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Withdrawn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
Current Stage
9599 - Withdrawal of International Standard
Start Date
05-Nov-2008
Completion Date
05-Nov-2008
Ref Project

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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
---------------------- Page: 1 ----------------------
ISO/TS 16628:2003(E)
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ii © ISO 2003 — All rights reserved
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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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