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1、BRITISH STANDARD BS EN ISO 11810-1:2005 Incorporating corrigendum no. 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 The European Standard EN ISO 11810-1:2005 ha
2、s 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, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 11810-1:2005 This British Standard was published under the authority of the Standa
3、rds Policy and Strategy Committee on 15 March 2005 BSI 2007 ISBN 978 0 580 59282 9 National foreword This British Standard is the official English language version of EN ISO 11810-1:2005. It is identical with ISO 11810-1:2005. Together with BS EN ISO 11810-2:2007 it supersedes BS EN ISO 11810:2002 w
4、hich is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CPW/172, Optics and optical instruments, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British St
5、andards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. T
6、his 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 does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible in
7、ternational/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the E
8、N ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 11 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 17236 Corrigendum No
9、. 1 29 June 2007Revision of supersession information Licensed Copy: London South Bank University, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11810-1 February 2005 ICS 31.260; 13.340.99; 11.040.
10、30 Supersedes 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 1: Primary ignition and penetration (ISO 11810-1:2005) Lasers et quipements associs aux lasers - Mth
11、ode dessai et classification de la rsistance au laser pour des draps chirurgicaux et/ou des couvertures de protection des patients - Partie 1: Allumage primaire et pntration (ISO 11810-1:2005) Laser und Laseranlagen - Prfverfahren und Einstufung zur Laserresistenz von Operationstchern und/oder ander
12、en Abdeckungen zum Schutz des Patienten - Teil 1: Primre Entzndung und Laserdurchstrahlung (ISO 11810-1:2005) This European Standard was approved by CEN on 7 February 2005. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europe
13、an 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 Central Secretariat or to any CEN member. This European Standard exists in three official versions (English,
14、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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech R
15、epublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMA
16、LISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11810-1:2005: E Licensed Copy: London South Bank University, London South Bank
17、University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI I NESO 11-018:1002( 5E) 2 Foreword This document (EN ISO 11810-1:2005) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ in collaboration with Technical Committee CEN/TC 123 “Lasers and phot
18、onics“, 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 August 2005, and conflicting national standards shall be withdrawn at the latest by August 2005. Th
19、is document supersedes EN ISO 11810:2002. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hu
20、ngary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11810-1:2005 has been approved by CEN as EN ISO 11810-1:2005 without any modifications. E
21、N ISO 118101:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 11810-1:2005(E) OSI 5002 INTERNATIONAL STANDARD ISO 11810-1 First edition 2005-02-15 Lasers and laser-related equipment Tes
22、t method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and penetration 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
23、ection des patients Partie 1: Allumage primaire et pntration EN ISO 118101:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI IS-01811 O1:(5002E) DPlcsid Fremia ihTs PDF file may ctnoian emdebt dedyfepcaes. I
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28、eG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mail coirypthgiso.o gr We bwww.is.o gro Pulbisdehi n Switlrez dna ii ISO 5002 Allr ithgsr esedevr EN ISO 118101:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontr
29、olled Copy, (c) BSI IS-01811 O1:(5002E) I SO 5002 All irthgs ersedevr iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Test methods.3 4.1 General conditions3 4.2 Testing procedure.7 5 Classification.8 5.1 Laser induced ignition ( ).8 5.2 Resi
30、stance to laser penetration (P).9 5.3 Classification definition9 6 Test report9 Bibliography .11 EN ISO 118101:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI IS-01811 O1:(5002E) iv I SO 5002 All irthgs er
31、sedevr 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 wh
32、ich 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
33、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 ci
34、rculated 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 respo
35、nsible 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 been technically revised. ISO 11810 consists of the fo
36、llowing 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 EN ISO 118101:2005 Licensed Copy: London South Ba
37、nk University, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI IS-01811 O1:(5002E) I SO 5002 All irthgs ersedevr v Introduction Some laser applications in medicine may require laser-resistant surgical drapes or other patient protective covers. Surgical dr
38、apes 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
39、ant, 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 materials may have other risks but they may provide a laser barrier. While there are m
40、any 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 ISO 11810 is intended for use in testing a surgical drape or other patient protec
41、tive 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 areas for which laser resistance is claimed may need to be tested. CO2 lasers may prov
42、ide 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 the nanosecond range. The 20 W CO2 laser (continuous wave) has been selected as
43、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 other protective cover should be tested at the wavelengths for which it is intended
44、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 formats. The performance of laser-resistant surgical drapes or other patient protectiv
45、e covers may be changed when used in combination rather than individually. EN ISO 118101:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI blank EN ISO 118101:2005 Licensed Copy: London South Bank University
46、, London South Bank University, Tue Jul 03 01:05:29 GMT+00:00 2007, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS-01811 O1:(5002E) I SO 5002 All irthgs ersedevr 1 Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient prote
47、ctive 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 materials used as surgical drapes and other patient protective covers which claim to be laser-resistant. The purpose of this part of ISO 11810
48、 is to provide a standardized method for testing and classifying surgical drapes and other 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,
49、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 materials 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