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-Mar-2003
• Withdrawal Date: 31-Jul-2011
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: CEN/TC 123 - Lasers and photonics
• Drafting Committee: CEN/TC 123 - Lasers and photonics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Aug-2011
• Completion Date: 01-Aug-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: 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)

Relations

• Replaces: EN ISO 11990:1999 - Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:1999)
• Effective Date: 22-Dec-2008
• Replaced By: 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: 06-Aug-2011

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11990:2003
01-september-2003
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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 refe
...