1、BSI Standards PublicationBS EN ISO 11810:2015Lasers and laser-relatedequipment Test methodand classification for the laserresistance of surgical drapesand/or patient protectivecovers Primary ignition,penetration, flame spread andsecondary ignitionBS EN ISO 11810:2015 BRITISH STANDARDNational forewor
2、dThis British Standard is the UK implementation of EN ISO 11810:2015. It supersedes BS EN ISO 11810-2:2009 and BS EN ISO 11810-1:2009 which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CPW/172, Optics and Photonics.A list of organizations represented on
3、this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 86020 1
4、ICS 11.040.30; 13.340.99; 31.260 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate T e x t a f f
5、 e c t e dEUROPEAN 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 resistance of surgical drapes a
6、nd/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 protection des patients - Infl
7、ammation 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 Entzndung (ISO 11810:2015
8、) 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 r
9、eferences 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
10、 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 Maced
11、onia, 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 NORMALISATION EUROP
12、ISCHES 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 EBS EN ISO 11810:2015EN ISO 11810:2015 (E) 3 European foreword This docu
13、ment (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
14、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 s
15、hall 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 requi
16、rements 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
17、, 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,
18、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. BS EN ISO 11810:2015EN ISO 11810:2015 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requireme
19、nts 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 stan
20、dard 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 c
21、onformity 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) of Directive 93/42/EEC Qualifying remarks/Notes
22、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 flammability and temperature increase associated with the use of a surgical drapes during laser surgery as part of the risk assessment as set out i
23、n 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 product(s) falling within the scope of this standard. BS EN ISO 11810:2015ISO 11810:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative re
24、ferences 13 Terms and definitions . 14 Principle 35 Significance and use of the test 36 Apparatus . 46.1 General . 46.2 Containment box . 56.3 Specimen holder 56.4 Laser system . 96.4.1 Laser . 96.4.2 Power meter 96.5 Gas supply system 96.6 Environment . 96.6.1 Ambient air conditions . 96.6.2 Oxygen
25、 enriched atmospheres 96.7 Smoke evacuation device 107 Reagents and materials 108 Preparation of specimens 108.1 Sampling 108.1.1 Single use products .108.1.2 Reusable products .108.2 Specimens 108.3 Quantities . 108.4 Conditioning . 109 Preparation of apparatus .1110 Test methods 1110.1 General con
26、ditions 1110.2 Primary ignition and penetration 1110.2.1 Principle . 1110.2.2 Testing procedure 1410.3 Secondary ignition 1510.3.1 Principle . 1510.3.2 Testing procedure 1611 Classification .1811.1 General 1811.2 Laser-induced primary ignition (I) 1811.3 Resistance to laser penetration (P) 1811.4 La
27、ser-induced secondary ignition (SI) 1812 Test report 19Bibliography .20 ISO 2015 All rights reserved iiiContents PageBS EN ISO 11810:2015ISO 11810:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The w
28、ork 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-govern
29、mental, 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.The procedures used to develop this document and those intended for its further maintenance are described in t
30、he ISO/IEC Directives, Part 1. In particular the different approval criteria 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 poss
31、ibility 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list o
32、f patent declarations received (see www.iso.org/patents).Any trade name used 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
33、information about ISOs adherence to the WTO principles in the Technical Barriers 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 c
34、ancels and replaces ISO 11810-1:2005 and ISO 11810-2:2007 which have been technically revised.iv ISO 2015 All rights reservedBS EN ISO 11810:2015ISO 11810:2015(E)IntroductionSome laser applications in medicine can require laser-resistant surgical drapes or other patient-protective covers. Surgical d
35、rapes 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-resist
36、ant, specifically designed surgical drapes offer the possibility of laser resistance.Laser induced 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 the
37、re 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 International Standard is intended for use in testing a surgical drape or other pa
38、tient-protective cover that claims to be laser-resistant. In addition, areas within this product 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.CO2las
39、ers can induce the most challenging conditions of all medical lasers. Ignition/flammability tests 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 sele
40、cted as the laser for this International Standard.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 other patient-protective cover should be tested at the wavelengths for w
41、hich it is intended to be used. If tested using other wavelengths, it is necessary to explicitly 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 dra
42、pes or other patient-protective covers can be changed when used in combination rather than individually. ISO 2015 All rights reserved vBS EN ISO 11810:2015BS EN ISO 11810:2015Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient
43、protective covers Primary ignition, penetration, flame spread and secondary ignitionCAUTION This test method can involve hazardous materials, operations and equipment. This International Standard provides advice on minimizing some of the risks associated with its use but does not purport to address
44、all such risks. It is the responsibility of the user of this International Standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.1 ScopeThis International Standard is applicable to disposable and reusable, as well as w
45、oven 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 l
46、aser-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
47、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 itemsNOTE Users of products tested b
48、y 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,
49、 it is necessary to explicitly state the power settings and modes of delivery.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11145, Optics and photonics Lasers and laser-related equipment Vocabulary and symbolsISO 11146-1, Lasers and laser-related equipment Test methods for
