SIST EN ISO 11810-2:2009
(Main)Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
This part of ISO 11810 is applicable to disposable and re-usable, as well as woven and non-woven materials used as surgical drapes and/or patient protective covers which claim to be laser-resistant. The purpose of this part of ISO 11810 is to provide a standardized method for testing and classifying surgical drapes and/or patient protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this part of ISO 11810 to serve as a general fire safety specification. This part of ISO 11810 is limited to testing the secondary ignition of materials that are rated ?1 or ?2 from ISO 11810-1. All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflection may be a hazard. This measurement, however, is not covered in this part of ISO 11810. The results of this part of ISO 11810 are not to be applied to other wavelengths and temporal formats. The 20 W CO2 laser (continuous wave) has been selected as the laser to be used for this part of ISO 11810.
Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Teil 2: Sekundäre Entzündung (ISO 11810-2:2007)
Dieser Teil von ISO 11810 gilt für Einwegprodukte und wieder verwendbare gewebte Materialien und
Vliesstoffe, die als Operationstücher und andere Abdeckungen zum Schutz des Patienten mit dem Anspruch
auf Laserstrahlungsbeständigkeit verwendet werden.
Der Zweck dieses Teils von ISO 11810 ist, ein genormtes Verfahren zur Prüfung und Einstufung von
Operationsabdecktüchern und anderen Abdeckungen zum Schutz des Patienten hinsichtlich der durch Laser
hervorgerufenen Gefährdungen zur Verfügung zu stellen. Ein geeignetes Einstufungssystem wird angegeben.
Der Zweck dieses Teils von ISO 11810 besteht nicht darin, als allgemeine Brandsicherheitsvorschrift zu
dienen. Dieser Teil von ISO 11810 beschränkt sich darauf, ein Verfahren zur Prüfung der sekundären
Entzündung für Materialien festzulegen, die nach ISO 11810-1 mit I1 oder I2 bewertet wurden.
Alle Materialien reflektieren Anteile des Strahls, und es ist für den Anwender erforderlich, entscheiden zu
können, ob die spiegelnde Reflexion eine Gefährdung darstellen kann. Diese Messungen werden jedoch in
diesem Teil von ISO 11810 nicht erfasst.
Prüfergebnisse nach diesem Teil von ISO 11810 sollten nicht auf andere Wellenlängen und
Zeitverhaltensweisen angewendet werden.
Für diesen Teil von ISO 11810 wurde der 20-W-CO2-Laser (Dauerstrich) ausgewählt.
ANMERKUNG Die Anwender der nach diesem Verfahren geprüften Produkte werden warnend darauf hingewiesen,
dass die Laserstrahlungsbeständigkeit eines Operationstuches und/oder einer anderen Abdeckung zum Schutz des
Patienten von der Wellenlänge abhängt und dass das Tuch und/oder die Abdeckung bei der Wellenlänge geprüft werden
sollte, für die ihr Einsatz vorgesehen ist. Bei Prüfung unter Anwendung anderer Wellenlängen müssen die Leistungswerte
und Anregungsarten explizit angegeben werden.
Lasers et équipements associés aux lasers - Méthode d'essai et classification de la résistance au laser pour des draps chirurgicaux et/ou des couvertures de protection des patients - Partie 2: Inflammation secondaire (ISO 11810-2:2007)
L'ISO 11810-2:2007 s'applique aux matériaux non réutilisables et réutilisables, ainsi qu'aux matériaux tissés et non tissés utilisés comme draps chirurgicaux et à d'autres couvertures de protection des patients déclarés résistants au laser.
L'objectif de la présente partie de l'ISO 11810-2:2007 est de fournir une méthode d'essai et de classification normalisée des draps chirurgicaux et autres couvertures de protection des patients en fonction des risques liés au laser. Un système de classification approprié est indiqué. L'ISO 11810-2:2007 n'a pas pour objet de servir de spécification générale de sécurité contre le feu. Elle se limite aux essais d'inflammation secondaire des matériaux appartenant aux classes I1 et I2 définies dans l'ISO 11810-1.
