SIST EN ISO 11990-1:2011

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)

ISO 11990-1:2011 specifies a method of testing the continuous wave (cw) resistance of the shaft of a tracheal tube designed to resist ignition by a laser. It is not applicable to other components of the system, such as the inflation system and cuff, which are defined in ISO 11990-2:2010.
ISO 11990-1:2011 can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use conditions. However, the results of this test can be used as one element of a fire risk assessment which takes into account all factors pertinent to an assessment of the hazard of a particular end use.

Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 1: Trachealtubusschaft (ISO 11990-1:2011)

Dieser Teil von ISO 11990 legt ein Verfahren zur Prüfung der Dauerstrichlaserresistenz (cw-Laser) des
Schaftes eines Trachealtubus fest, der dafür ausgelegt ist, der Entzündung durch einen Laser standzuhalten.
Er ist nicht anwendbar auf andere Komponenten des Systems, wie das Aufblassystem und die Manschette,
die in ISO 11990-2 festgelegt ist (siehe Anmerkung 1).
ANMERKUNG 1 ISO 11990-2 legt das Verfahren zur Prüfung der Laserresistenz der Trachealtubusmanschette fest.
Das in diesem Teil von ISO 11990 festgelegte Verfahren kann angewendet werden, um die Eigenschaften
von Materialien, Produkten oder Montageeinheiten als Reaktion auf die Einwirkung von Hitze und Flammen
unter kontrollierten Laborbedingungen zu beschreiben. Es beschreibt oder beurteilt nicht die Feuergefahr oder
das Brandrisiko von Materialien, Produkten und Montageeinheiten unter realen klinischen Einsatzbedingungen.
Die Ergebnisse dieser Prüfung können jedoch im Rahmen einer Beurteilung des Brandrisikos
berücksichtigt werden, die alle Faktoren einbezieht, die zur Bestimmung der Gefährdung einer besonderen
Endnutzung gehören.
ANMERKUNG 2 Die direkte Übertragbarkeit von Ergebnissen dieses Prüfverfahrens auf die klinische Situation ist nicht
immer gegeben.
ACHTUNG - Dieses Prüfverfahren kann die Anwendung von gefährlichen Materialien, Handhabungen
und Ausrüstungsgegenständen umfassen. Dieser Teil von ISO 11990 gibt Hinweise zur Minimierung
von Risiken, erhebt aber nicht den Anspruch, alle Sicherheitsprobleme, die sich mit deren Anwendung
ergeben, anzusprechen. Es liegt in der Verantwortung des Anwenders diesen Teils von ISO 11990, die
geeigneten praktischen Maßnahmen bezüglich Gesundheits- und Arbeitsschutz festzulegen und die
Anwendbarkeit von behördlichen Beschränkungen zu bestimmen.

Lasers et équipements associés aux lasers - Détermination de la résistance au laser des tubes trachéaux - Partie 1: Axe des tubes trachéaux (ISO 11990-1:2011)

L'ISO 11990-1:2011 spécifie une méthode d'essai de la résistance à un laser fonctionnant en régime continu d'un tube trachéal conçu pour résister à l'ignition provoquée par un laser. Elle ne s'applique pas aux autres éléments du système, comme le système de gonflage et le ballonnet qui sont définis dans l'ISO 11990-2:2010.
L'ISO 11990-1:2011 peut être utilisée pour mesurer et décrire les propriétés des matériaux, produits ou assemblages par rapport à la chaleur et à la flamme, en conditions de laboratoire contrôlées. Elle ne décrit pas, ni n'évalue le danger ou le risque de feu pour les matériaux, produits ou assemblages en conditions réelles de feu. Cependant, les résultats de cet essai peuvent constituer des éléments d'évaluation du risque de feu prenant en compte tous les facteurs pertinents pour l'évaluation du danger dans le cadre d'un usage particulier.

