DIN EN ISO 11810-2016 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and or patient protective covers - Primary igni.pdf

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1、June 2016 English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.140; 13.340.99; 31.260!%Vus“2518

2、280www.din.deDIN EN ISO 11810Lasers 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);English version EN ISO 11810:2015,English tr

3、anslation of DIN EN ISO 11810:2016-06Laser und Laseranlagen Prfverfahren und Einstufung zur Laserresistenz von Operationstchern und/oder anderen Abdeckungen zum Schutz des Patienten Primre Entzndung, Laserdurchstrahlung und sekundre Entzndung (ISO 11810:2015);Englische Fassung EN ISO 11810:2015,Engl

4、ische bersetzung von DIN EN ISO 11810:2016-06Lasers et quipements associs aux lasers Mthode dessai et classification de la rsistance au laser pour des draps chirurgicaux et/ou des couvertures de protection des patients Inflammation principale, pntration et inflammation secondaire (ISO 11810:2015);Ve

5、rsion anglaise EN ISO 11810:2015,Traduction anglaise de DIN EN ISO 11810:2016-06SupersedesDIN EN ISO 11810-1:2009-07 andDIN EN ISO 11810-2:2009-07www.beuth.deDocument comprises 31 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative

6、.06.16DIN EN ISO 11810:2016-06 2 A comma is used as the decimal marker. National 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” (Secretariat: DIN, German

7、y). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-18 AA Laser. The DIN Standards corresponding to the International Standards referred to in this document ar

8、e as follows: IEC 60825-1 DIN EN 60825-1, VDE 0837-1 ISO 11145 DIN EN ISO 11145 ISO 11146-1 DIN EN ISO 11146-1 ISO 80000-4 DIN EN ISO 80000-4 Amendments This standard differs from DIN EN ISO 11810-1:2009-07 and DIN EN ISO 11810-2:2009-07 as follows: a) Parts 1 and 2 have been combined into one stand

9、ard and the content has been editorially revised; b) the list of characteristics of the containment box has been extended; c) Subclauses 6.5 “Gas supply system”, 6.7 “Smoke evacuation device” and Clause 9 “Preparation of apparatus” have been added. Previous editions DIN EN ISO 11810: 2003-01 DIN EN

10、ISO 11810-1: 2005-05, 2009-07 DIN EN ISO 11810-2: 2007-08, 2009-07 DIN EN ISO 11810:2016-06 3 National Annex NA (informative) Bibliography DIN EN 60825-1 (VDE 0837-1), Safety of laser products Part 1: Equipment classification and requirements DIN EN ISO 11145, Optics and photonics Lasers and laser-r

11、elated equipment Vocabulary and symbols DIN EN 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 DIN EN ISO 80000-4, Quantities and units Part 4: Mechanics DIN EN ISO 11810:2

12、016-06 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11810 December 2015 ICS 11.040.30; 13.340.99; 31.260 Supersedes EN ISO 11810-1:2009, EN ISO 11810-2:2009English Version Lasers and laser-related equipment Test method and classification for the laser r

13、esistance of surgical drapes and/or patient protective covers Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015) Lasers et quipements associs aux lasers Mthode dessai et classification de la rsistance au laser pour des draps chirurgicaux et/ou des couvertures de prot

14、ection des patients Inflammation principale, pntration et inflammation secondaire (ISO 11810:2015) Laser und Laseranlagen Prfverfahren und Einstufung zur Laserresistenz von Operationstchern und/oder anderen Abdeckungen zum Schutz des Patienten Primre Entzndung, Laserdurchstrahlung und sekundre Entzn

15、dung (ISO 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 a

16、nd 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

17、 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 Yugosl

18、av 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 andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE

19、 NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Members. Ref. No. EN ISO 11810:2015 EEN ISO 11810:2015 (E) 2 Contents Page European fore

20、word . 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 5 Foreword 6 Introduction 7 1 Scope 8 2 Normative references 8 3 Terms and definitions . 8 4 Principle 10 5 Significance and use of the test . 10 6 Apparatus 11 6.1 Ge

