SIST EN ISO 16628:2022
(Main)Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
This document specifies requirements for safety, materials, design and information supplied with
tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is
required.
Tracheal tubes that include bronchus blockers are excluded from the scope of this document.
Anästhesie- und Beatmungsgeräte - Tracheobronchialtuben (ISO 16628:2022)
Dieses Dokument legt Anforderungen bezüglich Sicherheit, Werkstoffe, Konstruktion und Informationen fest, die mit Tracheobronchialtuben geliefert werden. Diese Geräte werden verwendet, wenn die Isolierung der Atemwege eines oder beider Lungenflügel erforderlich ist.
Trachealtuben mit Bronchusblockern sind vom Anwendungsbereich dieses Dokuments ausgeschlossen.
Matériel d’anesthésie et de réanimation respiratoire - Sondes trachéobronchiques (ISO 16628:2022)
Le présent document spécifie les exigences relatives à la sécurité, aux matériaux, à la conception et aux informations fournies avec les sondes trachéobronchiques. Ces dispositifs sont utilisés lorsqu’il est nécessaire d’isoler les voies aériennes d’un poumon ou des deux poumons.
Les sondes trachéales qui incluent des bloqueurs bronchiques sont exclues du domaine d’application du présent document.
Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO 16628:2022)
Ta dokument določa zahteve za varnost, materiale, zasnovo in informacije, ki so priložene traheobronhialnim cevkam. Ti pripomočki se uporabljajo, kadar je treba izolirati dihalne poti enega ali obeh pljučnih
kril.
Trahealne cevke, ki vključujejo bronhialne zaviralce, ne spadajo na področje uporabe tega dokumenta.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16628:2022
01-september-2022
Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO 16628:2022)
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
Anästhesie- und Beatmungsgeräte - Tracheobronchialtuben (ISO 16628:2022)
Matériel d’anesthésie et de réanimation respiratoire - Sondes trachéobronchiques (ISO
16628:2022)
Ta slovenski standard je istoveten z: EN ISO 16628:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 16628:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 16628:2022
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SIST EN ISO 16628:2022
EN ISO 16628
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Tracheobronchial
tubes (ISO 16628:2022)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte -
Sondes trachéobronchiques (ISO 16628:2022) Tracheobronchialtuben (ISO 16628:2022)
This European Standard was approved by CEN on 11 June 2022.
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, Turkey 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16628:2022 E
worldwide for CEN national Members.
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SIST EN ISO 16628:2022
EN ISO 16628:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 16628:2022
EN ISO 16628:2022 (E)
European foreword
This document (EN ISO 16628:2022) 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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16628:2022 has been approved by CEN as EN ISO 16628:2022 without any modification.
3
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SIST EN ISO 16628:2022
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SIST EN ISO 16628:2022
INTERNATIONAL ISO
STANDARD 16628
Second edition
2022-06
Anaesthetic and respiratory
equipment — Tracheobronchial tubes
Matériel d’anesthésie et de réanimation respiratoire — Sondes
trachéobronchiques
Reference number
ISO 16628:2022(E)
© ISO 2022
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SIST EN ISO 16628:2022
ISO 16628:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
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SIST EN ISO 16628:2022
ISO 16628:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General . 2
4.2 Safety. 2
5 Materials . 2
5.1 General . 2
5.2 Biological safety testing . 2
6 Design requirements .3
6.1 General . 3
6.2 Designated size . 3
6.3 Dimensions . 3
6.4 Connectors . 3
6.5 Cuffs . 3
6.6 Cuff inflation system . 4
6.7 Bronchial segment . 4
7 Requirements for tracheobronchial tubes supplied sterile . 5
8 Packaging. 5
9 Information supplied by the manufacturer . 6
9.1 General . 6
9.2 Marking . 6
9.2.1 Durability and legibility . 6
9.2.2 Marking on the tracheobronchial tube . 6
9.3 Colour coding . 7
9.4 Marking on the individual packaging or insert . 7
Annex A (informative) Rationale . 8
Annex B (normative) Test method to determine the outside diameter of the bronchial
segment .10
Annex C (normative) Test method to determine the effective inside diameters .11
Bibliography .13
iii
© ISO 2022 – All rights reserved
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SIST EN ISO 16628:2022
ISO 16628:2022(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 second edition cancels and replaces the first edition (ISO 16628:2008), which has been technically
revised.
The main changes are as follows:
— alignment with the general standard for airway devices, ISO 18190;
— inclusion of requirements in addition to marking and sizing;
— 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.
iv
© ISO 2022 – All rights reserved
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SIST EN ISO 16628:2022
ISO 16628:2022(E)
Introduction
Tracheobronchial tubes are double lumen tracheal tubes that enable isolation of the airways of one lung
from the other. This allows protection of one lung if there is bleeding or a leak in the airways of the
other. They facilitate selective ventilation of each lung. One lumen ends in the trachea, with a tracheal
cuff above the opening. The other lumen is designed to lie either in the right or the left main bronchus
with a cuff sealing that bronchus. The cuff of a right-sided tube is usually shaped to permit ventilation of
the right upper lobe.
