EN ISO 11990-2:2014
(Main)Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)
ISO 11990‑2:2010 specifies a method of testing the continuous wave (cw) resistance of the cuff regions of tracheal tubes designed to resist ignition by a laser. Other components of the system, such as the inflation system and shaft are outside the scope of ISO 11990‑2:2010.
Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 2: Trachealtubusmanschetten (ISO 11990-2:2010)
Dieser Teil von ISO 11990 legt ein Verfahren zur Prüfung der Dauerstrichlaserresistenz (cw-Laser) des
Manschettenbereichs (Cuffbereichs) eines Trachealtubus fest, der dafür ausgelegt ist, der Entzündung durch
einen Laser standzuhalten. Andere Komponenten des Systems, wie das Aufblassystem und der Schaft (wie in
ISO 11990-1 festgelegt), gehören nicht zum Anwendungsbereich dieses Teils von ISO 11990.
ANMERKUNG 1 Das Verfahren zur Prüfung der Laserresistenz des Trachealtubusschaftes gehört zum
Anwendungsbereich der ISO 11990-1.
Das festgelegte Prüfverfahren 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 dürfen jedoch im Rahmen einer Beurteilung des Brandrisikos berücksichtigt werden, die all
jene Faktoren einbezieht, die zur Bestimmung der Gefährdung einer besonderen Endnutzung gehören.
ANMERKUNG 2 Die Interpretation dieser Ergebnisse sollte mit Umsicht erfolgen, weil die direkte Übertragbarkeit von
Ergebnissen dieses Prüfverfahrens auf die klinische Situation nicht immer gegeben ist.
ANMERKUNG 3 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 dieses Prüfverfahrens, die geeigneten praktischen Maßnahmen bezüglich Gesundheitsund
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 2: Ballonnet de tubes trachéaux (ISO 11990-2:2010)
L'ISO 11990-2:2010 spécifie une méthode d'essai de la résistance à un laser fonctionnant en régime continu des régions du ballonnet de tubes trachéaux conçus pour résister à l'ignition par un laser. Les autres composants du système, comme le système de gonflage et le tube proprement dit, n'entrent pas dans le domaine d'application de l'ISO 11990-2:2010.
Laserji in laserska oprema - Ugotavljanje odpornosti sapničnih (endotrahealnih) tubusov proti laserskemu žarku - 2. del: Sapnični (endotrahealni) tubusi (ISO 11990-2:2010)
Standard ISO 11990-2:2010 določa metodo za preskušanje trajne valovne (cw) odpornosti sapničnih (endotrahealnih) tubusov, zasnovanih tako, da so odporni na vžig z laserskim žarkom. Drugi sestavni deli sistema, kot sta sistem za napihovanje in obroč, so zunaj področja uporabe standarda ISO 11990-2:2010.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2015
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SIST EN ISO 11990-2:2010
/DVHUMLLQODVHUVNDRSUHPD8JRWDYOMDQMHRGSRUQRVWLVDSQLþQLK HQGRWUDKHDOQLK
WXEXVRYSURWLODVHUVNHPXåDUNXGHO 6DSQLþQL HQGRWUDKHDOQL WXEXVL ,62
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes
- Part 2: Tracheal tube cuffs (ISO 11990-2:2010)
Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 2:
Trachealtubusmanschetten (ISO 11990-2:2010)
Lasers et équipements associés aux lasers - Détermination de la résistance au laser des
tubes trachéaux - Partie 2: Ballonnet de tubes trachéaux (ISO 11990-2:2010)
Ta slovenski standard je istoveten z: EN ISO 11990-2:2014
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 11990-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.10; 31.260 Supersedes EN ISO 11990-2:2010
English Version
Lasers and laser-related equipment - Determination of laser
resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO
11990-2:2010)
Lasers et équipements associés aux lasers - Détermination Laser und Laseranlagen - Bestimmung der Laserresistenz
de la résistance au laser des tubes trachéaux - Partie 2: von Trachealtuben - Teil 2: Trachealtubusmanschetten (ISO
Ballonnet de tubes trachéaux (ISO 11990-2:2010) 11990-2:2010)
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 11990-2:2014 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) .4
Foreword
The text of ISO 11990-2:2010 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 11990-2:2014
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 11990-2:2010.
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 11990-2:2010 has been approved by CEN as EN ISO 11990-2:2014 without any modification.
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.
INTERNATIONAL ISO
STANDARD 11990-2
First edition
2010-07-15
Lasers and laser-related equipment —
Determination of laser resistance of
tracheal tubes —
Part 2:
Tracheal tube cuffs
Lasers et équipements associés aux lasers — Détermination de la
résistance au laser des tubes trachéaux —
Partie 2: Ballonnet de tubes trachéaux
Reference number
ISO 11990-2:2010(E)
©
ISO 2010
ISO 11990-2:2010(E)
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ii © ISO 2010 – All rights reserved
ISO 11990-2:2010(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 .2
6 Apparatus.3
6.1 Gas supply system.3
6.2 Containment box .4
6.3 Smoke evacuation device.7
6.4 Lasers and delivery systems.7
6.5 Oxygen analyser.7
7 Reagents and materials .8
8 Preparation of test specimens .8
9 Preparation of apparatus.8
10 Test procedure.9
11 Interpretation of results .10
12 Test report.10
Bibliography.11
ISO 11990-2:2010(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 11990-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9,
Electro-optical systems.
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 shafts
⎯ Part 2: Tracheal tube cuffs
iv © ISO 2010 – All rights reserved
ISO 11990-2:2010(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 may be blown into the lungs.
Procedures performed in the airway,
...
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