Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)

This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of
a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist
ignition by a laser.
NOTE 1 When interpreting these results, the attention of the user is drawn to the fact that the direct
applicability of the results of this test method to the clinical situation has not been fully established.
NOTE 2 The attention of the users of products tested by this method is drawn to the fact that the laser will
be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other
wavelengths, explicitly state the power settings and modes of delivery.
CAUTION — This test method can involve hazardous materials, operations and equipment. This
document provides advice on minimizing some of the risks associated with its use but does not
purport to address all such risks. It is the responsibility of the user of this document to establish
appropriate safety and health practices and to determine the applicability of regulatory
limitations prior to use.

Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtubusschaft und Trachealtubusmanschette (ISO 11990:2018)

Lasers et équipements associés aux lasers - Détermination de la résistance au laser des axe et ballonnet de tubes trachéaux (ISO 11990:2018)

Le présent document spécifie une méthode d'essai de la résistance au laser à onde continue d'une sonde trachéale et des régions du ballonnet conçus pour résister à l'inflammation par un laser.
NOTE 1 L'attention est attirée sur l'interprétation de ces résultats, car l'applicabilité directe des résultats de cette méthode d'essai à la situation clinique n'a pas été complètement établie.
NOTE 2 L'attention des utilisateurs des produits soumis à essai selon cette méthode est attirée sur le fait que le laser sera sensible à la longueur d'onde et que l'essai sera réalisé à la longueur d'onde pour laquelle il est destiné à être utilisé. En cas d'essai réalisé en utilisant d'autres longueurs d'onde, indiquer explicitement les paramètres de puissance et les modes d'émission.
ATTENTION — Cette méthode d'essai peut impliquer des matériaux, des fonctionnements et des équipements dangereux. Le présent document dispense des conseils sur la manière de minimiser certains risques associés à l'utilisation, mais n'a pas pour but de les traiter tous. Il incombe à l'utilisateur du présent document d'établir des pratiques appropriées en matière d'hygiène et de sécurité, et de déterminer l'applicabilité des limites réglementaires avant utilisation.

Laserji in laserska oprema - Ugotavljanje odpornosti sapničnih (endotrahealnih) tubusov in manšete proti laserskemu žarku (ISO 11990:2018)

Ta dokument določa metodo preskušanje trajne valovne (CW) laserske odpornosti sapničnih (endotrahealnih) tubusov in delov manšete, vključno s sistemom za napihovanje endotrahealnih tubusov, ki so namenjeni za preprečevanje vžiga z laserskim žarkom.
OPOMBA 1: Pri razlagi teh rezultatov je treba uporabnika opozoriti, da neposredna uporabnost rezultatov te preskusne metode za klinične postopke ni bila v celoti ugotovljena. OPOMBA 2: Uporabnike izdelkov, preskušenih s to metodo, je treba opozoriti, da bo laser občutljiv na valovno dolžino in da je preskus priporočljivo izvesti pri valovni dolžini, za katero je predvidena njegova uporaba. Če se preskus izvede pri drugih valovnih dolžinah, je treba izrecno navesti nastavitve moči in načine izvedbe.
OPOZORILO: Ta preskusna metoda lahko vključuje nevarne materiale, postopke in opremo. Ta dokument podaja nasvete o zmanjševanju nekaterih tveganj, povezanih z njeno uporabo, vendar ne obravnava vseh takšnih tveganj. Za vzpostavitev ustreznih varnostnih in zdravstvenih praks ter za določitev uporabnosti regulativnih omejitev pred uporabo je odgovoren uporabnik tega dokumenta.

General Information

Status
Published
Public Enquiry End Date
14-Jun-2017
Publication Date
12-Nov-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Nov-2018
Due Date
10-Jan-2019
Completion Date
13-Nov-2018

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SLOVENSKI STANDARD
SIST EN ISO 11990:2018
01-december-2018
1DGRPHãþD
SIST EN ISO 11990-1:2015
SIST EN ISO 11990-2:2015
/DVHUMLLQODVHUVNDRSUHPD8JRWDYOMDQMHRGSRUQRVWLVDSQLþQLK HQGRWUDKHDOQLK
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Lasers and laser-related equipment - Determination of laser resistance of tracheal tube

shaft and tracheal cuffs (ISO 11990:2018)

Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtubusschaft und

Trachealtubusmanschette (ISO 11990:2018)

