SIST EN ISO 11990-2:2010
(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)
This part of ISO 11990 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 (as defined in ISO 11990-1), are outside the scope of this part of ISO 11990. The specified test method 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 method may be used as an element of a fire risk assessment which takes into account all of the factors that are pertinent to an assessment of the hazard of a particular end use.
Laser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 2: Trachealtubusmanschetten (ISO 11990-2:2010)
Diese Internationale Norm legt ein Verfahren zur Prüfung der Laserresistenz aller Teile des Manschettenbereichs
(Cuffbereichs) eines Trachealtubus mit Dauerstrichlaser (cw-Laser) [zu englisch continous wave
laser] fest und ist anwendbar auf Trachealtuben, die dafür ausgelegt sind, der Entzündung durch einen Laser
standzuhalten. Andere Komponenten des Systems, wie das Aufblassystem und der Schaft (wie in Teil 1 der
vorliegenden Internationalen Norm festgelegt), gehören nicht zum Anwendungsbereich dieser Internationalen
Norm.
ANMERKUNG 1 Das Verfahren zur Prüfung der Laserresistenz des Trachealtubusschaftes ist Gegenstand des
Anwendungsbereichs von ISO 11990, die Teil 1 der vorliegenden Internationalen Norm wird.
Das festgelegte Prüfverfahren muss 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 ist nicht anwendbar, um die Feuergefahr oder das Brandrisiko von
Materialien, Produkten und Montageeinheiten unter wirklichen Brandbedingungen zu beschreiben oder zu
beurteilen. Ergebnisse dieser Prüfung dürfen jedoch im Rahmen einer Beurteilung des Brandrisikos berücksichtigt
werden, die all jene Faktoren einbezieht, die zur Bestimmung der Gefährdung eines besonderen
Endnutzung gehören.
ANMERKUNG 2 Die Interpretation dieser Ergebnisse sollte mit Umsicht erfolgen, weil die direkte Anwendbarkeit von
Ergebnissen dieses Prüfverfahrens auf die klinischen Situation nicht umfassend begründet ist.
ANMERKUNG 3 Dieses Prüfverfahren kann die Anwendung von gefährlichen Materialien, Handhabungen und
Ausrüstungsgegenständen umfassen. Diese Internationale Norm erhebt nicht den Anspruch, alle Sicherheitsprobleme
anzusprechen, die sich mit deren Anwendung ergeben.
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)
Ta del ISO 11990 določa metodo preskušanja odpornosti proti trajnemu valovanju manšentnih predelov sapničnih tubusov, odpornih proti vžigu z laserjem. Drugi sestavni deli sistema, kot sta sistem za napihovanje in os (kot opredeljuje ISO 11990-1), so zunaj področja uporabe tega dela ISO 11990. Določene preskusne metode se lahko uporabljajo za merjenje in opis lastnosti materialov, proizvodov ali sklopov kot odziv na vročino in ogenj pod nadzorovanimi laboratorijskimi pogoji. Ne opisuje in ne ocenjuje požarne nevarnosti ali tveganja materialov, proizvodov ali sklopov v dejanskih okoliščinah klinične uporabe. Rezultati te preskusne metode pa se lahko uporabijo kot element ocene požarnega tveganja, ki upošteva vse dejavnike, kateri se nanašajo na oceno nevarnosti pri določeni končni uporabi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11990-2:2010
01-oktober-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 11990-2:2010
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 11990-2:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11990-2:2010
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SIST EN ISO 11990-2:2010
EUROPEAN STANDARD
EN ISO 11990-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2010
ICS 11.040.10; 31.260
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
Ballonnet de tubes trachéaux (ISO 11990-2:2010) (ISO 11990-2:2010)
This European Standard was approved by CEN on 23 June 2010.
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 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 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11990-2:2010: E
worldwide for CEN national Members.
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SIST EN ISO 11990-2:2010
EN ISO 11990-2:2010 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 11990-2:2010
EN ISO 11990-2:2010 (E)
Foreword
This document (EN ISO 11990-2:2010) 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 January 2011, and conflicting national standards shall be withdrawn at
the latest by January 2011.
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 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, 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 11990-2:2010 has been approved by CEN as a EN ISO 11990-2:2010 without any
modification.
3
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SIST EN ISO 11990-2:2010
EN ISO 11990-2:2010 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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.
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.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential requirements (ERs) of Qualifying remarks/Notes
this European Standard EU Directive 93/42/EEC
This entire standard 1, 2, 3, 7.1 (first indent only), 7.3, 9.3 This European Standard is 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.
4
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SIST EN ISO 11990-2:2010
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
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SIST EN ISO 11990-2:2010
ISO 11990-2:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 11990-2:2010
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 2010 – All rights reserved iii
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SIST EN ISO 11990-2:2010
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
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SIST EN ISO 11990-2:2010
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, 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. This led to the development
of a test method, described in ISO 11990-1, to assist the clinician in determining which tracheal tube shaft was
the most laser-resistant under a defined set of conditions.
