SIST EN ISO 5361:2023
(Main)Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023)
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)
Dieses Dokument enthält die grundlegenden Leistungs- und Sicherheitsanforderungen an Orotracheal- und Nasotrachealtuben und an Verbindungsstücke für Trachealtuben. Trachealtuben mit durch Metall oder Nylon verstärkter Wand, 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 wurden in dieses Dokument aufgenommen, da zahlreiche Spezial-Trachealtuben heutzutage häufig verwendet werden und für alle ähnliche grundlegende Anforderungen entsprechend diesem Dokument gelten.
Tracheobronchialtuben (einschließlich Endobronchialtuben), Tracheostomietuben und supralaryngeale Atemwegsvorrichtungen 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 Die Literaturhinweise [1] bis [4] befassen sich mit Laseranwendung in den Atemwegen.
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords (ISO 5361:2023)
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
Relations
Standards Content (Sample)
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 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
iv
© ISO 2023 – All rights reserved
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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.
2
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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.
1 2
4
© ISO 2023 – All
...
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.
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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)
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© 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 end.19
53 Figure 2 — Straight tracheal tube connector. 20
54 Figure 3 — Example of a curved tracheal tube connector . 21
55 6.4 *Materials.21
56 6.5 Tracheal tube bevel .21
57 6.6 *Tracheal tube cuffs .22
58 Compliance is checked by inspection. Error! Bookmark not defined.
59 6.7 Inflating system for cuffs.22
60 6.8 Curvature of the tube .23
61 Figure 4 — Typical uncuffed Magill-type tracheal tube. 24
COPYRIGHT PROTECTED DOCUMENT
62 Figure 5 — Typical tracheal tube with straight patient end . 25
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may 63 6.9 *Radiopaque marker.25
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
64 6.10 *Kink resistance.25
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
65 6.11 Additional requirement for tracheal tubes with a murphy eye .25
below or ISO’s member body in the country of the requester.
66 Figure 6 — Patient end of a tracheal tube showing a murphy eye . 26
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva 67 7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile .26
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
68 8 Packaging for tracheal tubes and tracheal tube connectors supplied sterile. 26
Email: copyright@iso.org
Website: www.iso.org
69 8.1 General .26
Published in Switzerland
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oSIST prEN ISO 5361:2021
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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 end . 19
53 Figure 2 — Straight tracheal tube connector . 20
54 Figure 3 — Example of a curved tracheal tube connector . 21
55 6.4 *Materials . 21
56 6.5 Tracheal tube bevel . 21
57 6.6 *Tracheal tube cuffs . 22
58 Compliance is checked by inspection. Error! Bookmark not defined.
59 6.7 Inflating system for cuffs . 22
60 6.8 Curvature of the tube . 23
61 Figure 4 — Typical uncuffed Magill-type tracheal tube . 24
62 Figure 5 — Typical tracheal tube with straight patient end . 25
63 6.9 *Radiopaque marker . 25
64 6.10 *Kink resistance . 25
65 6.11 Additional requirement for tracheal tubes with a murphy eye . 25
66 Figure 6 — Patient end of a tracheal tube showing a murphy eye . 26
67 7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile . 26
68 8 Packaging for tracheal tubes and tracheal tube connectors supplied sterile . 26
69 8.1 General . 26
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70 9 Information supplied by the manufacturer . 26
71 Marking . 26
72 9.1 26
73 9.2 Marking on the tracheal tube individual pack or any insert . 28
74 9.3 Marking on tracheal tube connectors. 29
75 Annex A (informative) Rationale . 30
76 Annex B (normative) Determination of cuff diameter . 35
77 B.1 Principle . 35
78 B.2 Apparatus . 35
79 B.3 Procedure . 35
80 B.4 Expression of results . 35
81 Annex C (normative) Test method for cuffed tube collapse . 36
82 C.1 Principle . 36
83 C.2 Apparatus . 36
84 Table C.1 — Selection of test inflation pressures . 36
85 C.3 Procedure . 36
86 Figure C.1 —B. Apparatus for tube collapse test . 37
87 C.4 Expression of results . 38
88 Annex D (normative) *Test method for cuff herniation . 39
89 D.1 Principle . 39
90 D.2 Apparatus . 39
91 D.3 Procedure . 39
92 D.4 Expression of results . 39
93 Figure D.1 — Apparatus for cuff herniation test . 40
94 Annex E (informative) Guidance on the design of tracheal tube and connectors . 41
95 Annex F (informative) Hazard identification for risk assessment . 46
96 F.1 Potential hazards associated with the placement, removal, and use of tracheal tubes . 46
97 F.2 Potential device hazards . 47
98 Annex G (normative) *Test method for tracheal seal . 49
99 G.1 Principle . 49
100 G.2 Apparatus . 49
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101 G.3 Procedure . 49
102 G.4 Expression of results . 50
103 Figure G.1 — Tracheal seal test apparatus . 51
104 Annex H (normative) Test method to determine kink resistance . 52
105 H.1 Principle . 52
106 H.2 Apparatus . 52
107 H.2.1 Kink resistance test apparatus . 52
108 Table H.1 — Dimensions of radius of curvature. 52
109 H.3 Procedure . 52
110 H.4 Expression of results . 52
111
112
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113 Foreword
114 ISO (the International Organization for Standardization) is a worldwide federation of national standards
115 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
116 through ISO technical committees. Each member body interested in a subject for which a technical
117 committee has been established has the right to be represented on that committee. International
118 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
119 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
120 electrotechnical standardization.
