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EN ISO 5361:2023

(Main)

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

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
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Feb-2023
Completion Date
01-Feb-2023
Ref Project
SIST EN ISO 5361:2023 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023)

Relations

Replaces
EN ISO 5361:2016 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Effective Date
19-Dec-2018

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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.

INTERNATIONAL ISO
STANDARD 5361
Fourth edition
2023-01
Anaesthetic and respiratory
equipment — Tracheal tubes and
connectors
Matériel d'anesthésie et de réanimation respiratoire — Sondes
trachéales et raccords
Reference number
ISO 5361:2023(E)
ISO 5361:2023(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
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 5361:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 General . 3
4.2 Safety. 3
5 Materials . 3
5.1 General . 3
5.2 Biological safety testing . 3
5.3 Reuse requirements . 3
5.4 Flexibility. 3
6 Design requirements .4
6.1 General . 4
6.2 Size designation . 4
6.3 Dimensions . 4
6.3.1 Tracheal tubes . 4
6.3.2 Tracheal tube connectors . 8
6.4 Tracheal tube bevel . 10
6.5 Tracheal tube cuffs. 10
6.6 Cuff inflating system . 11
6.7 Tracheal tube curvature .12
6.8 Surface finish .12
6.9 Radiopaque marker . 14
6.10 Kink resistance. 14
6.11 Additional requirements for tracheal tubes with a Murphy eye . 14
7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile .15
8 Packaging for tracheal tubes and tracheal tube connectors supplied sterile .15
9 Information supplied by the manufacturer on the tracheal tube, individual pack or
the instructions for use .15
9.1 General . 15
9.2 Durability of tracheal tube markings. 15
9.3 Marking . 16
9.3.1 Tracheal tubes shall be clearly and legibly marked with: . 16
9.3.2 Marking on tracheal tube connectors . 16
9.4 Placement of marking . 16
9.5 Instructions for use . 17
Annex A (informative) Rationale .19
Annex B (informative) Guidance on the design of tracheal tubes and tracheal tube
connectors .25
Annex C (normative) Determination of cuff diameter .30
Annex D (normative) Test method for cuffed tube collapse .31
Annex E (normative) Test method for cuff herniation .34
Annex F (normative) Test method for tracheal seal .36
Annex G (informative) Hazard identification for risk assessment .39
Annex H (normative) Test method to determine kink resistance .42
...

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—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
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If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
This document does not specify the requirements for:
—    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
—    high-frequency oscillatory ventilators (HFOVs);
—    respiratory high flow equipment, which are given in

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EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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