The first edition of ISO 16628 only specified requirements for the marking and sizing of tracheobronchial
tubes.
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.
v
© ISO 2022 – All rights reserved
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SIST EN ISO 16628:2022
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SIST EN ISO 16628:2022
INTERNATIONAL STANDARD ISO 16628:2022(E)
Anaesthetic and respiratory equipment —
Tracheobronchial tubes
1 Scope
This document specifies requirements for safety, materials, design and information supplied with
tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is
required.
Tracheal tubes that include bronchus blockers are excluded from the scope of this document
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. 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 5361:2016, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the terms and defi
...
SLOVENSKI STANDARD
oSIST prEN ISO 16628:2020
01-maj-2020
Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO/DIS 16628:2020)
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO/DIS 16628:2020)
Anästhesie- und Beatmungsgeräte - Tracheobronchialtuben (ISO/DIS 16628:2020)
Matériel d’anesthésie et de réanimation respiratoire - Tubes trachéobronchiques
(ISO/DIS 16628:2020)
Ta slovenski standard je istoveten z: prEN ISO 16628
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 16628:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 16628:2020
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oSIST prEN ISO 16628:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16628
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-03-10 2020-06-02
Anaesthetic and respiratory equipment -
Tracheobronchial tubes
Sondes trachéo-bronchiques — Dimensionnement et marquage
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 16628:2020(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 2020
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oSIST prEN ISO 16628:2020
© ISO 16628 – All rights reserved
ISO/DIS 16628:2020(E)
1 © ISO 2017, Published in Switzerland
2 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
3 otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the
4 internet or an intranet, without prior written permission. Permission can be requested from either ISO at the
5 address below or ISO’s member body in the country of the requester.
6 ISO copyright office
7 Ch. de Blandonnet 8 • CP 401
8 CH-1214 Vernier, Geneva, Switzerland
9 Tel. + 41 22 749 01 11
10 Fax + 41 22 749 09 47
11 copyright@iso.org
12 www.iso.org
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
© ISO 16628 – All rights reserved 1
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 16628:2020
ISO/DIS 16628:2020(E)
© ISO 16628 – All rights reserved
1 © ISO 2017, Published in Switzerland
2 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
3 otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the
4 internet or an intranet, without prior written permission. Permission can be requested from either ISO at the
5 address below or ISO’s member body in the country of the requester.
6 ISO copyright office
7 Ch. de Blandonnet 8 • CP 401
8 CH-1214 Vernier, Geneva, Switzerland
9 Tel. + 41 22 749 01 11
10 Fax + 41 22 749 09 47
11 copyright@iso.org
12 www.iso.org
© ISO 16628 – All rights reserved 1
© ISO 2020 – All rights reserved
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oSIST prEN ISO 16628:2020
ISO/DIS 16628:2020(E)
ISO 16628:20XX
13 Contents
14 Foreword . 3
15 Introduction. 4
16 1 Scope . 5
17 2 Normative references . 5
18 3 Terms and definitions . 5
19 4 General requirements . 6
20 4.1 General . 6
21 4.2 Safety . 6
22 5 Materials . 6
23 5.1 General . 6
24 5.2 *Biological safety testing. 6
25 6 Design requirements . 6
26 6.1 General . 6
27 6.2 Connectors . 6
28 6.3 Cuffs . 7
29 6.4 Cuff inflation system . 7
30 7 Requirements for tracheobronchial tubes supplied sterile . 8
31 8 Packaging . 9
32 9 Information supplied by the manufacturer . 9
33 9.1 General . 9
34 9.2 Marking . 9
35 9.3 Colour coding . 10
36 9.4 Marking on the packaging or insert . 10
37 Annex A (informative) Rationale . 12
38 Annex B (normative) Test method to determine the designated size of the tracheobronchial
39 tube and the outside diameter of the bronchial segment . 13
40 Annex C (normative) Test method to determine the effective inside diameters . 15
41 Bibliography . 17
2 © ISO 16628 – All rights reserved
© ISO 2020 – All rights reserved
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oSIST prEN ISO 16628:2020
ISO/DIS 16628:2020(E)
© ISO 16628 – All rights reserved
42 Foreword
43 ISO (the International Organization for Standardization) is a worldwide federation of national standards
44 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
45 through ISO technical committees. Each member body interested in a subject for which a technical
46 committee has been established has the right to be represented on that committee. International
47 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
48 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
49 electrotechnical standardization.
50 The procedures used to develop this document and those intended for its further maintenance are
51 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
52 different types of ISO documents should be noted. This document was drafted in accordance with the
53 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
54 Attention is drawn to the possibility that some of the elements of this document may be the subject of
55 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
56 patent rights identified during the development of the document will be in the Introduction and/or on
57 the ISO list of patent declarations received (see www.iso.org/patents).