Laserji in laserska oprema - Ugotavljanje odpornosti sapničnih (endotrahealnih) tubusov proti laserskemu žarku - 1. del: Sapnična (endotrahealna) cev z obroči (ISO 11990-1:2011)

Ta del ISO 11990 določa metodo preskušanja odpornosti proti trajnemu valovanju sapničnih (endotrahealnih) tubusov, odpornih proti vžigu z laserjem. Ne velja za druge komponente sistema, kot sta sistem za napihovanje in manšeta, ki sta opredeljena v ISO 11990-2. Ta del ISO 11990 se lahko uporablja za merjenje in opis lastnosti materialov, proizvodov ali sklopov kot odziv na vročino in ogenj v nadzorovanih laboratorijskih okoliščinah. Ne opisuje in ne ocenjuje požarne nevarnosti ali tveganja materialov, proizvodov ali sklopov v dejanskih okoliščinah klinične uporabe. Rezultati tega preskusa se lahko uporabijo kot element ocene požarnega tveganja, upoštevajoč vse dejavnike, ki se nanašajo na oceno nevarnosti pri določeni končni uporabi.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 19-Jul-2011
• Publication Date: 08-Nov-2011
• Withdrawal Date: 02-Dec-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 03-Dec-2014
• Due Date: 26-Dec-2014
• Completion Date: 03-Dec-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 11990-1:2011 - Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)

Relations

• Replaces: SIST EN ISO 11990:2003 - Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)
• Effective Date: 01-Dec-2011
• Replaced By: SIST EN ISO 11990-1:2015 - Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
• Effective Date: 01-Jan-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11990-1:2011
01-december-2011
1DGRPHãþD
SIST EN ISO 11990:2003
/DVHUMLLQODVHUVNDRSUHPD8JRWDYOMDQMHRGSRUQRVWLVDSQLþQLKHQGRWUDKHDOQLK
WXEXVRYSURWLODVHUVNHPXåDUNXGHO6DSQLþQDHQGRWUDKHDOQDFHY]REURþL
,62
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes
- Part 1: Tracheal tube shaft (ISO 11990-1:2011)
Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 1:
Trachealtubusschaft (ISO 11990-1:2011)
Lasers et équipements associés aux lasers - Détermination de la résistance au laser des
tubes trachéaux - Partie 1: Axe des tubes trachéaux (ISO 11990-1:2011)
Ta slovenski standard je istoveten z: EN ISO 11990-1:2011
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 11990-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11990-1:2011

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SIST EN ISO 11990-1:2011


EUROPEAN STANDARD
EN ISO 11990-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2011
ICS 11.040.10; 31.260 Supersedes EN ISO 11990:2003
English Version
Lasers and laser-related equipment - Determination of laser
resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO
11990-1:2011)
Lasers et équipements associés aux lasers - Détermination Laser und Laseranlagen - Bestimmung der Laserresistenz
de la résistance au laser des tubes trachéaux - Partie 1: von Trachealtuben - Teil 1: Trachealtubusschaft (ISO
Axe des tubes trachéaux (ISO 11990-1:2011) 11990-1:2011)
This European Standard was approved by CEN on 31 July 2011.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11990-1:2011: E
worldwide for CEN national Members.

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SIST EN ISO 11990-1:2011
EN ISO 11990-1:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (Medical Devices Directive) .4

2

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SIST EN ISO 11990-1:2011
EN ISO 11990-1:2011 (E)
Foreword
This document (EN ISO 11990-1:2011) 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 February 2012, and conflicting national standards shall be withdrawn
at the latest by February 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11990:2003.
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 relationship with EU Directive, 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11990-1:2011 has been approved by CEN as a EN ISO 11990-1:2011 without any
modification.
3

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SIST EN ISO 11990-1:2011
EN ISO 11990-1:2011 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (Medical Devices Directive)
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC (Medical Devices Directive).
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC (Medical
Devices Directive)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive …
This entire standard. 1, 2, 3, 7.1 (first indent only), 7.3, This European Standard is
9.3 intended to provide a test
method that will allow an
evaluation of the risk of ignition
associated with the use of a
tracheal tube and lasers during
ear, nose and throat surgery as
part of the risk assessment as
set out in these essential
requirements.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.


