1、 Reference numberISO 11810-1:2005(E)ISO 2005INTERNATIONAL STANDARD ISO11810-1First edition2005-02-15Lasers 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 Lasers et quipem
2、ents associs aux lasers Mthode 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 Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not
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6、em relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfil
7、m, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005
8、All rights reservedCopyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-1:2005(E) ISO 2005 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope
9、 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 () . 8 5.2 Resistance to laser penetration (P). 9 5.3 Classification definition 9 6 Test report 9 Bibliography . 11 Copyright In
10、ternational Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-1:2005(E) iv ISO 2005 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide
11、 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
12、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 acc
13、ordance 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 requ
14、ires 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 11810-1 was prepared by Techn
15、ical 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 following parts, under the general title Lasers and laser-related equipment Test method a
16、nd classification for the laser resistance of surgical drapes and/or patient protective covers: Part 1: Primary ignition and penetration Part 2: Secondary ignition Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or netwo
17、rking permitted without license from IHS-,-,-ISO 11810-1:2005(E) ISO 2005 All rights reserved vIntroduction 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 ster
18、ile 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 r
19、esistance. 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 many potential ignition devices present in the operating room (e.g.
20、 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 protective cover that claims to be laser-resistant. In addition, areas wi
21、thin 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. CO2lasers may provide the most challenging conditions of all medical lasers. Ignition/
22、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 CO2laser (continuous wave) has been selected as the laser for this part of ISO 11810. Users of this test method are c
23、autioned 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 to be used. If tested using other wavelengths, the power settings and
24、 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 protective covers may be changed when used in combination rather than individu
25、ally. Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleN
26、o reproduction or networking permitted without license from IHS-,-,-INTERNATIONAL STANDARD ISO 11810-1:2005(E) ISO 2005 All rights 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
27、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 is to provide a standardized
28、 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, and as such, this part of ISO
29、 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
30、 part of ISO 11810. 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 11
31、145:2001, Optics and optical instruments 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 3 Terms and definitions F
32、or 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 te
33、st conditions, after the ignition source has been removed Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-1:2005(E) 2 ISO 2005 All rights reserved3.3 aftergl
34、ow persistence of glowing of a material, under specified test conditions, after cessation of flaming or, if no flaming occurs, after the ignition source has been removed 3.4 afterglow time time during which a material continues to glow, under specified test conditions, after cessation of flaming or,
35、 if no flaming occurs, after the ignition source has been removed 3.5 combustion any continuing burning process that occurs on the test sample 3.6 flammable subject to ignition and flaming combustion 3.7 ignition initiation of combustion 3.8 melting behaviour softening of a material under the influe
36、nce of heat (including shrinking, dripping and burning of molten material, etc.) 3.9 patient protective cover material, other than a surgical drape, intended to protect a patient 3.10 penetration resistance ability of a material to prevent the passage of laser energy 3.11 product finished medical de
37、vice (drape or other patient cover) that may be composed of one or more homogeneous materials (samples) 3.12 reusable product product intended to be laundered and re-sterilized for multiple use 3.13 single use product intended to be used once and then discarded 3.14 surgical drape material intended
38、to be draped over a patient during surgery 3.15 thermal resistance ability of a material to resist conduction of heat Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-I
39、SO 11810-1:2005(E) ISO 2005 All rights reserved 34 Test methods 4.1 General conditions The suggested testing sequence for ignition is shown in Figure 1. The suggested testing sequence for penetration is shown in Figure 2. Figure 1 Suggested testing sequence for ignition Copyright International Organ
40、ization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-1:2005(E) 4 ISO 2005 All rights reservedFigure 2 Suggested testing sequence for penetration 4.1.1 Sampling 4.1.1.1 Single-use products Sin
41、gle use products shall be obtained directly from the packing in which the products are sold. Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-1:2005(E) ISO 20
42、05 All rights reserved 54.1.1.2 Reusable products Reusable products shall be tested new and after reprocessing to the point when their rating changes. Reprocessing shall include laundering, decontaminating and, if necessary, sterilization in accordance with the manufacturers recommendations. The poi
43、nt at which the product rating degrades shall be the maximum allowed number of uses. 4.1.1.3 Specimens The sample is cut into specimens of at least 150 mm in length by at least 50 mm in width, with the faster burning direction (as determined by preliminary testing) in the long direction. 4.1.1.4 Qua
44、ntities For each parameter to be measured, 5 specimens shall be tested. 4.1.1.5 Conditioning Specimens shall be conditioned for 24 h at 20 C 2 C and 65 % 2 % relative humidity. Materials requiring special treatment or preparation shall be conditioned according to the manufacturers instructions for u
45、se. Any special treatment or preparation shall be stated when reporting results. NOTE These conditions have been chosen according to ISO 139:2005 to ensure standard test results and simulate operating room conditions. 4.1.2 Test equipment 4.1.2.1 General The test apparatus shall consist of a draft-r
46、esistant ventilated chamber (required for the laser-induced flammability tests, optional for other parameters), specimen holder, specimen rack, laser energy source and associated parts (see Figures 3 and 4). 4.1.2.2 Test chamber The test chamber shall be constructed of a corrosion-resistant and lase
47、r and fireproof material. It shall be a box with minimum dimensions of 365 mm length by 215 mm depth by 355 mm height with ventilation openings at the top and a door at one side. At least one side of the chamber shall have a glass window for observation during testing. One side of the chamber shall
48、have a hole for the laser transmission system. The test chamber shall be connected with the gas supply system in such a way that homogeneous ventilation of the chamber is achieved. A specimen rack shall provide support to mount the specimen at a 45 angle to the bottom of the chamber. Measures shall be taken to ensure that no dangerous radiation leaves the chamber. A piece of clean filter paper shall be positioned on the floor of the test chamber directly beneath the test specimen for detection of dropped particles capable of igniting other materials. NOTE The mass of oxygen availab