Tous les matériaux réfléchissent des portions du faisceau laser, il est nécessaire que l'utilisateur décide si le facteur de réflexion spéculaire peut constituer un risque. Ce mesurage n'est cependant pas traité dans l'ISO 11810-2:2007.
Laserji in laserska oprema - Preskusna metoda in razvrstitev za ugotavljanje odpornosti proti laserju za kirurške zastirke in/ali za varovalna pokrivala za paciente - 2. del: Sekundarno zgorevanje (ISO 11810-2:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11810-2:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 11810-2:2007
Laserji in laserska oprema - Preskusna metoda in razvrstitev za ugotavljanje
odpornosti proti laserju za kirurške zastirke in/ali za varovalna pokrivala za
paciente - 2. del: Sekundarno zgorevanje (ISO 11810-2:2007)
Lasers and laser-related equipment - Test method and classification for the laser-
resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition
(ISO 11810-2:2007)
Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von
Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Teil 2:
Sekundäre Entzündung (ISO 11810-2:2007)
Lasers et équipements associés aux lasers - Méthode d'essai et classification de la
résistance au laser pour des draps chirurgicaux et/ou des couvertures de protection des
patients - Partie 2: Inflammation secondaire (ISO 11810-2:2007)
Ta slovenski standard je istoveten z: EN ISO 11810-2:2009
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
13.340.99 Druga varovalna oprema Other protective equipment
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
SIST EN ISO 11810-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11810-2:2009
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SIST EN ISO 11810-2:2009
EUROPEAN STANDARD
EN ISO 11810-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 13.340.99; 31.260; 11.040.30 Supersedes EN ISO 11810-2:2007
English Version
Lasers and laser-related equipment - Test method and
classification for the laser-resistance of surgical drapes and/or
patient-protective covers - Part 2: Secondary ignition (ISO
11810-2:2007)
Lasers et équipements associés aux lasers - Méthode Laser und Laseranlagen - Prüfverfahren und Einstufung zur
d'essai et classification de la résistance au laser pour des Laserresistenz von Operationstüchern und/oder anderen
draps chirurgicaux et/ou des couvertures de protection des Abdeckungen zum Schutz des Patienten - Teil 2:
patients - Partie 2: Inflammation secondaire (ISO 11810- Sekundäre Entzündung (ISO 11810-2:2007)
2:2007)
This European Standard was approved by CEN on 26 January 2009.
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, 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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11810-2:2009: E
worldwide for CEN national Members.
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SIST EN ISO 11810-2:2009
EN ISO 11810-2:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EC .4
2
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SIST EN ISO 11810-2:2009
EN ISO 11810-2:2009 (E)
Foreword
The text of ISO 11810-2:2007 has been prepared by Technical Committee ISO/TC 172 “Optics and optical
instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
11810-2:2009 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 September 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
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 11810-2:2007.
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.
For relationship with EC 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, 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 11810-2:2007 has been approved by CEN as a EN ISO 11810-2:2009 without any
modification.
3
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SIST EN ISO 11810-2:2009
EN ISO 11810-2:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EC
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 Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
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 this EN Essential Requirements (ERs) Qualifying remarks/Notes
of EU Directive 93/42/EEC
The entire standard §§ 1; 2; 3; 4; 7.1; 9.3; 12.7.5; 13.1 Only the test method and
the classification system
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 11810-2:2009
INTERNATIONAL ISO
STANDARD 11810-2
First edition
2007-05-01
Lasers and laser-related equipment —
Test method and classification for the
laser-resistance of surgical drapes and/or
patient-protective covers —
Part 2:
Secondary ignition
Lasers et équipements associés aux lasers — Méthode d'essai et
classification de la résistance au laser pour des draps chirurgicaux et/ou
des couvertures de protection des patients —
Partie 2: Inflammation secondaire
Reference number
ISO 11810-2:2007(E)
©
ISO 2007
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SIST EN ISO 11810-2:2009
ISO 11810-2:2007(E)
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ii © ISO 2007 – All rights reserved
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SIST EN ISO 11810-2:2009
ISO 11810-2:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Test methods. 2
4.1 General conditions . 2
4.1.1 Sampling. 2
4.1.2 Test equipment. 2
4.2 Testing procedure. 8
4.2.1 Sequence of testing. 8
4.2.2 Specimen preparation . 8
4.2.3 Laser-induced secondary ignition . 8
5 Classification. 9
5.1 Laser-induced secondary ignition of test material .9
5.2 Classification definition . 9
6 Test Report. 10
Bibliography . 11
© ISO 2007 – All rights reserved iii
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SIST EN ISO 11810-2:2009
ISO 11810-2:2007(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 11810-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9,
Electro-optical systems.