Lasers et équipements associés aux lasers - Détermination de la résistance au laser des

axe et ballonnet de tubes trachéaux (ISO 11990:2018)
Ta slovenski standard je istoveten z: EN ISO 11990:2018
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 11990:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11990:2018
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SIST EN ISO 11990:2018
EN ISO 11990
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 31.260; 11.040.10 Supersedes EN ISO 11990-1:2014, EN ISO 11990-
2:2014
English Version
Lasers and laser-related equipment - Determination of
laser resistance of tracheal tube shaft and tracheal cuffs
(ISO 11990:2018)

Lasers et équipements associés aux lasers - Laser und Laseranlagen - Bestimmung der

Détermination de la résistance au laser des axe et Laserresistenz von Trachealtubusschaft und

ballonnet de tubes trachéaux (ISO 11990:2018) Trachealtubusmanschette (ISO 11990:2018)

This European Standard was approved by CEN on 5 August 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11990:2018 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11990:2018
EN ISO 11990:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Annex ZA (informative) Relationship between this European standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered ...................................... 4

---------------------- Page: 4 ----------------------
SIST EN ISO 11990:2018
EN ISO 11990:2018 (E)
European foreword

This document (EN ISO 11990:2018) has been prepared by Technical Committee ISO/TC 172 "Optics

and photonics" in collaboration with Technical Committee CEN/TC 123 “Lasers and photonics” the

secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by April 2019, and conflicting national standards shall be

withdrawn at the latest by April 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 11990-1:2014 and EN ISO 11990-2:2014.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this

document.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 11990:2018 has been approved by CEN as EN ISO 11990:2018 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 11990:2018
EN ISO 11990:2018 (E)
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered

This European Standard has been prepared under a Commission’s standardization request ‘M/023

concerning the development of European standards related to medical devices’ to provide one

voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of

14 June 1993 concerning medical devices [OJ L 169].

Once this standard is cited in the Official Journal of the European Union under that Directive,

compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of

the scope of this standard, a presumption of conformity with the corresponding essential requirements

of that Directive, and associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This

means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’

or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential

Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC [OJ L

169]
Essential Requirements of Clause(s)/sub-clause(s) of
Remarks/Notes
Directive 93/42/EEC this European Standard
7.1 (first indent only) This entire standard These Essential Requirements
(ERs) are partly covered. This
7.3 (first part only) This entire standard
standard is intended to
provide a test method that will
9.3 This entire standard
allow an evaluation of the risk
of ignition of the shaft and cuff
of a tracheal tube associated
with its use with lasers during
ear, nose and throat surgery as
part of the risk assessment as
set out in these essential
requirements.
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SIST EN ISO 11990:2018
EN ISO 11990:2018 (E)

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European

Standard is maintained in the list published in the Official Journal of the European Union. Users of this

standard should consult frequently the latest list published in the Official Journal of the European

Union.

WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of

this standard.

The following referenced documents are indispensable for the application of this document. For

undated references, the latest edition of the referenced document (including any amendments) applies.

For dated references, only the edition cited applies. However, for any use of this standard ‘within the

meaning of Annex ZA’, the user should always check that any referenced document has not been

superseded and that its relevant contents can still be considered the generally acknowledged state-of-

art.

When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a

normative reference to the corresponding EN standard, if available, and otherwise to the dated version

of the ISO or IEC standard, as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the

extent (in whole or in part) to which they apply.

Table — Correlations between undated normative references and dated EN and ISO standards

Normative references as Equivalent dated standard
listed in Clause 2
EN ISO
ISO 11146-1 EN ISO 11146-1:2005 ISO 11146-1:2005
ISO 11810 EN ISO 11810:2015 EN ISO 11810:2015
ISO/IEC Guide 99 — ISO/IEC Guide 99:2007
ISO 5361:2016 EN ISO 5361:2016 ISO 5361:2016
ISO 11145:2016 EN ISO 11145:2016 ISO 11145:2016
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SIST EN ISO 11990:2018
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SIST EN ISO 11990:2018
INTERNATIONAL ISO
STANDARD 11990
Third edition
2018-08
Lasers and laser-related
equipment — Determination of laser
resistance of tracheal tube shaft and
tracheal tube cuffs
Lasers et équipements associés aux lasers — Détermination de la
résistance au laser des axe et ballonnet de tubes trachéaux
Reference number
ISO 11990:2018(E)
ISO 2018
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SIST EN ISO 11990:2018
ISO 11990:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 11990:2018
ISO 11990:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principle ........................................................................................................................................................................................................................ 3

5 Significance and use of the test.............................................................................................................................................................. 3

6 Apparatus ..................................................................................................................................................................................................................... 4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Containment box ................................................................................................................................................................................... 4