58 Any trade name used in this document is information given for the convenience of users and does not
59 constitute an endorsement.
60 For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
61 expressions related to conformity assessment, as well as information about ISO's adherence to the World
62 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
63 www.iso.org/iso/foreword.html.
64 This document was prepared by Technical Committee 121, Anaesthetic and respiratory equipment
65 Subcommittee SC 2, Airways and related equipment.
66
This document is written following the format of ISO 18190 General standard for airways and related
67 equipment. The requirements in this device-specific standard take precedence over any conflicting
68 requirements in the general standard.
69 This second edition cancels and replaces the first edition (ISO 16628:2008), which has been technically
70 revised to include all aspects of tracheobronchial tubes in addition to the sizing and marking.
71 The main changes compared to the previous edition are as follows:
72 — Alignment with the general standard for airway devices ISO 18190;
73 — Inclusion of requirements other than just marking and sizing;
74 — updating of references.
75 Throughout this document the following print types are used:
76 Requirements and definitions: roman type;
77 Test specifications: italic type;
78 Informative material appearing outside of tables, such as notes, examples and references: smaller type.
79 The normative text of tables is also in smaller type;
80 terms defined in clause 3: bold italics.
81 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
82 that there is guidance or rationale related to that item in Annex A.
© ISO 16628 – All rights reserved 3
© ISO 2020 – All rights reserved
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oSIST prEN ISO 16628:2020
ISO/DIS 16628:2020(E)
ISO 16628:20XX
83 Introduction
84 Tracheobronchial tubes are double lumen tracheal tubes that enable isolation of the airways of one
85 lung from the other. This allows protection of one lung if there is bleeding or a leak in the airways of the
86 other. They facilitate selective ventilation of each lung. One lumen ends in the trachea, with a tracheal
87 cuff above the opening. The other lumen is designed to lie either in the right or the left main bronchus
88 with a cuff sealing that bronchus. The cuff of a right-sided tube is usually shaped to permit ventilation
89 of the right upper lobe.
90 The first edition of ISO 16628 only specified requirements for the marking and sizing of
91 tracheobronchial tubes. This second edition includes the marking and sizing requirements as well as
92 requirements for all the other aspects of tracheobronchial tubes.
4 © ISO 16628 – All rights reserved
© ISO 2020 – All rights reserved
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oSIST prEN ISO 16628:2020
ISO/DIS 16628:2020(E)
© ISO 16628 – All rights reserved
93 Anaesthetic and respiratory equipment – Tracheobronchial tubes
94 1 Scope
95 This document specifies requirements for safety, materials, design and information to be supplied with
96 tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is
97 required.
98 Tracheal tubes that include bronchus blockers are excluded from the scope of this document
99 2 Normative references
100 The following documents are referred to in the text in such a way that some or all of their content
101 constitutes requirements of this document. For dated references, only the edition cited applies. For
102 undated references, the latest edition of the referenced document (including any amendments) applies.
103 ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
104 ISO 5356-1:2016, Anaesthetic and respiratory equipment —Conical Cones and sockets
105 ISO 5361:2016, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
106 ISO 18190:2016, Anaesthetic and respiratory equipment – General requirements for airways and related
107 equipment
108 ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
109 Evaluation and testing within a risk management process
110 ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors
111 for intravascular or hypodermic applications
112 3 Terms and definitions
113 For the purposes of this document, the terms and definitions given in ISO 4135, ISO 18190:2016 and the
114 following apply:
115 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
116 — IEC Electropedia: available at http://www.electropedia.org/
117 — ISO Online browsing platform: available at https://www.iso.org/obp
118 3.1
119 cuff
120 inflatable balloon permanently attached around the tracheobronchial tube (3.4) near the patient end of
121 the tracheal segment and patient end of the bronchial segment the used to provide a seal between the
122 tube and the trachea or bronchus
123 Note to entry: See Figure 1.
124 3.2
125 designated size
126 circumference of the tracheobronchial tube (3.4)
127 3.2
128 effective inside diameter
129 The diameter of the maximum size of cylindrical object that will pass through the tube
© ISO 16628 – All rights reserved 5
© ISO 2020 – All rights reserved
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oSIST prEN ISO 16628:2020
ISO/DIS 16628:2020(E)
ISO 16628:20XX
130 3.3
131 tracheal tube
132 Tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from
133 the trachea
134 [SOURCE: ISO 4135:2001, 6.3.1]
135 3.4
136 tracheobronchial tube
137 double-lumen tube designed for insertion into the trachea and a main bronchus to enable isolation of
138 the airways of one lung from the other
139 4 General requirements
140 4.1 General
141 The requirements of ISO 18190:2016, Clause 4 apply.
142 4.2 Safety
143 Manufacturers may use type test different from those detailed within this document, if an equivalent
144 d
...
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