4

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SIST EN ISO 11990-1:2011

INTERNATIONAL ISO
STANDARD 11990-1
First edition
2011-08-01

Lasers and laser-related equipment —
Determination of laser resistance of
tracheal tubes —
Part 1:
Tracheal tube shaft
Lasers et équipements associés aux lasers — Détermination de la
résistance au laser des tubes trachéaux —
Partie 1: Axe des tubes trachéaux




Reference number
ISO 11990-1:2011(E)
©
ISO 2011

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SIST EN ISO 11990-1:2011
ISO 11990-1:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2011
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 either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 11990-1:2011
ISO 11990-1:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Principle.2
5 Significance and use of the test .3
6 Apparatus.3
6.1 Gas supply system.3
6.2 Containment box .4
6.3 Smoke evacuation .5
6.4 Lasers and delivery systems.5
6.5 Oxygen analyser.6
7 Reagents and materials .6
8 Preparation of test specimen .6
9 Preparation of apparatus.6
10 Test procedure.7
11 Interpretation of results .8
12 Test report.8
Bibliography.10

© ISO 2011 – All rights reserved iii

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SIST EN ISO 11990-1:2011
ISO 11990-1:2011(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.
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 11990-1 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9,
Electro-optical systems.
This first edition of ISO 11990-1 cancels and replaces ISO 11990:2003, of which it constitutes a minor revision.
ISO 11990 consists of the following parts, under the general title Lasers and laser-related equipment —
Determination of laser resistance of tracheal tubes:
⎯ Part 1: Tracheal tube shaft
⎯ Part 2: Tracheal tube cuffs
iv © ISO 2011 – All rights reserved

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SIST EN ISO 11990-1:2011
ISO 11990-1:2011(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.
In the early to mid-1980s, the increasing use of such lasers was followed by airway fires and, subsequently,
the 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 led to the development of the test method described in this part of
ISO 11990, in order to assist the clinician in determining which tracheal tube shaft is most laser-resistant for a
defined set of conditions.

© ISO 2011 – All rights reserved v

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SIST EN ISO 11990-1:2011

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SIST EN ISO 11990-1:2011
INTERNATIONAL STANDARD ISO 11990-1:2011(E)

Lasers and laser-related equipment — Determination of laser
resistance of tracheal tubes —
Part 1:
Tracheal tube shaft
1 Scope
This part of ISO 11990 specifies a method of testing the continuous wave (cw) resistance of the shaft of a
tracheal tube designed to resist ignition by a laser. It is not applicable to other components of the system,
such as the inflation system and cuff, which are defined in ISO 11990-2 (see Note 1).
NOTE 1 ISO 11990-2 specifies the method for testing the laser resistance of the tracheal tube cuff.
This part of ISO 11990 can be used to measure and describe the properties of materials, products or
assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or
appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use conditions.
However, the results of this test can be used as one element of a fire risk assessment which takes into
account all factors pertinent to an assessment of the hazard of a particular end use.
NOTE 2 The direct applicability of the result of this test method to the clinical situation has not been fully established.
CAUTION — This test method can involve hazardous materials, operations, and equipment. This part
of ISO 11990 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 part of ISO 11990 to
establish appropriate safety and health practices and to determine the applicability of regulatory
limitations prior to use.
2 Normative references
The following referenced documents are indispensable for the application 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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
beam cross-sectional area
A
95
smallest area containing 95 % of the total beam power
[ISO 11990-2:2010]
© ISO 2011 – All rights reserved 1

