EN ISO 11990-1:2011
(Main)Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2011
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SIST EN ISO 11990:2003
/DVHUMLLQODVHUVNDRSUHPD8JRWDYOMDQMHRGSRUQRVWLVDSQLþQLK HQGRWUDKHDOQLK
WXEXVRYSURWLODVHUVNHPXåDUNXGHO 6DSQLþQD HQGRWUDKHDOQD FHY]REURþL
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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.
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
ISO 11990-1:2011(E)
© 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 copyright@iso.org
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Published in Switzerland
ii © ISO 2011 – All rights reserved
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 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
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.
INTERNATIONAL STANDARD ISO 11990-1:2011(E)
Lasers and laser-related equipment — D
...
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