ISO 16628:2008
(Main)Tracheobronchial tubes — Sizing and marking
Tracheobronchial tubes — Sizing and marking
ISO 16628:2008 provides requirements for size designation and labelling of tracheobronchial tubes, including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronchial tubes that include bronchus blockers are excluded from the scope of ISO 16628:2008.
Sondes trachéo-bronchiques — Dimensionnement et marquage
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 16628
First edition
2008-11-15
Tracheobronchial tubes — Sizing and
marking
Sondes trachéo-bronchiques — Dimensionnement et marquage
Reference number
ISO 16628:2008(E)
©
ISO 2008
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ISO 16628:2008(E)
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ii © ISO 2008 – All rights reserved
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ISO 16628:2008(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 16628 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Tracheal tubes and other equipment.
This first edition cancels and replaces the Technical Specification ISO/TS 16628:2003.
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ISO 16628:2008(E)
Introduction
Originally a Technical Specification, this document is being revised as an International Standard to provide
requirements for size designation and labelling of tracheobronchial tubes. Such requirements will have the
benefit of enabling clinicians to select the most appropriate device for their patient population and to select
accessories such as fiberoptic bronchoscopes based on the measured internal diameter of the bronchial
segment of the tracheobronchial tube.
This International Standard provides requirements for manufacturers in establishing a standard method of size
designation for tracheobronchial tubes and their parts. A tracheobronchial tube is a double lumen tracheal
tube that facilitates selective ventilation to one or both lungs and allows isolation of one lung from the other. It
is designed for either right or left mainstem bronchus placement, and has both a tracheal and bronchial cuff.
iv © ISO 2008 – All rights reserved
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INTERNATIONAL STANDARD ISO 16628:2008(E)
Tracheobronchial tubes — Sizing and marking
1 Scope
This International Standard provides requirements for size designation and labelling of tracheobronchial tubes,
including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronchial tubes that
include bronchus blockers are excluded from the scope of this International Standard.
2 Normative References
The following referenced documents are indispensable for the application 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 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
EN 1041, Information supplied by the manufacturer with medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
tracheobronchial tube
double-lumen tube designed for insertion into the trachea and a main bronchus to separate the right and left
lungs
4 General requirements
4.1 Outside diameter of bronchial segment
The outside diameter of the bronchial segment of the tube shall be the outside diameter measured at the mid-
point of the deflated bronchial cuff (see Key 9 of Figure 1) in millimetres, determined in accordance with
Annex A.
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ISO 16628:2008(E)
Key
1 machine end of the tracheobronchial tube
2 bronchial segment
3 cross-section of tracheal lumen (not necessarily circular)
4 cross-section of bronchial lumen (not necessarily circular)
5 patient end of the bronchial segment
6 patient end of the tracheal segment
7 tracheal cuff
8 bronchial cuff
9 point of measurement of the outside diameter of the bronchial segment
Figure 1 — Example of a tracheobronchial tube
4.2 Effective inside diameter
The inside diameter of the lumena of the bronchial and tracheal segments of the tube in millimetres shall be
determined in accordance with Annex B.
NOTE The effective inside diameter is intended as a guide to selecting the appropriate diameter bronchoscope or
other device to be inserted into the tracheobronchial tube.
4.3 Colour coding
The bronchial cuff and its associated pilot balloon shall be entirely coloured blue.
4.4 Segment
...
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