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SIST EN ISO 11990-1:2011
ISO 11990-1:2011(E)
3.2
beam diameter
d
95
diameter of an aperture in a plane perpendicular to the beam axis which contains 95 % of the total beam
power
NOTE Adapted from ISO 11145.
[ISO 11990-2:2010]
3.3
combustion
any continuing burning process that occurs in or on the test specimen caused by a chemical process of
oxidation with the liberation of heat
EXAMPLES Flame, smouldering, rapid evolution of smoke.
[ISO 11990-2:2010]
3.4
damage
any change, other than combustion, which may affect the safety of the patient or efficacy of the tracheal tube
due to increasing the risk of ignition
EXAMPLES Local heating, melting, creation of holes, pyrolysis.
[ISO 11990-2:2010]
3.5
ignition
creation of combustion induced by the delivery of power
[ISO 11990-2:2010]
3.6
laser resistance
measure of the ability of a material to withstand laser power without ignition or damage
[ISO 11990-2:2010]
3.7
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 shaft of a tracheal tube is exposed to laser power of
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.QGRWUDKHDOQLKLaser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 1: Trachealtubusschaft (ISO/FDIS 11990-1:2011)Lasers et équipements associés aux lasers - Détermination de la résistance au laser des tubes trachéaux - Partie 1: Axe des tubes trachéaux (ISO/FDIS 11990-1:2011)Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO/FDIS 11990-1:2011)31.260Optoelektronika, laserska opremaOptoelectronics. Laser equipment11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 11990-1kSIST FprEN ISO 11990-1:2011en01-julij-2011kSIST FprEN ISO 11990-1:2011SLOVENSKI
STANDARD



kSIST FprEN ISO 11990-1:2011



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 11990-1
April 2011 ICS 11.040.10; 31.260 Will supersede EN ISO 11990:2003English Version
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO/FDIS 11990-1:2011)
Lasers et équipements associés aux lasers - Détermination de la résistance au laser des tubes trachéaux - Partie 1: Axe des tubes trachéaux (ISO/FDIS 11990-1:2011)
Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 1: Trachealtubusschaft (ISO/FDIS 11990-1:2011) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 123.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 11990-1:2011: EkSIST FprEN ISO 11990-1:2011



FprEN ISO 11990-1:2011 (E) 2 Contents Page Foreword .3 kSIST FprEN ISO 11990-1:2011



FprEN ISO 11990-1:2011 (E) 3 Foreword This document (FprEN ISO 11990-1:2011) 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 document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 11990:2003. 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). Endorsement notice The text of ISO/FDIS 11990-1:2011 has been approved by CEN as a FprEN ISO 11990-1:2011 without any modification.
kSIST FprEN ISO 11990-1:2011



kSIST FprEN ISO 11990-1:2011



Please see the administrative notes on page iii
RECIPIENTS OF THIS DRAFT ARE INVITED TOSUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICHTHEY ARE AWARE AND TO PROVIDE SUPPORT-ING DOCUMENTATION. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-LOGICAL, COMMERCIAL AND USER PURPOSES,DRAFT INTERNATIONAL STANDARDS MAY ONOCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STAN-DARDS TO WHICH REFERENCE MAY BE MADE INNATIONAL REGULATIONS.
Reference numberISO/FDIS 11990-1:2011(E)© ISO 2011 FINAL DRAFT ISO/TC 172/SC 9 Secretariat: DIN Voting begins on: 2011-03-17 Voting terminates on: 2011-05-17
INTERNATIONAL STANDARD ISO/FDIS11990-1Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft Lasers et équipements associés aux lasers — Détermination de la résistance au laser des tubes trachéaux Partie 1: Axe des tubes trachéaux
kSIST FprEN ISO 11990-1:2011



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kSIST FprEN ISO 11990-1:2011



ISO/FDIS 11990-1:2011(E) © ISO 2011 – All rights reserved iii ISO/CEN PARALLEL PROCESSING This Minor Revision has been developed within the International Organization for Standardization (ISO), and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. This final draft is hereby submitted to a parallel two-month approval vote in ISO and three-month UAP vote in CEN. Positive votes shall not be accompanied by comments. Negative votes shall be accompanied by the relevant technical reasons.
In accordance with the provisions of Council Resolution 15/1993, this document is circulated in the English language only.
kSIST FprEN ISO 11990-1:2011



