EN ISO 11990:1999

SLOVENSKI STANDARD
SIST EN ISO 11990:2000
01-januar-2000
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Optics and optical instruments - Lasers and laser-related equipment - Determination of
laser resistance of tracheal tube shafts (ISO 11990:1999)
Optik und optische Instrumente - Laser und Laseranlagen - Bestimmung der
Laserresistenz des Schafts von Trachealtuben (ISO 11990:1999)
Optique et instruments d'optique - Lasers et équipements associés aux lasers -
Détermination de la résistance au laser des tubes trachéaux (ISO 11990:1999)
Ta slovenski standard je istoveten z: EN ISO 11990:1999
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
SIST EN ISO 11990:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11990:2000

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SIST EN ISO 11990:2000

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SIST EN ISO 11990:2000

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SIST EN ISO 11990:2000

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SIST EN ISO 11990:2000

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SIST EN ISO 11990:2000
INTERNATIONAL ISO
STANDARD 11990
First edition
1999-07-15
Optics and optical instruments — Lasers
and laser-related equipment —
Determination of laser resistance of
tracheal tube shafts
Optique et instruments d'optique — Lasers et équipements associés aux
lasers — Détermination de la résistance au laser des tubes trachéaux
A
Reference number
ISO 11990:1999(E)

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SIST EN ISO 11990:2000
ISO 11990:1999(E)
Contents
1 Scope .1
2 Normative reference .1
3 Terms and definitions .1
4 Principle.2
5 Significance and use of the test.2
6 Apparatus .3
7 Reagents and materials.5
8 Preparation of test units .6
9 Preparation of apparatus .6
10 Test procedure.6
11 Interpretation of results .7
12 Test report .8
Bibliography.9
©  ISO 1999
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 iso@iso.ch
Printed in Switzerland
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SIST EN ISO 11990:2000
© ISO
ISO 11990:1999(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 3.
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 11990 was prepared by ISO/TC 172, Optics and Optical Instruments, Subcommittee
SC 9, Electrooptical systems.
This International Standard is based on ASTM F29.01.10.
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SIST EN ISO 11990:2000
© ISO
ISO 11990:1999(E)
Introduction
Surgery in the airway in which a laser is used brings together an oxygen-enriched atmosphere, fuel, and high
energy that can combine to create a fire. In the early to middle 1980s, the increasing use of such lasers was
followed by airway fires and the subsequent development of tracheal tubes designed specifically to be resistant to
laser ignition and damage. Unfortunately, some of these tubes were not sufficiently resistant under operating room
conditions, and airway fires continued to occur. These events lead to the development of the test method described
in this International Standard, in order to assist the clinician in determining which tracheal tube shaft is most laser-
resistant for a defined set of conditions.
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SIST EN ISO 11990:2000
INTERNATIONAL STANDARD  © ISO ISO 11990:1999(E)
Optics and optical instruments — Lasers and laser-related
equipment — Determination of laser resistance of tracheal tube
shafts
1 Scope
This International Standard specifies a method of testing the laser resistance of the shaft of a tracheal tube. Other
components of the system, such as the inflation system and cuff, are outside the scope of this International
Standard. The specified test method should be used to measure and describe the properties of materials, products
or assemblies in response to heat and flame under controlled laboratory conditions and should not be used to
describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions.
However, results of this test may be used as elements of a fire risk assessment which takes into account all of the
factors which are pertinent to an assessment of the hazard of a particular end use.
NOTE 1 Caution should be observed in interpreting these results, since the direct applicability of the result of this test
method to the clinical situation has not been fully established.
NOTE 2 This test method may involve hazardous materials, operations, and equipment. This International Standard does not
purport to address all of the safety problems associated with its use. It is the responsibility of the user of this test method to
establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent edition of the normative document indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 11146: 1999, Lasers and laser-related equipment — Test methods for laser beam parameters — Beam widths,
