard ISO 11712) so izključene iz področja uporabe tega dokumenta.
Sapnični tubusi, ki so namenjeni uporabi z vnetljivimi anestetičnimi plini ali anestetiki, ter laserska ali elektrokirurška oprema ne spadajo na področje uporabe tega dokumenta.
OPOMBA 1:   Za to točko obstajajo smernice ali utemeljitev v dodatku A.2.
OPOMBA 2:      Standardi ISO 11990-1, ISO 11990-2, in ISO 14408 obravnavajo lasersko operacijo dihal.

General Information

Status
Published
Publication Date
31-Jan-2023
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Feb-2023
Completion Date
01-Feb-2023

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SLOVENSKI STANDARD
SIST EN ISO 5361:2023
01-maj-2023
Nadomešča:
SIST EN ISO 5361:2016
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki (ISO
5361:2023)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023)
Anästhesie- und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO
5361:2023)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO 5361:2023)
Ta slovenski standard je istoveten z: EN ISO 5361:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5361:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5361:2023

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SIST EN ISO 5361:2023


EN ISO 5361
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5361:2016
English Version

Anaesthetic and respiratory equipment - Tracheal tubes
and connectors (ISO 5361:2023)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords (ISO 5361:2023) Verbindungsstücke (ISO 5361:2023)
This European Standard was approved by CEN on 9 January 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 5361:2023 E
worldwide for CEN national Members.

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SIST EN ISO 5361:2023
EN ISO 5361:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 5361:2023
EN ISO 5361:2023 (E)
European foreword
This document (EN ISO 5361:2023) 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 August 2023, and conflicting national standards shall
be withdrawn at the latest by August 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.
This document supersedes EN ISO 5361:2016.
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 5361:2023 has been approved by CEN as EN ISO 5361:2023 without any modification.

3

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SIST EN ISO 5361:2023

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SIST EN ISO
...

SLOVENSKI STANDARD
oSIST prEN ISO 5361:2021
01-maj-2021
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki
(ISO/DIS 5361:2021)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO/DIS
5361:2021)
Anästhesie- und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO/DIS
5361:2021)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO/DIS 5361:2021)
Ta slovenski standard je istoveten z: prEN ISO 5361
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5361:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 5361:2021

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oSIST prEN ISO 5361:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5361
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-03-25 2021-06-17
Anaesthetic and respiratory equipment — Tracheal tubes
and connectors
Matériel d'anesthésie et de réanimation respiratoire — Sondes trachéales 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 5361:2021(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 5361:2021
ISO/DIS 5361:2021(E)
© ISO ISO 5361:20XX – All rights reserved

34 Contents
35 Foreword .6
36 Introduction.8
37 1 Scope .9
38 2 Normative references .9
39 3 Terms and definitions.9
40 4 *General requirements . 13
41 4.1 General .13
42 4.2 Safety .13
43 5 Materials. 13
44 5.1 General .13
45 5.2 *Biological safety testing.14
46 6 Design Requirements. 14
47 6.1 General .14
48 6.2 Size designation .14
49 6.3 Dimensions .14
50 Table 1a — *Basic dimensions of tracheal tubes (see Figures 1a and 1b). 15
51 Table 1b — Basic dimensions of Cole-type tracheal tubes (see Figure 1c). 16
52 Table 2 — Tracheal tube connectors — Size range and basic dimensions of patient
...

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