Unfortunately, fires with tracheal tubes, whose shafts were laser-resistant according to ISO 11990-1 have
continued to occur. Investigations have shown that the cuff, and not the shaft, of the tracheal tube is the area
of lowest laser resistance and most likely to be contacted by the laser beam, even when used according to the
manufacturer's instructions. Clinical experience has shown that not only perforation of the part of the shaft
below the cuff has happened, but also ignition of the outer surface of the cuff. This could then ignite other
parts of the tracheal tube, such as the tip, which is normally unprotected.
© ISO 2010 – All rights reserved v
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SIST EN ISO 11990-2:2010
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SIST EN ISO 11990-2:2010
INTERNATIONAL STANDARD ISO 11990-2:2010(E)
Lasers and laser-related equipment — Determination of laser
resistance of tracheal tubes —
Part 2:
Tracheal tube cuffs
1 Scope
This part of ISO 11990 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 (as defined in ISO 11990-1), are outside the scope of this part of ISO 11990.
NOTE 1 The method for testing the laser resistance of the tracheal tube shaft is in the scope of ISO 11990-1.
The specified test method 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 method may be used as an element of a fire risk assessment which takes into
account all of the factors that are pertinent to an assessment of the hazard of a particular end use.
NOTE 2 Caution should be observed in interpreting these results, since the direct applicability of the results of this test
method to the clinical situation has not been fully established.
NOTE 3 This test method might 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 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 11146-1, 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 2010 – All rights reserved 1
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SIST EN ISO 11990-2:2010
ISO 11990-2:2010(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 11145:2006.
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
EXAMPLE Flame, smouldering, rapid evolution of smoke.
3.4
cuff
inflatable balloon permanently attached around the tracheal tube near the patient end to provide an effective
seal between the tube and the trachea
[ISO 5361:1999, definition 3.3]
3.5
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
EXAMPLE Local heating, melting, creation of holes, pyrolysis.
3.6
ignition
creation of combustion induced by the delivery of power
3.7
laser resistance
measure of the ability of a material to withstand laser power without ignition or damage
4 Principle
WARNING — This test method can result in a rocket-like fire involving the tracheal tube. Such a fire
can produce intense heat and light and toxic gases.
To simulate worst-case conditions, the cuff of a tracheal tube is exposed to laser power of known
characteristics in an environment of 98 % ± 2 % oxygen.
5 Significance and use of the test
5.1 This part of ISO 11990 describes a uniform and repeatable test method for measuring the laser
resistance of the cuff of a tracheal tube. Most of the variables involved in laser ignition of a tracheal tube have
been fixed in order to establish a basis for comparison. This test method for measuring can be used to
compare tracheal tubes having differing types and designs of laser protection.
5.2 A large number and range of variables are involved in ignition of a tracheal tube cuff. A change in one
variable may affect the outcome of the test. Caution should be observed, since the direct applicability of the
results of this test method to the clinical situation has not been fully established.
2 ©
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.QGRWUDKHDOQLKLaser und Laseranlagen - Bestimmung der Laserresistenz von Trachealtuben - Teil 2: Trachealtubusmanschetten (ISO/DIS 11990-2:2008)Lasers et équipements associés aux lasers - Détermination de la résistance au laser des tubes trachéaux - Partie 2: Ballonnet de tubes trachéaux (ISO/DIS 11990-2:2008)Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO/DIS 11990-2:2008)31.260Optoelektronika, laserska opremaOptoelectronics. Laser equipment11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:prEN ISO 11990-2oSIST prEN ISO 11990-2:2009en01-marec-2009oSIST prEN ISO 11990-2:2009SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMDRAFTprEN ISO 11990-2October 2008ICS 11.040.10; 31.260 English VersionLasers and laser-related equipment - Determination of laserresistance of tracheal tubes - Part 2: Tracheal tube cuffs(ISO/DIS 11990-2:2008)Lasers et équipements associés aux lasers - Déterminationde la résistance au laser des tubes trachéaux - Partie 2:Ballonnet de tubes trachéaux (ISO/DIS 11990-2:2008)Laser und Laseranlagen - Bestimmung der Laserresistenzvon Trachealtuben - Teil 2: Trachealtubusmanschetten(ISO/DIS 11990-2:2008)This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical CommitteeCEN/TC 123.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and toprovide supporting documentation.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 11990-2:2008: E
prEN ISO 11990-2:2008 (E) 2 Contents Page Foreword.3
prEN ISO 11990-2:2008 (E) 3 Foreword This document (prEN ISO 11990-2:2008) has been prepared by Technical Committee ISO/TC 172 "Optics and optical instruments" in collaboration with Technical Committee CEN/TC 123 “Lasers and photonics” the secretariat of which is held by DIN. This document is currently submitted to the parallel Enquiry. 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 EC Directive(s). Endorsement notice The text of ISO/DIS 11990-2:2008 has been approved by
...
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