EN ISO 11810-2-2009 7500 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and or patient-protective covers - Part 2 S.pdf

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1、BS EN ISO11810-2:2009ICS 11.040.30; 13.340.99; 31.260NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDLasers and laser-related equipment Test method andclassification for thelaser-resistance ofsurgical drapes and/or patient-protectivecoversPart 2: Secondary ignit

2、ion (ISO11810-2:2007)Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30Novem

3、ber 2009. BSI 2009ISBN 978 0 580 65203 5Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 11810-2:2009National forewordThis British Standard is the UK implementation of EN ISO11810-2:2009. It is identical to ISO 11810-2:2007. It supersedes BS ENISO 11810-2:2007 which is withdrawn.

4、The UK participation in its preparation was entrusted to TechnicalCommittee CPW/172/9, Electro-optical systems.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. User

5、s are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EURO

6、PEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11810-2March 2009ICS 13.340.99; 31.260; 11.040.30 Supersedes EN ISO 11810-2:2007 English VersionLasers and laser-related equipment - Test method andclassification for the laser-resistance of surgical drapes and/orpatient-protective covers - Part 2: S

7、econdary ignition (ISO11810-2:2007)Lasers et quipements associs aux lasers - Mthodedessai et classification de la rsistance au laser pour desdraps chirurgicaux et/ou des couvertures de protection despatients - Partie 2: Inflammation secondaire (ISO 11810-2:2007)Laser und Laseranlagen - Prfverfahren

8、und Einstufung zurLaserresistenz von Operationstchern und/oder anderenAbdeckungen zum Schutz des Patienten - Teil 2:Sekundre Entzndung (ISO 11810-2:2007)This European Standard was approved by CEN on 26 January 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipu

9、late the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exi

10、sts in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bod

11、ies 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.EUROP

12、EAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11810-2:2009: ECopyright Europ

13、ean Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11810-2:2009EN ISO 11810-2:2009 (E) 3 Foreword The text of ISO 11810-2:2007 has been prepared by Technical Committee ISO/TC 172 “Optics

14、 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 standa

15、rd, 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.

16、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 requir

17、ements 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,

18、 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 n

19、otice The text of ISO 11810-2:2007 has been approved by CEN as a EN ISO 11810-2:2009 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11810-2:2

20、009EN ISO 11810-2:2009 (E) 4 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

21、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 wi

22、th 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 Standar

23、d and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 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 ma

24、y be applicable to the product(s) falling within the scope of this standard. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11810-2:2009ISO 11810-2:2007(E) ISO 2007 Al

25、l rights reserved iiiContents 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

26、.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 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction

27、 or networking permitted without license from IHS-,-,-BS EN ISO 11810-2:2009ISO 11810-2:2007(E) iv ISO 2007 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internati

28、onal 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 IS

29、O, 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 co

30、mmittees 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

31、 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.

32、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 t

33、his part of ISO 11810 the CEN annex regarding fulfilment of European Council Directives will be removed at publication stage. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS E

34、N ISO 11810-2:2009ISO 11810-2:2007(E) ISO 2007 All rights reserved vIntroduction 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

35、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 ri

36、sks 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

37、 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. CO2lasers may provide the most challenging c

38、onditions of all medical lasers. Ignition/inflammability tests and 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 CO2laser (continuous wave) has been selected as the laser to be used for

39、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 manufa

40、cturer 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 wh

41、ere 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 surgi

42、cal 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 combinati

43、on rather than individually. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11810-2:2009Copyright European Committee for Standardization Provided by IHS under license

44、with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11810-2:2009INTERNATIONAL STANDARD ISO 11810-2:2007(E) ISO 2007 All rights reserved 1Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/

45、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

46、 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. Thi

47、s 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 p

48、art 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 CO2laser (continuous wave) has been selected as the laser to be used for this part of ISO 11810. 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, the power settings and