EN ISO 11810:2015
(Main)Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
ISO 11810:2015 is applicable to disposable and reusable, as well as woven and non-woven materials used as surgical drapes and other patient-protective covers which claim to be laser-resistant. The purpose of this International Standard is to provide a standardized method for testing and classifying surgical drapes and other patient-protective covers with respect to laser-induced hazards. An appropriate classification system is given. It is not the purpose of this International Standard to serve as a general fire safety specification, and as such, this International Standard does not cover other sources of ignition.
All materials reflect portions of the beam and it is necessary for the user to decide whether specular reflectance can be a hazard. This measurement, however, is not covered in this International Standard.
The test procedure can be used to assess the laser induced flammability properties of non-laser-resistant items
NOTE Users of products tested by this method are cautioned that the laser resistance of a surgical drape and/or patient-protective cover will be wavelength sensitive and that a surgical drape and/or patient-protective cover are better tested at the wavelength for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly state the power settings and modes of delivery.
Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Primäre Entzündung, Laserdurchstrahlung und sekundäre Entzündung (ISO 11810:2015)
Diese Internationale Norm gilt für Einwegprodukte und wieder verwendbare gewebte Materialien und Vlies-stoffe, die als Operationstücher und andere Abdeckungen zum Schutz des Patienten mit dem Anspruch auf Laserstrahlungsbeständigkeit verwendet werden. Der Zweck dieser Internationalen Norm ist, ein genormtes Verfahren zur Prüfung und Einstufung von Operationsabdecktüchern und anderen Abdeckungen zum Schutz des Patienten hinsichtlich der durch Laser hervor gerufenen Gefährdungen zur Verfügung zu stellen. Ein geeignetes Einstufungssystem wird angegeben. Der Zweck dieser Internationalen Norm besteht nicht darin, als allgemeine Brandsicherheits¬vorschrift zu dienen, und insofern werden andere Zündquellen von dieser Norm nicht erfasst.
Alle Materialien reflektieren Anteile des Strahls, und es ist für den Anwender erforderlich, zu entscheiden, ob die spiegelnde Reflexion eine Gefährdung darstellen kann. Diese Messungen werden jedoch in dieser Internationalen Norm nicht erfasst.
Das Prüfverfahren kann genutzt werden, um durch Laser hervorgerufene Entflammbarkeitseigenschaften von nicht-laserresistenten Materialien zu bewerten.
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 besser bei der Wellenlänge geprüft werden sollte, für die ihr Einsatz vorgesehen ist. Bei Prüfung unter Anwendung anderer Wellenlängen sind die Leistungswerte und Anregungsarten explizit anzugeben.
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 - Inflammation principale, pénétration et inflammation secondaire (ISO 11810:2015)
Laserji in z laserji povezana oprema - Preskusna metoda in klasifikacija za ugotavljanje odpornosti proti laserju za operacijska pokrivala in/ali za varovalna pokrivala za paciente - Primarno zgorevanje, prodiranje, širjenje plamena in sekundarno zgorevanje (ISO 11810:2015)
Ta mednarodni standard velja za materiale za enkratno in večkratno uporabo ter tudi za tkane in netkane materiale, ki se uporabljajo kot operacijska pokrivala in druga varovalna pokrivala za paciente, ki naj bi bila odporna proti laserju. Namen tega mednarodnega standarda je zagotoviti standardizirano metodo za preskušanje in klasificiranje operacijskih pokrival in drugih varovalnih pokrival za paciente v zvezi z nevarnostmi, ki jih predstavlja laser.
Podan je primeren sistem klasifikacije. Tega mednarodnega standarda se ne sme uporabljati kot splošne specifikacije na področju požarne varnosti, in kot takšen ne zajema drugih virov vžiga.
Vsi materiali zrcalijo dele žarka, zato se mora uporabnik odločiti, ali lahko refleksijska odbojnost predstavlja nevarnost. Vendar ta meritev ni zajeta v tem mednarodnem standardu.
Za oceno lastnosti gorljivosti, ki jo povzroči laser pri elementih, ki niso odporni proti laserju, je mogoče uporabiti preskusni
postopek.
