ISO 11810-2-2007 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and or patient-protective cover.pdf

1、 Reference numberISO 11810-2:2007(E)ISO 2007INTERNATIONAL STANDARD ISO11810-2First edition2007-05-01Lasers 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 quipements associs a

2、ux lasers Mthode dessai et classification de la rsistance au laser pour des draps chirurgicaux et/ou des couvertures de protection des patients Partie 2: Inflammation secondaire Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduct

3、ion or networking permitted without license from IHS-,-,-ISO 11810-2:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and

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6、und, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 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 mi

7、crofilm, 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

8、 2007 All rights reservedCopyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-2:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 S

9、cope . 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 Las

10、er-induced secondary ignition of test material .9 5.2 Classification definition . 9 6 Test Report 10 Bibliography . 11 Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-IS

11、O 11810-2:2007(E) iv ISO 2007 All rights reservedForeword 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

12、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

13、 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

14、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

15、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

16、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 D

17、irectives will be removed at publication stage. Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-2:2007(E) ISO 2007 All rights reserved vIntroduction Some laser

18、 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 las

19、er 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 reflectivi

20、ty. 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

21、 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. CO2lasers may provide the most challenging conditions of all medical lasers. Ignition/inflammability tests and penetration tests may di

22、sclose 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 to be used for this part of ISO 11810. For laser-induced secondary ignition of drapes and/or patient prote

23、ctive 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 p

24、art 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

25、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

26、 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. Copyright International Organization for Standardization Provi

27、ded by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-INTE

28、RNATIONAL STANDARD ISO 11810-2:2007(E) ISO 2007 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 2: Secondary ignition 1 Scope This part of ISO 11810 is applicable to disposable an

29、d 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 wit

30、h 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.

31、 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 forma

32、ts. The 20 W CO2laser (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 drap

33、e 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 app

34、lication 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

35、 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 protectiv

36、e covers Part 1: Primary ignition and penetration Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-2:2007(E) 2 ISO 2007 All rights reserved3 Terms and definitio

37、ns 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

38、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 tested new and after reprocessing to the point when their

39、 rating changes. Reprocessing shall include laundering, decontaminating and, if necessary, sterilization in accordance with the manufacturers recommendations. The point at which the product rating degrades shall be the maximum allowed number of uses as determined by the manufacturer. 4.1.1.3 Specime

40、ns The samples are 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 Quantities For each parameter to be measured, five specimens shall be tested. 4.1.1.5 Conditioning Al

41、l materials (specimens, cotton gauze, and white mercerized cotton thread) 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 use. Any special treatment or

42、preparation shall be stated when reporting results. NOTE These conditions have been chosen in accordance with 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 draught-resistant ventilated c

43、hamber, specimen holder, specimen rack, laser energy source and associated parts (see Figures 2 and 3). Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-2:2007(

44、E) ISO 2007 All rights reserved 3Key 1, 2 Ignition classification according to ISO 11810-1 S1 Secondary ignition class 1 S2 Secondary ignition class 2 S3 Secondary ignition class 3 Indices 21, 60, 95: Amount of oxygen in percent Oxy Oxygen Figure 1 Suggested testing sequence for secondary ignition t

45、esting Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-2:2007(E) 4 ISO 2007 All rights reservedDimensions in millimetres Key 1 test chamber 2 specimen holder 3

46、 laser Figure 2 Test chamber Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO 11810-2:2007(E) ISO 2007 All rights reserved 5Key 1 top frame 4 cotton gauze 2 sample 5

47、bottom frame 3 mount 6 hinge aElements are connected. Figure 3 Example of a specimen holder 4.1.2.2 Test chamber The test chamber shall be constructed of a corrosion-resistant and laser and fireproof material. It shall be a box with minimum dimensions of 365 mm length by 215 mm depth by 355 mm heigh

48、t 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 have a hole for the laser transmission system. The test chamber shall be connected to 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 holder at a 45 angle to the bottom of the chamber. Measures shall be taken to ensure