ISO 11810 consists of the following parts, under the general title Lasers and laser-related equipment — Test
method and classification for the laser-resistance of surgical drapes and/or patient-protective covers:
⎯ Part 1: Primary ignition and penetration
⎯ Part 2: Secondary ignition
For the purposes of this part of ISO 11810 the CEN annex regarding fulfilment of European Council Directives
will be removed at publication stage.
iv © ISO 2007 – All rights reserved
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SIST EN ISO 11810-2:2009
ISO 11810-2:2007(E)
Introduction
Some laser applications in medicine may require laser-resistant surgical drapes or other patient protective
covers. Surgical drapes or other patient protective covers are necessary when a sterile procedure is
performed and the surrounding area needs to be protected from liquids, secretions and inadvertent laser
radiation. While conventional surgical drapes or other patient protective covers are not necessarily laser-
resistant, specifically designed drapes offer the possibility of laser resistance.
Laser-induced risks include ignition, inflammability, melting, penetration, thermal transfer and reflectivity.
Textile and non-woven drape materials may have other risks but they may provide a laser barrier. While there
are many potential ignition devices present in the operating room, e.g. fibre optic illumination systems, electro-
surgical units, hot wire cauteries, etc., this test method addresses only the laser ignition source. A surgical
drape or other patient protective cover that claims to be laser-resistant must be tested according to this part of
ISO 11810.
CO lasers may provide the most challenging conditions of all medical lasers. Ignition/inflammability tests and
2
penetration tests may disclose more challenging laser wavelengths as well as modes of laser delivery, for
example Q-switching in the nanosecond range. The 20 W CO laser (continuous wave) has been selected as
2
the laser to be used for this part of ISO 11810. For laser-induced secondary ignition of drapes and/or patient
protective covers, the risk is dependent on spot size at a given power setting. In addition, areas within a given
product may vary in material composition or design. Depending on the claims being made by the
manufacturer or end-user requirements, all areas within the product may need to be tested.
This part of ISO 11810 applies to secondary ignition and is provided with information additional to
ISO 11810-1 for testing and reporting test results. The purpose of secondary ignition is to simulate a situation
where a surgical drape or other protective cover is placed over another material. A piece of cotton gauze is
used to simulate this other material. This part of ISO 11810 determines whether ignition of the cotton gauze
will ignite the surgical drape and/or patient protective cover and whether the surgical drape and/or patient
protective cover will continue to burn once the burning cotton has been removed. The afterflame of the
surgical drape and/or protective cover is also determined.
The performance of laser resistant surgical drapes or other patient covers may be degraded when used in
combination rather than individually.
© ISO 2007 – All rights reserved v
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SIST EN ISO 11810-2:2009
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SIST EN ISO 11810-2:2009
INTERNATIONAL STANDARD ISO 11810-2:2007(E)
Lasers and laser-related equipment — Test method and
classification for the laser-resistance of surgical drapes and/or
patient-protective covers —
Part 2:
Secondary ignition
1 Scope
This part of ISO 11810 is applicable to disposable and re-usable, as well as woven and non-woven materials
used as surgical drapes and/or patient protective covers which claim to be laser-resistant.
The purpose of this part of ISO 11810 is to provide a standardized method for testing and classifying surgical
drapes and/or patient protective covers with respect to laser-induced hazards. An appropriate classification
system is given. It is not the purpose of this part of
...
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