OPOMBA: Uporabniki izdelkov, ki so bili preskušeni s to metodo, morajo upoštevati, da je odpornost proti laserju operacijskega pokrivala
in/ali varovalnega pokrivala za paciente občutljiva na valovno dolžino, pri čemer je priporočljivo operacijsko pokrivalo in/ali varovalno pokrivalo za paciente preskusiti pri valovni dolžini, pri kateri se bo uporabljalo. Če se preskus izvede pri drugih valovnih dolžinah, je treba izrecno navesti nastavitve moči in načine izvedbe.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2016
1DGRPHãþD
SIST EN ISO 11810-1:2009
SIST EN ISO 11810-2:2009
Laserji in z laserji povezana oprema - Preskusna metoda in klasifikacija za
ugotavljanje odpornosti proti laserju za operacijska pokrivala in/ali za varovalna
pokrivala za paciente - Primarno zgorevanje, prodiranje, širjenje plamena in
sekundarno zgorevanje (ISO 11810:2015)
Lasers and laser-related equipment - Test method and classification for the laser
resistance of surgical drapes and/or patient protective covers - Primary ignition,
penetration, flame spread and secondary ignition (ISO 11810:2015)
Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von
Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Primäre
Entzündung, Laserdurchstrahlung und sekundäre Entzündung (ISO 11810:2015)
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 - Inflammation principale, pénétration et inflammation secondaire (ISO
11810:2015)
Ta slovenski standard je istoveten z: EN ISO 11810:2015
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11810
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.30; 13.340.99; 31.260 Supersedes EN ISO 11810-1:2009, EN ISO 11810-
2:2009
English Version
Lasers and laser-related equipment - Test method and
classification for the laser resistance of surgical drapes
and/or patient protective covers - Primary ignition,
penetration, flame spread and secondary ignition (ISO
11810:2015)
Lasers et équipements associés aux lasers - Méthode Laser und Laseranlagen - Prüfverfahren und
d'essai et classification de la résistance au laser pour Einstufung zur Laserresistenz von Operationstüchern
des draps chirurgicaux et/ou des couvertures de und/oder anderen Abdeckungen zum Schutz des
protection des patients - Inflammation principale, Patienten - Primäre Entzündung, Laserdurchstrahlung
pénétration et inflammation secondaire (ISO und sekundäre Entzündung (ISO 11810:2015)
11810:2015)
This European Standard was approved by CEN on 24 October 2015.
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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11810:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4
European foreword
This document (EN ISO 11810:2015) 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
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 11810-2:2009, EN ISO 11810-1:2009.
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 11810:2015 has been approved by CEN as EN ISO 11810:2015 without any modification.
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 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/Notes
of this EN (ERs)
of Directive 93/42/EEC
The entire standard 7.1(first indent only) This standard is intended to
provide a test method that will
The entire standard 9.3
allow an evaluation of the risk
The entire standard 12.7.5 of laser induced flammability
and temperature increase
associated with the use of a
surgical drapes during laser
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.
INTERNATIONAL ISO
STANDARD 11810
Second edition
2015-12-15
Lasers and laser-related equipment —
Test method and classification for the
laser resistance of surgical drapes
and/or patient protective covers —
Primary ignition, penetration, flame
spread and 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 — Inflammation
principale, pénétration et inflammation secondaire
Reference number
ISO 11810:2015(E)
©
ISO 2015
ISO 11810:2015(E)
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
ISO 11810:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 3
5 Significance and use of the test. 3
6 Apparatus . 4
6.1 General . 4
6.2 Containment box . 5
6.3 Specimen holder . 5
6.4 Laser system . 9
6.4.1 Laser . 9
6.4.2 Power meter . 9
6.5 Gas supply system . 9
6.6 Environment . 9
6.6.1 Ambient air conditions . 9
6.6.2 Oxygen enriched atmospheres . 9
6.7 Smoke evacuation device .10
7 Reagents and materials .10
8 Preparation of specimens .10
8.1 Sampling .10
8.1.1 Single use products .10
8.1.2 Reusable products .10
8.2 Specimens .10
8.3 Quantities .10
8.4 Co
...
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