prEN ISO 16628

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)

Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO/DIS 16628:2020)

General Information

• Status: Not Published
• 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: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 29-Nov-2021
• Completion Date: 29-Nov-2021
• Ref Project: oSIST prEN ISO 16628:2020 - Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO/DIS 16628:2020)

Standards Content (sample)

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 [e-mail]
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: [phone]
Fax: [phone]
Email: [e-mail]
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 [e-mail]
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

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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.

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.
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oSIST prEN ISO 16628:2020
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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.
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oSIST prEN ISO 16628:2020
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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

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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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