Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information

Sondes trachéales destinées aux opérations au laser — Exigences relatives au marquage et aux informations d'accompagnement

General Information

Status
Withdrawn
Publication Date
01-Jul-1998
Withdrawal Date
01-Jul-1998
Current Stage
9599 - Withdrawal of International Standard
Start Date
10-Jun-2005
Completion Date
10-Jun-2005
Ref Project

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ISO 14408:1998 - Tracheal tubes designed for laser surgery -- Requirements for marking and accompanying information
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INTERNATIONAL ISO
STANDARD 14408
First edition
1998-07-01
Tracheal tubes designed for laser
surgery — Requirements for marking and
accompanying information
Sondes trachéales destinées aux opérations au laser — Exigences
relatives au marquage et aux informations d'accompagnement
Reference number
ISO 14408:1998(E)
---------------------- Page: 1 ----------------------
ISO 14408:1998(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.
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.
International Standard ISO 14408 was prepared by Technical Committee
ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2,
Tracheal tubes and other equipment.
Annex A of this International Standard is for information only.
© ISO 1998

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced

or utilized in any form or by any means, electronic or mechanical, including photocopying and

microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
---------------------- Page: 2 ----------------------
ISO ISO 14408:1998(E)
Introduction
This International Standard is intended to provide a standard format for
marking of tracheal tubes which are designed for laser surgery and which
have been tested for laser resistance in accordance with ISO 11990. It is
intended that by limiting the requirements to the disclosure of information
relevant to safety and performance where appropriate, determined in
accordance with standard test methods, a manufacturer will not be limited
in his choice of design and materials.
iii
---------------------- Page: 3 ----------------------
INTERNATIONAL STANDARD ISO ISO 14408:1998(E)
Tracheal tubes designed for laser surgery — Requirements for
marking and accompanying information
1 Scope

This International Standard specifies marking requirements and requirements for information to be supplied by the

manufacturer of cuffed and uncuffed tracheal tubes and related materials designed for laser resistance.

2 Normative reference

The following standard contains provisions, which, through reference in this text, constitute provisions of this

International Standard. At the time of publication, the edition indicated was valid. All standards are subject to

revision, and parties to agreements based on this International Standard are encouraged to investigate the

possibility of applying the most recent edition of the standard indicated below. Members of ISO and IEC maintain

registers of currently valid European and International Standards.

ISO 11990: – , Optics and optical instruments — Lasers and laser-related equipment — Determination of laser

resistance of tracheal tube shafts.
3 Definitions

For the purposes of this International Standard, the following definitions apply.

3.1 tracheal tube

tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the trachea

[ISO 4135:1995]
3.2 cuff

inflatable balloon permanently attached around the tracheal tube near the patient end to provide an effective seal

between the tube and the trachea
3.3 laser-resistant tracheal tube

tracheal tube specifically designated by the manufacturer for use during laser surgery

3.4 laser-resistant tracheal tube treatment

covering and/or surface treatment that adapts or modifies non-laser-resistant tracheal tubes for use in laser surgery

3.5 upper anatomical airway; upper airway
airway above the laryngotracheal junction
3.6 laser-resistant portion

that portion of the tracheal tube intended by the manufacturer to be laser-resistant

4 Marking and labelling

NOTE Marking of tracheal tubes, connectors, packages, inserts and information to be supplied by the manufacturer should

comply with EN 1041.
To be published.
---------------------- Page: 4 ----------------------
ISO
ISO 14408:1998(E)
4.1 Use of symbols

The requirements given in 4.2, 4.3 and 4.4 may be met by the use of the appropriate symbols in accordance with

ISO 7000 or EN 980.
4.2 Marking of tracheal tubes

4.2.1 The following shall be permanently marked on or affixed to any component of the tracheal tube:

a) the name and/or trademark of the manufacturer or supplier;

b) the nominal inside diameter designated by the manufacturer for the tracheal tube;

c) model identification, if necessary to distinguish between similar products from the same manufacturer;

d) for cuffed tracheal tubes, a reference to any preparation designated by the manufacturer as essential for

protection of the cuff from ignition (e.g. "inflate cuff with saline or water before use").

4.2.2 Additional marks may be provided (optional) to assist in positioning the tracheal tube within the trachea. If the

marks are applied to a laser-resistant area of the tube, the test to determine laser resistance values required for the

graph in 5.4 shall be carried out directly upon these markings.
4.2.3 Any component of a la
...

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