divergence angle and beam propagation factor.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
laser resistance
measure of the ability of a material to withstand laser power without burning or damage
3.2
burning
chemical process of oxidation with the liberation of heat
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SIST EN ISO 11990:2000
© ISO
ISO 11990:1999(E)
3.3
combustion
any continuing burning process that occurs in or on the test specimen
EXAMPLES Flame, smoldering, rapid evolution of smoke.
3.4
ignition
creation of propagated combustion induced by the application of energy, usually heat
3.5
damage
any change , other than combustion, which may affect the safety of the patient or efficacy of the shaft of the tracheal
tube
EXAMPLES Local heating, melting, creation of holes, pyrolysis.
3.6
blemish
any apparent physical change to the shaft of the tracheal tube, other than damage or combustion
EXAMPLES Discoloration, surface pitting, minor deformation.
3.7
shaft
portion of the tracheal tube between the cuff and the machine end of the tube
3.8
beam diameter
d
95
diameter of an aperture in a plane perpendicular to the beam axis which contains 95 % of the total beam power
(energy)
[ISO 11145]
3.9
beam cross-sectional area
A
95
smallest area containing 95 % of the total beam power (energy)
[ISO 11145]
4 Principle
To simulate worst-case conditions, the shaft of a tracheal tube is exposed to laser power of known characteristics
while in an environment of (98 ± 2) % oxygen.
WARNING — This test method can result in a rocket-like fire involving the tracheal tube. This fire can
produce high heat, intense light and toxic gases.
5 Significance and use of the test
5.1  This International Standard describes a uniform and repeatable measurement of the laser resistance of the
shaft of a tracheal tube. Most of the variables involved in laser ignition of a tracheal tube have been fixed in order to
establish a basis for comparison. This measurement can be used to compare tracheal tubes having differing
designs of laser protection.
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SIST EN ISO 11990:2000
© ISO
ISO 11990:1999(E)
A large number and range of variables are involved in laser ignition of a tracheal tube. A change in one
5.2
variable may affect the outcome of the test. Caution should be observed, since the direct applicability of the results
of this test method to the clinical situation has not been fully established.
5.3  Since it is conceivable that an oxygen-enriched atmosphere may be encountered in the clinical situation, either
intentionally or unintentionally, the test is performed in a environment of (98 ± 2) % oxygen.
5.4  A flowrate of 1 litre/min in a 6,0 mm inner diameter tube was chosen as the best conditions for tube ignition and
establishment of a fire based on studies detailed in [1] (see Bibliography).
5.5  Opportunities for development: variations of this method can be applied to study the effect of changing the test
conditions, but are outside the scope of this test method. For example, variation of the breathing-gas flowrate or
different breathing-gas mixtures may affect the laser resistance of the tracheal tube. Use of beam cross-sectional
areas other than circular or modes of laser power delivery other than continuous, e.g. pulsed, superpulsed,
Q-switched, ultrapulsed, may alter the tracheal tube's ignition characteristics. Also, tubes of different diameter will
have laser resistances different from that defined in this International Standard (see [2] to [5] in the Bibliography).
6 Apparatus
6.1 Gas supply system
6.1.1  The gas supply system shall provide oxygen to the tracheal tube at a controllable flowrate. Also, the system
shall be capable of rapidly flooding the containment box with nitrogen or other inert gas and/or stopping oxygen
flow, or both, to extinguish any burning material. An oxygen flow control and flow meter and a quick-action inert gas
valve should be part of this system (see Figure 1). The nitrogen or inert gas supplied should be at a higher pressure
and allow a flowrate at least an order of magnitude greater than that of the oxygen supplied to the tracheal tube.
6.1.2  Other arrangements, such as an oxygen flood valve for rapidly purging the containment box or an inert gas
flooding system for rapid extinguishment of burning material, may be made as long as the requirements of the test
method as defined herein are not affected.
6.2 Containment box
6.2.1  The containment box is a means to control the environment around the test specimen while allowing access
for the laser delivery system to the test unit (see Figure 2).
6.2.2  The typical containment box shall have the following characteristics:
a) allows direct access of th
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