SIST EN ISO 11990-2:2015
(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
SIST EN ISO 11990-2:2015
01-januar-2015
1DGRPHãþD
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
SIST EN ISO 11990-2:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11990-2:2015
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SIST EN ISO 11990-2:2015
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.
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SIST EN ISO 11990-2:2015
EN ISO 11990-2:2014 (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
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SIST EN ISO 11990-2:2015
EN ISO 11990-2:2014 (E)
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.
3
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SIST EN ISO 11990-2:2015
EN ISO 11990-2:2014 (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
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SIST EN ISO 11990-2:2015
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 11990-2:2015
ISO 11990-2:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 11990-2:2015
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 11990-2:2015
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 11990-2:2015
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 11990-2:2015
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SIST EN ISO 11990-2:2015
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 11990-2:2015
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 igniti
...
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