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    BS-EN-ISO-11810-2-2007.pdf

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    BS-EN-ISO-11810-2-2007.pdf

    BRITISH STANDARD BS EN ISO 11810-2:2007 Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Part 2: Secondary ignition The European Standard EN ISO 11810-2:2007 has the status of a British Standard ICS 11.040.30; 13.340.99; 31.260 ? Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 11810-2:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 June 2007 © BSI 2007 ISBN 978 0 580 53013 5 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 11810-2:2007. Together with BS EN ISO 11810-1:2005 it supersedes BS EN ISO 11810:2002 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CPW/172, Optics and photonics. A list of organizations represented on 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. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 11810-2 May 2007 ICS 11.040.30; 31.260; 13.340.99Supersedes EN ISO 11810:2002 English Version Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007) 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 - Partie 2: Inflammation secondaire (ISO 11810- 2:2007) Laser und Laseranlagen - Prüfverfahren und Einstufung zur Laserresistenz von Operationstüchern und/oder anderen Abdeckungen zum Schutz des Patienten - Teil 2: Sekundäre Entzündung (ISO 11810-2:2007) This European Standard was approved by CEN on 26 April 2007. 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 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 Management Centre has the same status as the official 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, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11810-2:2007: E Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 11810-2:2007) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ 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 November 2007, and conflicting national standards shall be withdrawn at the latest by November 2007. This document supersedes EN ISO 11810:2002. 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(s). For relationship with EU Directive(s), 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, 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. Endorsement notice The text of ISO 11810-2:2007 has been approved by CEN as EN ISO 11810-2:2007 without any modifications. EN ISO 11810-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 11810-2:2007(E) INTERNATIONAL STANDARD ISO 11810-2 First edition 2007-05-01 Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Part 2: 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 Partie 2: Inflammation secondaire EN ISO 11810-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents 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 4.2.3 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 EN ISO 11810-2:2007 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC .12 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iv Foreword 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 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 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 committees 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 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. 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 this part of ISO 11810 the CEN annex regarding fulfilment of European Council Directives will be removed at publication stage. EN ISO 11810-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI v Introduction 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 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 risks 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 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. CO2 lasers may provide the most challenging conditions 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 CO2 laser (continuous wave) has been selected as the laser to be used for 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 manufacturer 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 where 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 surgical 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 combination rather than individually. EN ISO 11810-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 1 Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/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 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. This 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 part 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 CO2 laser (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 modes of delivery need to be explicitly stated. 2 Normative references The following referenced documents are indispensable for the application of this document. 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 symbols 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 ISO 11810-1, 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 EN ISO 11810-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:40 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 2 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11145, ISO 11810-1 and the following apply. 3.1 secondary ignition ignition of a test sample by an underlying material caused to burn by a laser beam transmitted through the sample 4 Test methods 4.1 General conditions The suggested testing sequence is shown in Figure 1. 4.1.1 Sampling 4.1.1.1 Single-use products Single-use products shall be obtained directly from the packing in which the products are sold. 4.1.1.2 Re-usable products Re-usable products shall be te

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