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)

ISO 11990:2003 specifies a method of testing the continuous wave (cw) 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 ISO 11990:2003.
The specified test method shall be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions and shall 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 the factors which are pertinent to an assessment of the hazard of a particular end use. 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.

Optik und optische Instrumente - Laser und Laseranlagen - Bestimmung der Laserresistenz des Schafts von Trachealtuben (ISO 11990:2003)

Diese Internationale Norm legt ein Verfahren zur Prüfung der Laserresistenz des Schaftes eines Trachealtubus mit Dauerstrichlaser (cw) fest. Andere Komponenten des Systems, wie das Aufblassystem und die Manschette, gehören nicht zum Anwendungsbereich dieser Internationalen Norm.
Das angegebene Prüfverfahren muss angewendet werden, um die Eigenschaften der Materialien, Produkte und Zusammenbauten infolge der Einwirkung von Hitze und Flammen unter kontrollierten Laborbedingungen zu beschreiben. Es muss nicht angewendet werden, um die Feuergefahr oder das Brandrisiko von Materialien, Produkten und Zusammenbauten unter wirklichen Brandbedingungen zu beschreiben oder zu beurteilen. Jedoch dürfen Ergebnisse dieser Prüfung im Rahmen einer Brandrisikobetrachtung verwendet werden, die all jene Faktoren einbezieht, die zur Gefährdungsbestimmung eines besonderen Endzwecks dazugehören. Diese Ergebnisse sollten mit Vorsicht interpretiert werden, da die unmittelbare Anwendbarkeit des Ergebnisses dieses Prüfverfahrens auf die klinische Situation nicht umfassend abgesichert ist.
ANMERKUNG Dieses Prüfverfahren kann die Anwendung von gefährlichen Materialien, Handhabungen und Ausrüstungsgegenständen beinhalten. Diese Internationale Norm hat nicht den Anspruch, alle Sicherheitsprobleme anzusprechen, die sich bei ihrer Anwendung ergeben. Es liegt in der Verantwortung des Anwenders dieses Prüfverfahrens, die passenden Praktiken bezüglich Sicherheit und Gesundheit festzulegen sowie vor der Anwendung zu bestimmen, welche gesetzlichen Beschränkungen zu beachten sind.

Optique et instruments d'optique - Lasers et équipements associés aux lasers - Détermination de la résistance au laser des tubes trachéaux (ISO 11990:2003)

L'ISO 11990:2003 spécifie une méthode d'essai de la résistance à un laser fonctionnant en régime continu du tube proprement dit d'un tube trachéal. Les autres éléments du système, comme le système de gonflage et le ballonnet, n'entrent pas dans le domaine d'application de la présente Norme internationale.
La méthode d'essai spécifiée sera 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, et non pour décrire ou évaluer 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. Il convient d'interpréter ces résultats avec prudence, car l'applicabilité directe du résultat de cette méthode d'essai à la situation clinique n'a pas été complètement établie.

Optika in optični instrumenti – Laserji in laserska oprema – Ugotavljanje odpornosti sapničnih (endotrahealnih) tubusov proti laserskemu žarku (ISO 11990:2003)

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-2003
• Withdrawal Date: 07-Nov-2011
• 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: 08-Nov-2011
• Due Date: 01-Dec-2011
• Completion Date: 08-Nov-2011
• 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 11990:2003 - Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)

Relations

• Replaced By: 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)
• Effective Date: 01-Dec-2011
• Replaces: SIST EN ISO 11990:2000 - Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:1999)
• Effective Date: 01-Sep-2003

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11990:2003
01-september-2003
1DGRPHãþD
SIST EN ISO 11990:2000
2SWLNDLQRSWLþQLLQVWUXPHQWL±/DVHUMLLQODVHUVNDRSUHPD±8JRWDYOMDQMH
RGSRUQRVWLVDSQLþQLKHQGRWUDKHDOQLKWXEXVRYSURWLODVHUVNHPXåDUNX,62

Optics and optical instruments - Lasers and laser-related equipment - Determination of
laser resistance of tracheal tube shafts (ISO 11990:2003)
Optik und optische Instrumente - Laser und Laseranlagen - Bestimmung der
Laserresistenz des Schafts von Trachealtuben (ISO 11990:2003)
Optique et instruments d'optique - Lasers et équipements associés aux lasers -
Détermination de la résistance au laser des tubes trachéaux (ISO 11990:2003)
Ta slovenski standard je istoveten z: EN ISO 11990:2003
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 11990:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11990:2003

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SIST EN ISO 11990:2003
EUROPEAN STANDARD
EN ISO 11990
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2003
ICS 31.260 Supersedes EN ISO 11990:1999
English version
Optics and optical instruments - Lasers and laser-related
equipment - Determination of laser resistance of tracheal tube
shafts (ISO 11990:2003)
Optique et instruments d'optique - Lasers et équipements Optik und optische Instrumente - Laser und Laseranlagen -
associés aux lasers - Détermination de la résistance au Bestimmung der Laserresistenz des Schafts von
laser des tubes trachéaux (ISO 11990:2003) Trachealtuben (ISO 11990:2003)
This European Standard was approved by CEN on 21 February 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11990:2003 E
worldwide for CEN national Members.