21、neral . 11 6.2 Containment box 12 6.3 Specimen holder . 12 6.4 Laser system 16 6.4.1 Laser 16 6.4.2 Power meter . 16 6.5 Gas supply system 16 6.6 Environment 16 6.6.1 Ambient air conditions. 16 6.6.2 Oxygen enriched atmospheres 16 6.7 Smoke evacuation device 17 7 Reagents and materials 17 8 Preparat

22、ion of specimens . 17 8.1 Sampling 17 8.1.1 Single use products 17 8.1.2 Reusable products . 17 8.2 Specimens . 17 8.3 Quantities 17 8.4 Conditioning . 17 9 Preparation of apparatus 18 10 Test methods . 18 10.1 General conditions . 18 10.2 Primary ignition and penetration 18 10.2.1 Principle 18 10.2

23、.2 Testing procedure 21 10.3 Secondary ignition . 22 10.3.1 Principle 22 10.3.2 Testing procedure 23 DIN EN ISO 11810:2016-06 EN ISO 11810:2015 (E) 3 11 Classification 25 11.1 General . 25 11.2 Laser-induced primary ignition (I) 25 11.3 Resistance to laser penetration (P) 25 11.4 Laser-induced secon

24、dary ignition (SI) 25 12 Test report 26 Bibliography . 27 DIN EN ISO 11810:2016-06 EN ISO 11810:2015 (E) 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 p

25、hotonics” 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. Atte

26、ntion 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

27、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 Intern

28、al 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, Ire

29、land, 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. DIN

30、EN ISO 11810:2016-06 EN ISO 11810:2015 (E) 5 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 Associ

31、ation 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, co

32、mpliance 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 Standa

33、rd and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes The entire standard 7.1(first indent only) This standard is intended to provide a test method that will allow an evaluation of the risk of laser induced flammabi

34、lity 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. The entire standard 9.3 The entire standard 12.7.5 WARNING Other requirements and other EU Directives may be applicable to the pr

35、oduct(s) falling within the scope of this standard. DIN EN ISO 11810:2016-06 ForewordISO (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

36、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 clo

37、sely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria

38、needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of pate

39、nt rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used

40、in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barri

41、ers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 9, Electro-optical systems.This second edition cancels and replaces ISO 11810-1:2005 and ISO 11810-2:2007 which have been tec

42、hnically revised.EN ISO 11810:2015 (E) DIN EN ISO 11810:2016-06 6IntroductionSome laser applications in medicine can 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

43、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 surgical drapes offer the possibility of laser resistance.Laser induce

44、d risks include ignition, flammability, melting, penetration, thermal transfer and reflectivity. Textile and non-woven drape materials can have other risks but they can provide a laser barrier. While there are many potential ignition devices present in the operating room (e.g. fibre optic illuminati

45、on systems, electro-surgical units, hot wire cauteries), this test method addresses only the laser ignition source. This International Standard 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

46、can vary in material composition or design. Depending on the claims being made by the manufacturer or end-user requirements, all areas for which laser resistance is claimed might need to be tested.CO2lasers can induce the most challenging conditions of all medical lasers. Ignition/flammability tests

47、 and penetration tests can reveal 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 for this International Standard.Users of this test method are cautioned that th

48、e laser resistance of a surgical drape or other patient-protective cover will be wavelength sensitive and that a surgical drape or other patient-protective cover should be tested at the wavelengths for which it is intended to be used. If tested using other wavelengths, it is necessary to explicitly

49、state the power settings and modes of delivery.The results from this International Standard should not be applied to other wavelengths and temporal formats.The performance of laser-resistant surgical drapes or other patient-protective covers can be changed when used in combination rather than individually.EN ISO 11810:2015 (E) DIN EN ISO 11810:2016-06 7 CAUTION This test method can involve hazardous materials, operations and equipment. This International Standard provides advice on minimizing some of the risks ass