6.3 Specimen holder .................................................................................................................................................................................... 5

6.4 Lasers and delivery systems ........................................................................................................................................................ 7

6.5 Power meter .............................................................................................................................................................................................. 7

6.6 Gas supply system ................................................................................................................................................................................ 7

6.7 Environment ............................................................................................................................................................................................. 7

6.7.1 Ambient air conditions ............................................................................................................................................... 7

6.7.2 Oxygen enriched atmospheres ............................................................................................................................ 8

6.8 Smoke evacuation device ............................................................................................................................................................... 8

7 Reagents and materials ................................................................................................................................................................................. 8

8 Preparation of test specimens ................................................................................................................................................................ 8

9 Preparation of apparatus ............................................................................................................................................................................ 9

10 Test methods ............................................................................................................................................................................................................. 9

10.1 General conditions ............................................................................................................................................................................... 9

10.2 Shaft .................................................................................................................................................................................................................. 9

10.3 Cuff .................................................................................................................................................................................................................10

11 Interpretation of results ............................................................................................................................................................................11

12 Test report ................................................................................................................................................................................................................11

Bibliography .............................................................................................................................................................................................................................13

© ISO 2018 – All rights reserved iii
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SIST EN ISO 11990:2018
ISO 11990:2018(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee

SC 9, Laser and electro-optical systems.

This third edition of ISO 11990 cancels and replaces ISO 11990-1:2011 and ISO 11990-2:2010 which

have undergone a revision in order to adjust the two documents to each other thereby eliminating

redundancies and unintended discrepancies.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 11990:2018
ISO 11990:2018(E)
Introduction

A fire in the airway is always a serious matter. In addition to local damage in the larynx, injury can

occur to the lower airway and the parenchymal tissue in the lung. The products of combustion can be

blown into the lungs.

Procedures performed in the airway, where a tracheal tube and a laser are used, bring together an

oxygen-enriched atmosphere, a fuel and high power, the three ingredients necessary to create a fire. The

likelihood that a laser beam will contact the tracheal tube during airway procedures is high. This led

to the development of a test method, described in this document, to assist the clinician in determining

which tracheal tube shaft was the most laser-resistant under a defined set of conditions.

Unfortunately, fires with tracheal tubes, whose shafts were laser-resistant according to this document

have continued to occur. Investigations have shown that the cuff, and not the shaft, of the tracheal tube

is the area of lowest laser resistance and most likely to be contacted by the laser beam, even when used

according to the manufacturer's instructions. Clinical experience has shown that not only perforation

of the part of the shaft below the cuff has happened, but also ignition of the outer surface of the cuff.

This could then ignite other parts of the tracheal tube, such as the tip, which is normally unprotected.

© ISO 2018 – All rights reserved v
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SIST EN ISO 11990:2018
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SIST EN ISO 11990:2018
INTERNATIONAL STANDARD ISO 11990:2018(E)
Lasers and laser-related equipment — Determination of
laser resistance of tracheal tube shaft and tracheal tube
cuffs
1 Scope

This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of

a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist

ignition by a laser.

NOTE 1 When interpreting these results, the attention of the user is drawn to the fact that the direct

applicability of the results of this test method to the clinical situation has not been fully established.

NOTE 2 The attention of the users of products tested by this method is drawn to the fact that the laser will

be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other

wavelengths, explicitly state the power settings and modes of delivery.

CAUTION — This test method can involve hazardous materials, operations and equipment. This

document provides advice on minimizing some of the risks associated with its use but does not

purport to address all such risks. It is the responsibility of the user of this document to establish

appropriate safety and health practices and to determine the applicability of regulatory

limitations prior to use.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 11146-1, Lasers and laser-related equipment — Test methods for laser beam widths, divergence angles

and beam propagation ratios — Part 1: Stigmatic and simple astigmatic beams

ISO 11810, Lasers and laser-related equipment — Test method and classification for the laser resistance

of surgical drapes and/or patient protective covers — Primary ignition, penetration, flame spread and

secondary ignition

ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated

terms (VIM)

ISO 5361:2016, Anaesthetic and respiratory equipment — Tracheal tubes and connectors

ISO 11145:2016, Optics and photonics — Lasers and laser-related equipment — Vocabulary and symbols

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 11810, ISO/IEC Guide 99 and

the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at https: //www .electropedia .org/
© ISO 2018 – All rights reserved 1
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SIST EN ISO 11990:2018
ISO 11990:2018(E)
3.1
beam diameter

smallest diameter of a circular aperture in a plane perpendicular to the beam axis that contains 95 % of

the total beam power (energy)

