SIST EN ISO 11990-1:2015
(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)
Standard ISO 11990-1:2011 določa metodo za preskušanje trajne valovne (cw) odpornosti sapničnih (endotrahealnih) cevi z obroči, zasnovanih za odpornost proti laserskemu žarku. Ne uporablja se za druge sestavne dele sistema, kot sta sistem za napihovanje in manšeta, ki sta opredeljena v standardu ISO 11990-2:2010.
Standard ISO 11990-1:2011 je mogoče uporabiti za merjenje in opisovanje lastnosti materialov, izdelkov ali sestavov kot odziv na vročino ter plamene pod nadzorovanimi laboratorijskimi pogoji. Standard ne opisuje ali ocenjuje nevarnosti ali tveganja vžiga materialov, izdelkov ali sestavov pod dejanskimi pogoji klinične uporabe. Vendar je mogoče rezultate tega preskusa uporabiti kot element ocene tveganja vžiga, ki upošteva vse dejavnike, ki se nanašajo na oceno nevarnosti posamezne končne uporabe.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11990-1:2015
01-januar-2015
1DGRPHãþD
SIST EN ISO 11990-1:2011
/DVHUMLLQODVHUVNDRSUHPD8JRWDYOMDQMHRGSRUQRVWLVDSQLþQLK HQGRWUDKHDOQLK
WXEXVRYSURWLODVHUVNHPXåDUNXGHO 6DSQLþQD HQGRWUDKHDOQD 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 11990-1:2014
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 11990-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 11990-1:2015
---------------------- Page: 2 ----------------------
SIST EN ISO 11990-1:2015
EUROPEAN STANDARD
EN ISO 11990-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.10; 31.260 Supersedes EN ISO 11990-1:2011
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 22 October 2014.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11990-1:2014 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11990-1:2015
EN ISO 11990-1:2014 (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) .4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 11990-1:2015
EN ISO 11990-1:2014 (E)
Foreword
The text of ISO 11990-1:2011 has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”
of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11990-1:2014
by 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 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
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 11990-1:2011.
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.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11990-1:2011 has been approved by CEN as EN ISO 11990-1:2014 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 11990-1:2015
EN ISO 11990-1:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (Medical Devices)
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 on Medical Devices.
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.
NOTE 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 on Medical Devices
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this European Standard of Directive 93/42/EEC
This entire standard 7.1 (first indent only) This standard is intended to
provide a test method that will
This entire standard 7.3
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
This entire standard 9.3
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
---------------------- Page: 6 ----------------------
SIST EN ISO 11990-1:2015
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
---------------------- Page: 7 ----------------------
SIST EN ISO 11990-1:2015
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 copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11990-1:2015
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
---------------------- Page: 9 ----------------------
SIST EN ISO 11990-1:2015
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
---------------------- Page: 10 ----------------------
SIST EN ISO 11990-1:2015
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
---------------------- Page: 11 ----------------------
SIST EN ISO 11990-1:2015
---------------------- Page: 12 ----------------------
SIST EN ISO 11990-1:2015
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
---------------------- Page: 13 ----------------------
SIST EN ISO 11990-1:2015
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 tu
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.