1、 TECHNICAL REPORT IEC TR 60825-8Second edition 2006-12Safety of laser products Part 8: Guidelines for the safe use of laser beams on humans Reference number IEC/TR 60825-8:2006(E) Publication numbering As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series. For
2、 example, IEC 34-1 is now referred to as IEC 60034-1. Consolidated editions The IEC is now publishing consolidated versions of its publications. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the base publication incorporating amendment 1 and the base pub
3、lication incorporating amendments 1 and 2. Further information on IEC publications The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content reflects current technology. Information relating to this publication, including its validity, is avai
4、lable in the IEC Catalogue of publications (see below) in addition to new editions, amendments and corrigenda. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepared this publication, as well as the list of publications issued, i
5、s also available from the following: IEC Web Site (www.iec.ch) Catalogue of IEC publications The on-line catalogue on the IEC web site (www.iec.ch/searchpub) enables you to search by a variety of criteria including text searches, technical committees and date of publication. On-line information is a
6、lso available on recently issued publications, withdrawn and replaced publications, as well as corrigenda. IEC Just Published This summary of recently issued publications (www.iec.ch/online_news/ justpub) is also available by email. Please contact the Customer Service Centre (see below) for further
7、information. Customer Service Centre If you have any questions regarding this publication or need further assistance, please contact the Customer Service Centre: Email: custserviec.ch Tel: +41 22 919 02 11 Fax: +41 22 919 03 00 TECHNICAL REPORT IEC TR 60825-8Second edition 2006-12Safety of laser pro
8、ducts Part 8: Guidelines for the safe use of laser beams on humans PRICE CODE IEC 2006 Copyright - all rights reserved No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing
9、from the publisher. International Electrotechnical Commission, 3, rue de Varemb, PO Box 131, CH-1211 Geneva 20, Switzerland Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmailiec.ch Web: www.iec.ch W For price, see current catalogue Commission Electrotechnique Internationale Interna
10、tional Electrotechnical Commission 2 TR 60825-8 IEC:2006(E) CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope and object6 2 Normative references6 3 Terms and definitions .6 4 Hazards, goals and control measures9 4.1 Risks to eyes.9 4.2 Risks to skin10 4.3 Fire and burn hazards11 4.4 Fumes, plumes and vapou
11、rs 12 4.5 Collateral hazards13 5 Administrative procedures.13 5.1 LASER SAFETY OFFICER (LSO) .13 5.2 Medical supervision (ophthalmic surveillance)15 5.3 INCIDENT and ACCIDENT reporting15 5.4 Maintenance and inspection.16 6 Training recommendations16 7 Laser environment 17 7.1 The LASER CONTROLLED AR
12、EA17 7.2 Windows .18 7.3 Walls.18 7.4 Fire protection .18 Annex A (informative) Biological effects, hazards, laser equipment technology19 Annex B (informative) Window shielding.26 Annex C (informative) Checklist for laser installation 27 Annex D (informative) Laser safety training 30 Annex E (inform
13、ative) Inspection schedule .31 Annex F (informative) Safety issues in laser applications36 Bibliography40 Table A.1 Summary of pathological effects associated with excessive exposure to light 20 Table E.1 Inspection schedule33 TR 60825-8 IEC:2006(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ SAFE
14、TY OF LASER PRODUCTS Part 8: Guidelines for the safe use of laser beams on humans FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to pro
15、mote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides
16、 (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC al
17、so participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as poss
18、ible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. Wh
19、ile all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake
20、 to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to ind
21、icate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents includin
22、g individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance
23、 upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the eleme
24、nts of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical
25、 report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC 60825-8, which is a technical report, has been prepared by IEC technical committee 76: Optical radiation safety and laser equipment. This sec
26、ond edition cancels and replaces the first edition published in 1999. It constitutes a technical revision. This second edition, which is the result of continued maintenance work on the previous edition, reflects more thorough consideration of the hazards involved. It also takes into account newer la
27、ser technology and laser radiation supply instrumentation, and addresses refined application procedures. Additionally, this second edition implements more recent information available from other standards relevant to safety procedures, which have been revised in recent years. Further technical devel
28、opments in this area will be reflected on an ongoing basis in future amendments or editions of this technical report. 4 TR 60825-8 IEC:2006(E) The text of this technical report is based on the following documents: Enquiry draft Report on voting 76/316/DTR 76/329/RVC Full information on the voting fo
29、r the approval of this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. Terms indicated in small capitals are defined in Clause 3. A list of all parts of the IEC 60825-8 series, pu