ISO/FDIS 11990-1:2011(E) iv © ISO 2011 – All rights reserved Contents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Principle.2 5 Significance and use of the test.3 6 Apparatus.3 6.1 Gas supply system.3 6.2 Containment box.4 6.3 Smoke evacuation.5 6.4 Lasers and delivery systems.5 6.5 Oxygen analyser.6 7 Reagents and materials.6 8 Preparation of test specimen.6 9 Preparation of apparatus.6 10 Test procedure.7 11 Interpretation of results.8 12 Test report.8 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC (Medical Devices Directive).10 Bibliography.11
kSIST FprEN ISO 11990-1:2011



ISO/FDIS 11990-1:2011(E) © ISO 2011 – All rights reserved v 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. 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 11990-1 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9, Electro-optical systems. This first edition of ISO 11990-1 cancels and replaces ISO 11990:2003, of which it constitutes a minor revision. ISO 11990 consists of the following parts, under the general title Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes: ⎯ Part 1: Tracheal tube shaft ⎯ Part 2: Tracheal tube cuffs kSIST FprEN ISO 11990-1:2011



ISO/FDIS 11990-1:2011(E) vi © ISO 2011 – All rights reserved 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. In the early to mid-1980s, the increasing use of such lasers was followed by airway fires and, subsequently, the 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 led to the development of the test method described in this part of ISO 11990, in order to assist the clinician in determining which tracheal tube shaft is most laser-resistant for a defined set of conditions.
kSIST FprEN ISO 11990-1:2011



FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 11990-1:2011(E) © ISO 2011 – All rights reserved 1 Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft 1 Scope This part of ISO 11990 specifies a method of testing the continuous wave (cw) resistance of the shaft of a tracheal tube designed to resist ignition by a laser. It is not applicable to other components of the system, such as the inflation system and cuff, which are defined in ISO 11990-2 (see Note 1).
NOTE 1 ISO 11990-2 specifies the method for testing the laser resistance of the tracheal tube cuff. This part of ISO 11990 can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use
conditions. However, the results of this test can be used as one element of a fire risk assessment which takes into account all factors pertinent to an assessment of the hazard of a particular end use.
NOTE 2 The direct applicability of the result of this test method to the clinical situation has not been fully established. CAUTION — This test method can involve hazardous materials, operations, and equipment. This part of ISO 11990 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 part of ISO 11990 to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use. 2 Normative references The following referenced documents are indispensable for the application 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 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 beam cross-sectional area A95 smallest area containing 95 % of the total beam power [ISO 11990-2:2010] kSIST FprEN ISO 11990-1:2011



ISO/FDIS 11990-1:2011(E) 2 © ISO 2011 – All rights reserved 3.2 beam diameter d95 diameter of an aperture in a plane perpendicular to the beam axis which contains 95 % of the total beam power NOTE Adapted from ISO 11145. [ISO 11990-2:2010] 3.3
combustion any continuing burning process that occurs in or on the test specimen caused by a chemical process of oxidation with the liberation of heat EXAMPLES Flame, smouldering, rapid evolution of smoke. [ISO 11990-2:2010] 3.4 damage any change, other than combustion, which may affect the safety of the patient or efficacy of the tracheal tube due to increasing the risk of ignition EXAMPLES Local heating, melting, creation of holes, pyrolysis. [ISO 11990-2:2010] 3.5 ignition creation of combustion induced by the delivery of power [ISO 11990-2:2010] 3.6 laser resistance measure of the ability of a material to withstand laser power without ignition or damage [ISO 11990-2:2010] 3.7 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 shaft of a tracheal tube is exposed to laser power of known characteristics while in an environment of (98 ± 2) % oxygen. kSIST FprEN ISO 11990-1:2011



ISO/FDIS 11990-1:2011(E) © ISO 2011 – All rights reserved 3 5 Significance and use of the test 5.1 This part of ISO 11990 describes a uniform and repeatable test method for measuring 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 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 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. 5.3 Since an oxygen-enriched atmosphere is often present in the clinical situatio
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