ISO/TS 16628:2003

Tracheobronchial tubes — Recommendations for size designation and labelling

ISO/TS 16628:2003 provides recommendations for the 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 Technical Specification.

Sondes trachéo-bronchiques — Recommandations pour la désignation de grandeur et le marquage

General Information

• Status: Withdrawn
• Publication Date: 10-Aug-2003
• Withdrawal Date: 10-Aug-2003
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 2 - Airways and related equipment
• Drafting Committee: ISO/TC 121/SC 2 - Airways and related equipment
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 05-Nov-2008

Relations

• Revised: ISO 16628:2008 - Tracheobronchial tubes — Sizing and marking
• Effective Date: 15-Apr-2008
• Consolidated By: ISO 6892-4:2015 - Metallic materials — Tensile testing — Part 4: Method of test in liquid helium
• Effective Date: 06-Jun-2022

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 16628
First edition
2003-08-01

Tracheobronchial tubes —
Recommendations for size designation
and labelling
Sondes trachéo-bronchiques — Recommandations pour la désignation
de grandeur et le marquage




Reference number
ISO/TS 16628:2003(E)
©
ISO 2003

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ISO/TS 16628:2003(E)
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ISO/TS 16628:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Terms and definitions. 1
3 General requirements. 1
3.1 Size designation of bronchial segment . 1
3.2 Nominal maximum bronchoscope diameter . 1
3.3 Colour coding. 1
3.4 Segment differentiation. 1
4 Marking. 2
4.1 Use of symbols. 2
4.2 Marking of tracheobronchial tubes . 2
4.3 Marking on tracheobronchial tube individual pack and any insert . 3
Annex A (informative) Determination of circumference of bronchial segment of tracheobronchial
tubes. 4
A.1 Principle. 4
A.2 Apparatus. 4
A.3 Procedure. 4
A.4 Expression of results. 4
Annex B (informative) Determination of nominal maximum bronchoscope diameter. 5
B.1 Principle. 5
B.2 Apparatus. 5
B.3 Procedure. 5
B.4 Expression of results. 6
Bibliography . 7

© ISO 2003 — All rights reserved iii

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ISO/TS 16628:2003(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.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of
the parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a
vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
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/TS 16628 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Tracheal tubes and other equipment.
iv © ISO 2003 — All rights reserved

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ISO/TS 16628:2003(E)
Introduction
This Technical Specification is intended to provide recommendations to assist 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. It is designed for either
right or left mainstem bronchus placement, and has both a tracheal and a bronchial cuff.

© ISO 2003 — All rights reserved v

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