1、 IEC/TR 61258Edition 2.0 2008-08TECHNICAL REPORT Guidelines for the development and use of medical electrical equipment educational materials IEC/TR 61258:2008(E)LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.THIS PUBLICATION IS COPYR
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7、.Available on-line and also by email.?Electropedia:www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French,with equivalent terms in additional languages.Also known as the International Electr
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9、ON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.IEC/TR 61258Edition 2.0 2008-08TECHNICAL REPORT Guidelines for the development and use of medical electrical equipment educational materials INTERNATIONAL ELECTROTECHNICAL COMMISSION PICS 11.040 PRICE C
10、ODEISBN 2-8318-9974-5 Registered trademark of the International Electrotechnical Commission LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.2 TR 61258 IEC:2008(E)CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope.6 2 Terms and definitions.6 3
11、General aspects.7 4 Development and use of educational programs and materials.8 4.1 Program goals.8 4.2 Division of tasks for information development.9 4.2.1 Manufacturers.9 4.2.2 Health care facility managers.9 4.2.3 Medical,paramedical and clinical engineering personnel.10 4.2.4 Educators.10 4.2.5
12、 Standards-writing organizations.11 4.3 Data collection.11 4.3.1 Information to consider about equipment.11 4.3.2 Information to consider about the audience(s)for the EDUCATIONAL MATERIALs.12 4.4 Selection of media and formats.12 4.5 Development and presentation of messages and materials.13 4.6 Vali
13、dation of information content and presentation.13 4.6.1 Testing of EDUCATIONAL MATERIAL during product development.13 4.6.2 Testing of EDUCATIONAL MATERIAL during equipment use.14 4.7 Distribution and use.14 4.8 Follow-up of EDUCATIONAL MATERIAL.14 5 Patients and lay OPERATORS.14 Bibliography.16 LIC
14、ENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.TR 61258 IEC:2008(E)3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ GUIDELINES FOR THE DEVELOPMENT AND USE OF MEDICAL ELECTRICAL EQUIPMENT EDUCATIONAL MATERIALS FOREWORD 1)The International El
15、ectrotechnical Commission(IEC)is a worldwide organization for standardization comprising all national electrotechnical committees(IEC National Committees).The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields.To
16、 this end and in addition to other activities,IEC publishes International Standards,Technical Specifications,Technical Reports,Publicly Available Specifications(PAS)and Guides(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 also participate in this preparati