SIST EN ISO 5361:2023

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

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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.

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SIST EN ISO 5361:2023

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SIST EN ISO 5361:2023
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 2023

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SIST EN ISO 5361:2023
ISO 5361:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 5361:2023
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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SIST EN ISO 5361:2023
ISO 5361:2023(E)
Bibliography . 44
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SIST EN ISO 5361:2023
ISO 5361:2023(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).
This fourth edition cancels and replaces the third edition (ISO 5361:2016), which has been technically
revised.
The main changes are as follows:
— alignment with the general standard for airway devices ISO 18190;
— to provide additional requirements and design guidance for tracheal tubes designed for use in
paediatric and neonatal patients;
— to clarify the requirements for speciality tracheal tubes such as preformed tracheal tubes;
— updating of references.
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.
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SIST EN ISO 5361:2023
ISO 5361:2023(E)
Introduction
This document provides the essential performance and safety requirements of tracheal tubes and
tracheal tube connectors. Tracheal tubes are intended to be inserted orally or nasally through the larynx
into the trachea to convey gases and vapours to and from a patient’s lungs during spontaneous, assisted
or controlled ventilation for short or prolonged durations.
In addition, tracheal tubes with cuffs are intended to seal and protect the trachea from aspiration.
A variety of cuff designs are available to meet particular clinical requirements. Cuff performance
requirements with associated test methods remain unchanged from the second edition.
Requirements for paediatric tracheal tubes, with and without cuffs, have been updated from the third
edition to include new guidance on the design of tracheal tubes used in paediatric and neonatal patients.
The maximum distance from the patient end of the tracheal tube to the machine end of the inflatable
length of the cuff has been revised in this edition to minimise the risk of the inflatable length of the cuff
aligning with the larynx of neonatal and paediatric patients.
Clinical considerations have also dictated the historical maximum distance from the patient end of the
tracheal tube to the machine end of the inflatable length of the cuff be maintained for tracheal tubes
designed for the general population. Anatomical abnormalities or disease states can require smaller
tracheal tube sizes to be used in adult patients than would typically be appropriate. Because long
tracheal tubes, sometimes of relatively narrow diameter, can be required, tracheal tubes designed to the
historical specification should be readily available.
Tracheal tubes are intended to conform as closely as possible to human anatomy when in position.
Kink resistance requirements with associated test methods to measure the ability of the shaft of the
tracheal tube to resist collapse and avoid increased breathing resistance when bent or curved remain
unchanged from the second edition.
Radiopacity requirements and test methods to characterize the visibility of tracheal tubes in X-rays
used to determine proper placement of the tube remain unchanged from the second edition.
Where applicable a rationale for some of the requirements in this document are included in Annex A
The requirements of this document were developed using the hazard identification for risk assessment
in Annex G.
Throughout this document the following print types are used:
— Requirements and definitions: roman type;
— Informative material appearing outside of tables, such as Notes, examples and references: smaller
type. The normative text of tables is also in smaller type;
— terms defined in Clause 3: italics.
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SIST EN ISO 5361:2023
INTERNATIONAL STANDARD ISO 5361:2023(E)
Anaesthetic and respiratory equipment — Tracheal tubes
and connectors
1 Scope
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562 (all parts), Biocompatibility evaluation of breathing gas pathways in healthcare applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
ASTM F640-20, Standard test methods for determining radiopacity for medical use
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 14971, ISO 18190
and the following apply:
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
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SIST EN ISO 5361:2023
ISO 5361:2023(E)
3.1
Cole-type tracheal tube
tracheal tube combining a short laryngo-tracheal portion (3.5) of small diameter and a longer oral
portion (3.9) of larger diameter with transition from one to the other resulting in a shoulder (3.12)
Note 1 to entry: See Figure 2.
3.2
cut line
point where a tracheal tube can be reduced to its minimum length
Note 1 to entry: The cut line on a cuffed tracheal tube is adjacent to the inflating tube separation point and
towards the machine end.
3.3
