FprEN ISO 5361

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 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 16628), Tracheostomietuben (siehe ISO 5366) und supralaryngeale Atemwegsvorrichtungen (siehe ISO 17712) 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   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)

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/FDIS 5361:2022)

General Information

• Status: Not 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: kSIST FprEN ISO 5361:2022 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO/FDIS 5361:2022)

Relations

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

Standards Content (Sample)

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)
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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© 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: [phone]
Fax: [phone]

68 8 Packaging for tracheal tubes and tracheal tube connectors supplied sterile.......................... 26

Email: [e-mail]
Website: www.iso.org

69 8.1 General .................................................................................................................................................26

Published in Switzerland
ii © ISO 2021 – All rights reserved
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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.
148
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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
...