121 The procedures used to develop this document and those intended for its further maintenance are
122 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
123 different types of ISO documents should be noted. This document was drafted in accordance with the
124 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
125 Attention is drawn to the possibility that some of the elements of this document may be the subject of
126 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
127 patent rights identified during the development of the document will be in the Introduction and/or on
128 the ISO list of patent declarations received (see www.iso.org/patents).
129 Any trade name used in this document is information given for the convenience of users and does not
130 constitute an endorsement.
131 For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers
132
133 to Trade (TBT) see www.iso.org/iso/foreword.html
134 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
135 equipment, Subcommittee SC 2, Airways and related equipment.
136 This fourth edition cancels and replaces the third edition (ISO 5361:2016), which has been technically
137 revised.
138 The main changes compared to the previous edition are as follows:
139 — alignment with the general standard for airway devices ISO 18190, Anaesthetic and respiratory
140 equipment – General requirements for airways and related equipment;
141 — To provide additional requirements and design guidance for tracheal tubes designed for use in
142 paediatric and neonatal care
143 — To clarify the requirements for speciality tracheal tubes such as magill-type tracheal tube and
144 preformed tracheal tubes
145 — updating of references.
146 Any feedback or questions on this document should be directed to the user’s national standards body. A
147 complete listing of these bodies can be found at www.iso.org/members.html.
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176 Introduction
177 This provides the essential performance and safety requirements for the design of tracheal tubes and
178 tracheal tube connectors. Tracheal tubes are intended to be inserted through the larynx into the trachea
179 to provide a patent airway in patients during spontaneous, assisted or controlled ventilation for short or
180 prolonged durations to convey gases and vapours to and from the trachea.
181 In addition, tracheal tubes with cuffs are intended to seal and protect the trachea from aspiration.
182 A variety of cuff designs are available to meet particular clinical requirements. Cuff performance
183 requirements with associated test methods remain unchanged from the second edition.
184 Requirements for paediatric tracheal tubes, with and without cuffs, have been updated from the third
185 edition to include new guidance on the design of tracheal tubes for used in paediatric and neonatal
186 patients. The maximum distance from the patient end of the tracheal tube to the machine end of the
187 inflatable length of the cuff has been revised in this edition to minimise the risk of the inflatable length of
188 the cuff aligning with the larynx of neonatal and paediatric patients.
189 Tracheal tubes are intended to conform as closely as possible to human anatomy when in position.
190 Clinical considerations have also dictated the specified length of tracheal tubes because long tracheal
191 tubes, sometimes of relatively narrow diameter, may be required and, therefore, should be readily
192 available. Provision has therefore been included for pre-cut tracheal tubes.
193 Kink resistance requirements with associated test methods to measure the ability of the shaft of the
194 tracheal tube to resist collapse and avoid increased breathing resistance when bent or curved remain
195 unchanged from the second edition.
196 Radiopacity requirements and test methods to characterize the visibility of tracheal tubes in X-rays used
197 to determine proper placement of the tube remain unchanged from the second edition. The requirements
198 of this International Standard were developed using the hazard identification for risk assessment in
199 Annex F.
200
201 Throughout this document the following print types are used:
202 Requirements and definitions: roman type;
203 Test specifications: italic type;
204 Informative material appearing outside of tables, such as notes, examples and references: smaller type.
205 The normative text of tables is also in smaller type;
206 terms defined in clause 3: italics.
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207 Anaesthetic and respiratory equipment — Tracheal tubes and
208 connectors
209 1 Scope
210 This document provides essential performance and safety requirements for oro-tracheal and naso-
211 tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon,
212 tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning,
213 monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for
214 specialized applications are included in this document, as many specialized tracheal tubes are now
215 commonly used, and all share similar essential requirements as defined in this document.
216 Tracheobronchial (including Endobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are
217 excluded from the scope of this document.
218 Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical
219 equipment are outside the scope of this document.
220 NOTE Bibliography references [1] to [4] deal with laser surgery of the airway.
221 2 Normative references
222 The following documents, in whole or in part, are normatively referenced in this document and are
223 indispensable for its application. For dated references, only the edition cited applies. For undated
224 references, the latest edition of the referenced document (including any amendments) applies.
225 ISO 80369-7, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
226 equipment — Part 1: General requirements
227 ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
228 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
229 ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
230 management process
231 ISO 14971:2019, Medical devices — Application of risk management to medical devices
232 ISO 18190, Anaesthetic and respiratory equipment – General requirements for airway and related
233 equipment
234 ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare application – Part
235 1: Evaluation and testing within a risk management process
236 ASTM F640-12, Standard Test Methods for Determining Radiopacity for Medical Use
237 3 Terms and definitions
238 For the purposes of this document, the terms and definitions given in ISO 4135, ISO 14971, ISO
239 18190:2016 and the following apply:
240 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
241 — ISO Online browsing platform: available at https://www.iso.org/obp
242 — IEC Electropedia: available at http://www.electropedia.org/
243 3.1
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244 angle of bevel
245 acute angle between the plane of the bevel (3.2) and the longitudinal axis of the tracheal tube (3.29) at
246 the patient end (3.16)
247 [SOURCE: ISO 4135:2001, 6.3.5]
248 Note 1 See Figures 1a, 1b, and 4.
249 3.2
250 bevel
251 slanted portion at the patient end (3.16) of a tracheal tube (3.29)
252 [SOURCE: ISO 4135:2001, 6.3.4]
253 Note 1 See Figures 1a, 1b, and 4.
254 3.3
255 cole-type tracheal tube
256 tracheal tube (3.29) combining a short laryngo-tracheal portion (3.8) of small diameter and a longer oral
257 portion (3.14) of larger diameter with transition from one to the other resulting in a shoulder (3.26)
258 Note 1 to entry: See Figure 1c.
259 3.4
260 cuff
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