glottic depth mark
indicator on the tracheal tube to assist in determining the tip insertion depth beyond the vocal cords
(VC)
3.4
inflation lumen
lumen within the wall of the tracheal tube for inflating the cuff
3.5
laryngo-tracheal portion
portion of a Cole-type tracheal tube (3.1) of small diameter and extending from the bevel tip to the point
at which there is an increase in the outside diameter
3.6
machine end of the tracheal tube connector
portion of the tracheal tube connector intended to mate with an anaesthetic breathing system (ABS) or
ventilator breathing system (VBS)
3.7
Magill-type tracheal tube
subset of curved tracheal tubes with a particular radius (6.7.2) and having a particular bevel at the
patient end
Note 1 to entry: See Figure 5.
3.8
Murphy eye
hole through the wall of a tracheal tube near the patient end and on the side opposite to the bevel
Note 1 to entry: See Figure 7.
3.9
oral portion
portion of a Cole-type tracheal tube (3.1) of a larger diameter extending from the machine end to the
point at which there is a decrease in the outside diameter
3.10
patient end of the connector
end of the tracheal tube connector intended to be inserted into the tracheal tube
3.11
preformed tracheal tube
subset of curved tracheal tubes with an acute radius of curvature intended to direct the machine end of
the tracheal tube in a specific direction
Note 1 to entry: See Annex A.3 for rationale.
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SIST EN ISO 5361:2023
ISO 5361:2023(E)
3.12
shoulder
portion of a Cole-type tracheal tube (3.1) at which transition from the oral portion (3.9) to the laryngo-
tracheal portion (3.5) occurs
3.13
subglottic suction port
opening in the tracheal tube, proximal to the machine end of the inflatable portion of the cuff intended
for the suctioning of secretions
4 General requirements
NOTE There is guidance or rationale for this clause contained in Annex A.4.
4.1 General
The requirements of ISO 18190:2016, Clause 4 shall apply.
Check conformance by inspection of the risk management file.
4.2 Safety
The manufacturer may use type tests different from those detailed within this document, if an
equivalent degree of safety is obtained. Alternative test methods shall be validated against the test
methods specified in this document.
5 Materials
NOTE There is guidance or rationale for this clause contained in Annex A.5.
5.1 General
The applicable requirements of ISO 18190:2016, Clause 5 shall apply.
5.2 Biological safety testing
NOTE There is guidance or rationale for this subclause contained in Annex A.6.
Material used to manufacture tracheal tubes connectors shall be tested and evaluated for biocompatibility
of the breathing gas pathways as specified in the ISO 18562 series as appropriate.
Check conformance by inspection of the technical file.
5.3 Reuse requirements
Tracheal tubes and tracheal tube connectors marked for reuse shall be resistant to deterioration by
the methods of cleaning, disinfection, and sterilization recommended by the manufacturer. The
recommended method or methods of sterilization shall not produce material changes which will
compromise the biological safety.
5.4 Flexibility
Tracheal tubes constructed from materials and at dimensions which enhance flexibility for the purpose
of minimizing tracheal trauma, the risks associated with the flexibility of the tube and implication on
the user’s ability to insert the tracheal tube through the larynx into the trachea shall be assessed and
documented.
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SIST EN ISO 5361:2023
ISO 5361:2023(E)
Check conformance by inspection of the risk management file.
6 Design requirements
6.1 General
The applicable requirements of ISO 18190:2016, Clause 6 shall apply.
6.2 Size designation
The size of tracheal tubes and tracheal tube connectors shall be designated in accordance with Table 1
for tracheal tubes, Table 2 for Cole-type tracheal tubes, and Table 3 for tracheal tube connectors.
6.3 Dimensions
6.3.1 Tracheal tubes
6.3.1.1 The basic dimensions of tracheal tubes shall be in accordance with Table 1.
NOTE There is guidance or rationale for Table 1 contained in Annex A.7.
6.3.1.2 The basic dimensions of Cole-type tracheal tubes shall be in accordance with Table 2.
6.3.1.3 The designated size of the tracheal tube shall be subject to a tolerance of ±0,15 mm for the
actual inside dimeter for sizes 6,0 and smaller, and subject to a tolerance of ±0,20 mm for sizes 6,5 and
larger. The lumen of the tracheal tube should be essentially circular in a plane at right angles to the
long axis. The maximum circular instrument diameter that can pass through the tracheal tube shall be
disclosed to the user [see 9.5 j)].
6.3.1.4 For tracheal tubes, the marked outside diameter (OD) shall be the actual outside diameter
(OD) subject to a tolerance of ±0,15 mm for sizes 6,0 and smaller, or subject to a tolerance of ±0,20 mm
for sizes 6,5 and larger (excluding any protuberance caused by a suction line, cuff, etc., if provided).
For Cole-type tracheal tubes, the market outside diameter shall be the actual outside diameter of the
laryngo-tracheal portion (OD).
6.3.1.5 For Cole-type tracheal tubes, the axial length of the outside surface of the shoulder region,
S - S (see Figure 2), shall not exceed 4 mm for sizes up to and including size 3.
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