[SOURCE: ISO 11145:2016, 3.3.1, modified — The value of contained total beam power has been set to

95 %, and the note to entry has been removed.]
3.2
beam cross-sectional area
smallest completely filled area containing 95 % of the total beam power (energy)

[SOURCE: ISO 11145:2016, 3.2.1, modified — The value of contained total beam power has been set to

95 %, and the note to entry has been removed.]
3.3
combustion

any continuing burning process that occurs in or on the specimen caused by a chemical process of

oxidation with the liberation of heat
EXAMPLE Flame, smouldering, rapid evolution of smoke.
[SOURCE: ISO 11810:2015, 3.7]
3.4
cuff

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

effective seal between the tube and the trachea
[SOURCE: ISO 5361:2016, 3.4]
3.5
damage

any change, other than combustion, which can affect the safety of the patient or efficacy of the tracheal

tube due to increasing the risk of ignition
EXAMPLE Local heating, melting, creation of holes, pyrolysis.

[SOURCE: ISO 11810:2015, 3.8, modified — “product” has been replaced with “tracheal tube”.]

3.6
flammable
subject to ignition and flaming combustion
[SOURCE: ISO 11810:2015, 3.9]
3.7
ignition
creation of combustion induced by the delivery of power
[SOURCE: ISO 11810:2015, 3.10]
3.8
laser resistance

measure of the ability of a material to withstand laser power without ignition or damage

[SOURCE: ISO 11810:2015, 3.11]
2 © ISO 2018 – All rights reserved
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SIST EN ISO 11990:2018
ISO 11990:2018(E)
3.9
melting behaviour

softening of a material under the influence of heat (including shrinking, dripping and burning of molten

material, etc.)
[SOURCE: ISO 11810:2015, 3.12]
3.10
penetration resistance
ability of a material to prevent the passage of laser energy
[SOURCE: ISO 11810:2015, 3.14]
3.11
shaft
portion of the tracheal tube between the cuff and the machine end of the tube
4 Principle

WARNING — This test method can result in a rocket-like fire involving the tracheal tube. Such a

fire can produce intense heat and light and toxic gases.

To simulate worst-case conditions, the material is exposed to laser power of known characteristics in

an environment of up to 98 % ± 2 % oxygen.
5 Significance and use of the test

5.1 This document describes a uniform and repeatable test method for measuring the laser resistance

of the shaft and the cuff 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 test method for measuring can be

used to compare tracheal tubes having differing types and designs of laser protection.

5.2 A large number and range of variables are involved in the ignition of a tracheal tube. A change in

one variable can 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.

NOTE 1 This method can be applied to study the effect of changing the test conditions, but this is outside the

scope of this document. For example, variation of the breathing-gas flow rate or different breathing-gas mixtures

might affect the laser resistance of the shaft and cuff of a tracheal tube.

5.3 Since an oxygen-enriched atmosphere is often present in the clinical situation, either intentionally

or unintentionally, the test is performed in an environment of 98 % ± 2 % oxygen.

5.4 A flow rate of 1 l/min of oxygen in a 6,0 mm inner diameter tube was chosen as the most appropriate

condition for shaft and cuff ignition and establishment of a fire, based on the work cited in Reference [5].

5.5 The preparation of the specimen shall be in accordance with the manufacturer's instructions for use.

5.6 Use of beam cross-sectional shape other than circular, or mode of laser power delivery other than

continuous wave can affect the shaft and cuff ignition characteristics. Also, shafts and cuff of different

construction have different laser resistances (see References [5] to [12]).

5.7 The majority of manufacturers of laser-resistant cuffs recommend using isotonic saline or water

to fill the cuff. For preliminary testing of leakage of the cuff, filling with air is recommended by most

manufacturers. This can cause an air bubble, which, in a typical position of the patient during surgery,

is not on the top of the filled cuff, but at the area where the cuff and shaft meet. The test report shall

© ISO 2018 – All rights reserved 3
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SIST EN ISO 11990:2018
ISO 11990:2018(E)

include whether a bubble occurs and, if so, report if the bubble fills out the space between the cuff and

the underlying shaft material, and whether the shaft material in the cuff region is laser-resistant or not.

NOTE 2 This method can be applied to study the effect of changing the test conditions, but this is outside the

scope of this document.
6 Apparatus
6.1 General

6.1.1 The test apparatus shall consist of a draught-resistant ventilated containment box, specimen

holder, specimen rack, laser energy source and associated parts (see Figure 1).
Key
1 test specimen 6 flashback arrestor
2 specimen holder using two clamps 7 oxygen
...

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