EN ISO 11810-1-2009 1875 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and or patient protective covers - Part 1 P.pdf

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1、BS EN ISO11810-1:2009ICS 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 1: Primary ignitio

2、n andpenetration (ISO 11810-1:2005)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 Commit

3、tee on 30November 2009. BSI 2009ISBN 978 0 580 65614 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 11810-1:2009National forewordThis British Standard is the UK implementation of EN ISO11810-1:2009. It is identical to ISO 11810-1:2005. It supersedes BS ENISO 11810-1:2005 which

4、 is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CPW/172/9, Electro-optical systems.A list of organizations represented on this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

5、contract. Users 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 fro

6、m IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11810-1April 2009ICS 11.040.30; 13.340.99; 31.260 Supersedes EN ISO 11810-1:2005 English VersionLasers and laser-related equipment - Test method andclassification for the laser resistance of surgical drapes and/orpatient protective cove

7、rs - Part 1: Primary ignition andpenetration (ISO 11810-1:2005)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 1: Inflammation primaire et pntration(ISO 11810-1:2005)

8、Laser und Laseranlagen - Prfverfahren und Einstufung zurLaserresistenz von Operationstchern und/oder anderenAbdeckungen zum Schutz des Patienten - Teil 1: PrimreEntzndung und Laserdurchstrahlung (ISO 11810-1:2005)This European Standard was approved by CEN on 21 March 2009.CEN members are bound to co

9、mply with the CEN/CENELEC Internal Regulations which stipulate 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 Managem

10、ent 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theof

11、ficial 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, Slo

12、venia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN 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 natio

13、nal Members.Ref. No. EN ISO 11810-1:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11810-1:2009EN ISO 11810-1:2009 (E) 3 Foreword The text of ISO 11810-1:2005 h

14、as 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 11810-1:2009 by Technical Committee CEN/TC 123 “Lasers and photonics” the secretariat of which is held by DIN. This Europe

15、an Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the element

16、s 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 11810-1:2005. This document has been prepared under a mandate given to CEN by the European Commission and the Europe

17、an 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

18、 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, S

19、weden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11810-1:2005 has been approved by CEN as a EN ISO 11810-1:2009 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking pe

20、rmitted without license from IHS-,-,-BS EN ISO 11810-1:2009EN ISO 11810-1:2009 (E) 4 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 Commi

21、ssion 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 nati

22、onal 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

23、. Table ZA.1 Correspondence between this European Standard 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 This entire standard 1; 2; 3; 4; 7.1; 9.3; 12.7.5; 13.1 Only the test method and the classification sy

24、stem WARNING Other requirements and other EU Directives may 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

25、-,-,-BS EN ISO 11810-1:2009ISO 11810-1:2005(E) ISO 2005 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Test methods. 3 4.1 General conditions 3 4.2 Testing procedure. 7 5 Classification. 8 5.1 Laser induced ignition (

26、) . 8 5.2 Resistance to laser penetration (P). 9 5.3 Classification definition 9 6 Test report 9 Bibliography . 11 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

27、-1:2009ISO 11810-1:2005(E) iv ISO 2005 All rights reservedForeword 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 committe

28、es. 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 Inte

29、rnational 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 S

30、tandards 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 su

31、bject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11810-1 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 9, Electro-optical systems. This first edition cancels and replaces ISO 11810:2002, which has bee

32、n technically revised. 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 ignitio

33、n 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 11810-1:2009ISO 11810-1:2005(E) ISO 2005 All rights reserved vIntroduction Some laser applications in medicine may req

34、uire 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

35、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, flammability, melting, penetration, thermal transfer and reflectivity. Textile and non-woven drape mat

36、erials 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), this test method addresses only the laser ignition source. This part of

37、 ISO 11810 is intended for use in testing a surgical drape or other patient protective cover that claims to be laser-resistant. In addition, areas within this product may vary in material composition or design. Depending on the claims being made by the manufacturer or end-user requirements, all area

38、s for which laser resistance is claimed may need to be tested. CO2lasers may provide the most challenging conditions of all medical lasers. Ignition/flammability tests and penetration tests may disclose more challenging laser wavelengths as well as modes of laser delivery, for example Q-switching in

39、 the nanosecond range. The 20 W CO2laser (continuous wave) has been selected as the laser for this part of ISO 11810. Users of this test method are cautioned that the laser resistance of a surgical drape or other patient protective cover will be wavelength sensitive and that a surgical drape or othe

40、r protective cover should be tested at the wavelengths for which it is intended to be used. If tested using other wavelengths, the power settings and modes of delivery need to be explicitly stated. The results from this part of ISO 11810 should not be applied to other wavelengths and temporal format

41、s. The performance of laser-resistant surgical drapes or other patient protective covers may be changed when used in combination rather than individually. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted with

42、out license from IHS-,-,-BS EN ISO 11810-1:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11810-1:2009INTERNATIONAL STANDARD ISO 11810-1:2005(E) ISO 2005 All right

43、s reserved 1Lasers 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 1 Scope This part of ISO 11810 is applicable to disposable and reusable, as well as woven and non-woven

44、materials used as surgical drapes and other 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 other patient protective covers with respect to laser-induced hazards. An

45、 appropriate classification system is given. It is not the purpose of this part of ISO 11810 to serve as a general fire safety specification, and as such, this part of ISO 11810 does not cover other sources of ignition. It also does not cover the issue of laser-induced secondary ignition. All materi

46、als reflect portions of the beam and it is necessary for the user to decide whether specular reflectance may be a hazard. This measurement, however, is not covered in this part of ISO 11810. 2 Normative references The following referenced documents are indispensable for the application of this docum

47、ent. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11145:2001, Optics and optical instruments Lasers and laser-related equipment Vocabulary and symbols ISO 11146-1, Lasers and laser-

48、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 afterflame persistence of flaming of a material, under specified test conditions, after the ignition source has been removed 3.2 afterflame time length of time for which a material continues to flame, under specified test conditions, after the ignition source has been removed Copyright European Committee for Standardiza