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SIST EN ISO 11990:2003
EN ISO 11990:2003 (E)
CORRECTED  2003-07-02
Foreword
This document (EN ISO 11990:2003) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" in collaboration with Technical Committee CEN/TC 123 "Lasers
and laser-related equipment", 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 October 2003, and conflicting national
standards shall be withdrawn at the latest by October 2003.
This document supersedes EN ISO 11990:1999.
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(s), see informative annex ZB, 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, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 11990:2003 has been approved by CEN as EN ISO 11990:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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SIST EN ISO 11990:2003
EN ISO 11990:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 11146 1999 Laser and laser-related equipment - EN ISO 11146 1999
Test methods for laser beam
parameters - Beam widths, divergence
angle and beam propagation factor
3

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SIST EN ISO 11990:2003
EN ISO 11990:2003 (E)
Annex ZB
(informative)
Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives
This European Standard 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 93/42/EEC.
WARNING Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
Table ZB.1— Correspondence between this European Standard and EU Directives
Clause/subclause of this Corresponding Essential Comments
European Standard Requirement of Directive
93/42/EEC
The whole standard §§ I.1; I.2; I.3; II.7.1; II.7.3; II.9.2; The test method only
II.9.3; II.12.7.5
4

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SIST EN ISO 11990:2003
INTERNATIONAL ISO
STANDARD 11990
Second edition
2003-04-01
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

Reference number
ISO 11990:2003(E)
©
ISO 2003

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SIST EN ISO 11990:2003
ISO 11990:2003(E)
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Published in Switzerland
©
ii ISO 2003 – All rights reserved

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SIST EN ISO 11990:2003
ISO 11990:2003(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
5 Significance and use of the test . 2
6 Apparatus . 3
6.1 Gas supply system . 3
6.2 Containment box . 3
6.3 Smoke evacuation . 3
6.4 Lasers and delivery systems . 4
6.5 Oxygen analyser . 5
7 Reagents and materials . 6
8 Preparation of test specimen . 6
9 Preparation of apparatus . 6
10 Test procedure . 6
11 Interpretation of results . 8
12 Test report . 8
Bibliography . 10
©
ISO 2003 – All rights reserved iii

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SIST EN ISO 11990:2003
ISO 11990:2003(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.
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 was prepared by Technical Committee ISO/TC 172, Optics and optical instruments, Subcommittee
SC 9, Electro-optical systems.
This second edition cancels and replaces the first edition (ISO 11990:1999), Clause 12 of which has been
technically revised.
©
iv ISO 2003 – All rights reserved

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SIST EN ISO 11990:2003
ISO 11990:2003(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.
©
ISO 2003 – All rights reserved v

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SIST EN ISO 11990:2003
.
vi

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SIST EN ISO 11990:2003
INTERNATIONAL STANDARD ISO 11990:2003(E)
Optics and optical instruments — Lasers and laser-related
equipment — Determination of laser resistance of tracheal tube
shafts
1Scope
This International Standard specifies a method of testing the continuous wave (cw) 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 shall be used to measure and describe the properties of materials, products or
assemblies in response to heat and flame under controlled laboratory conditions and shall 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 the
factors which are pertinent to an assessment of the hazard of a particular end use. 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 This test method may involve hazardous materials, operations, and equipment. This International Standard does not
purport to address all 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 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 11146:1999, 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 document, the following terms and definitions apply.
3.1
laser resistance
measure of the ability of a material to withstand laser power without combustion or damage
3.2
combustion
any continuing burning process that occurs in or on the test specimen caused by chemical process of oxidation
with the liberation of heat
EXAMPLES Flame, smoldering, rapid evolution of smoke.
3.3
ignition
creation of combustion induced by the delivery of energy
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SIST EN ISO 11990:2003
ISO 11990:2003(E)
3.4
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.
3.5
blemish
any apparent physical change to the shaft of the tracheal tube, other than damage or combustion
EXAMPLES Discoloration, surface pitting, minor deformation.
3.6
shaft
portion of the tracheal tube between the cuff and the machine end of the tube
3.7
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)
NOTE Adapted from ISO 11145:2001.
3.8
beam cross-sectional area
A
95
smallest area containing 95 % of the total beam power (energy)
NOTE Adapted from ISO 11145:2001.
4Principle
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. Such a fire can
produce much heat,
...