30、blished under the general title Safety of laser products, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the sp
31、ecific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. A bilingual version of this technical report may be issued at a later date. TR 60825-8 IEC:2006(E) 5 INTRODUCTION Lasers emit visible and/or invisible optical radiation. In so
32、me cases, this radiation is a parallel beam with almost no divergence. This means that the inherently high IRRADIANCE of the laser may be maintained over considerable distances. Because of this, the beam may be focused to a very small area, which may be hazardous to the eye or skin. Annex A includes
33、 descriptions of laser systems and some medical applications. Lasers may present hazards to anyone present during the operation of the laser. Serious risks of injury, in particular to the eye, and/or undesired effects can result from lack of protective measures, the use of faulty laser equipment, mi
34、sdirected beams or inappropriate laser control settings. This guide is intended to give direction as to how aspects of laser safety may be incorporated into medical laser practice. Its publication as a technical report indicates that it is not intended to take precedence over existing or proposed na
35、tional guidance. However, where none exists, this guide should prove helpful. Although the LASER OPERATOR has direct responsibility for safety during laser use, the employer bears the responsibility for the setting up of a framework for the safe use of the system. This guide strongly advocates the a
36、ppointment of a LASER SAFETY OFFICER to provide expert advice to the employer and all personnel concerned with the laser operation. This guide emphasizes the need for appropriate laser safety training for all staff involved in providing practical guidance on installation, operation, maintenance and
37、servicing. 6 TR 60825-8 IEC:2006(E) SAFETY OF LASER PRODUCTS Part 8: Guidelines for the safe use of laser beams on humans 1 Scope and object This part of IEC 60825 serves as a guide to the employer, the RESPONSIBLE ORGANISATION, the LASER SAFETY OFFICER, the LASER OPERATOR and other persons involved
38、, on the safe use of lasers and laser equipment classified as class 3B or class 4. It covers all applications of laser beams on humans in, but not limited to, health-care facilities, cosmetic and hair removal centres and dental practices, including applications in vehicles and domestic premises. NOT
39、E Although the scope excludes laser classes lower than class 3B and 4, it is appropriate to state, that particular care should be taken when levels of laser energy are used below the Class 3B and 4 limits when the individuals normal AVERSION RESPONSES are compromised or absent. This technical report
40、 explains the control measures recommended for the safety of patients, staff, maintenance personnel and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection. The subject
41、areas covered in this guide include BEAM DELIVERY SYSTEMS; biological effects of laser radiation; reporting of ACCIDENTS and dangerous situations; checklists. The object of this report is to enhance the protection of persons from laser radiation and other associated hazards by providing guidance on
42、how to establish safety procedures, precautions and user control measures. 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 referen
43、ced document (including any amendments) applies. None. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. NOTE Reference is also made, as indicated, to individual terms and definitions in IEC 60825-1 and IEC 60601-2-22. 3.1 accident unforeseen situa
44、tion which results in an injury to the patient and/or other personnel TR 60825-8 IEC:2006(E) 7 3.2 aversion response movement of the eyelid or the head to avoid an exposure to a noxious stimulant or bright light NOTE For visible lasers the AVERSION RESPONSE is assumed to occur within 0,25 s. 3.3 bea
45、m delivery system optical system which delivers the laser beam to the target area, focuses or shapes the laser beam and makes it manoeuvrable NOTE 1 Examples of a beam delivery system include fibre optic, handpiece, micromanipulator or scanning device. NOTE 2 See also 2.1.106 of IEC 60601-2-22. 3.4
46、incident potentially dangerous situation which could result in an injury to the patient and/or other personnel 3.5 irradiance RADIANT POWER divided by the irradiated area NOTE See also 3.39 of IEC 60825-1. IRRADIANCE is expressed in Wm -2 . 3.6 laser controlled area area where laser safety controls
47、apply NOTE See also 3.41 of IEC 60825-1. 3.7 laser operator person who handles the laser equipment and in general controls the application of the laser radiation at the working area NOTE The LASER OPERATOR may appoint other person(s), who assist with the selection and/or setting of the parameters. 3
48、.8 laser safety officer LSO one who is knowledgeable in the evaluation and control of laser hazards and has responsibility for oversight of the control of laser hazards IEC 60825-1, definition 3.47 3.9 maximum permissible exposure MPE that level of radiation to which, in normal circumstances, the sk
49、in or eye may be exposed without suffering adverse effects NOTE See also 3.55 and A.2 of IEC 60825-1. 3.10 nominal ocular hazard area NOHA area within which the IRRADIANCE or RADIANT EXPOSURE can exceed the MPE NOTE See also 3.59 of IEC 60825-1. 8 TR 60825-8 IEC:2006(E) 3.11 nominal ocular hazard distance NOHD distance from the laser aperture within which the IRRADIANCE or RADIANT EXPOSURE can exceed the MPE NOTE See also 3.60 of IEC 60825-1. 3
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