IEC TR 61258-2008 Guidelines for the development and use of medical electrical equipment educational materials《医疗电气设备教材的开发和使用指南》.pdf

1、 IEC/TR 61258 Edition 2.0 2008-08 TECHNICAL REPORT Guidelines for the development and use of medical electrical equipment educational materials IEC/TR 61258:2008(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no par

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8、serv If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC/TR 61258 Edition 2.0 2008-08 TECHNICAL REPORT Guidelines for the development and use

9、 of medical electrical equipment educational materials INTERNATIONAL ELECTROTECHNICAL COMMISSION P ICS 11.040 PRICE CODE ISBN 2-8318-9974-5 Registered trademark of the International Electrotechnical Commission 2 TR 61258 IEC:2008(E) CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope.6 2 Terms and definition

10、s .6 3 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 development9 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

11、10 4.2.5 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 MATERIALs12 4.4 Selection of media and formats .12 4.5 Development and presentation of messages and materials13

12、 4.6 Validation 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 Bibliogr

13、aphy16 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 Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all nation

14、al 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 this end and in addition to other activities, IEC publishes International Standards, Technical

15、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. Int

16、ernational, governmental and non- governmental organizations liaising with the IEC also 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

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23、 of this publication. 9) Attention is drawn to the possibility that some of the elements 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

24、 Standards. However, a technical committee may propose the publication of a technical 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/TR 61258, which is a technical report, has been prepared

25、 by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 1994. This edition constitutes a technical revision. This edition ha

26、s been aligned with IEC 60601-1:2005 to include medical electrical systems within its scope. USABILITY ENGINEERING concepts from IEC 62366:2007 have also been added to this edition. 4 TR 61258 IEC:2008(E) The text of this technical report is based on the following documents: Enquiry draft Report on

27、voting 62A/615/DTR 62A/625/RVC Full information on the voting for 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. The committee has decided that the contents

28、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 specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingua

29、l version of this publication may be issued at a later date. TR 61258 IEC:2008(E) 5 INTRODUCTION The prevention and alleviation of public health problems arising from the use of medical electrical equipment and medical electrical systems are major concerns for many regulatory agencies, standards org

30、anizations, professional associations of health care personnel, and manufacturers. Incorrect use of medical electrical equipment or medical electrical systems can result in death or injury to patients, to health care personnel operating medical electrical equipment or medical electrical systems, or

31、consumers using such equipment. Government agencies often rely on regulatory approaches to solve problems related to the way the equipment is manufactured, marked, and described in the ACCOMPANYING DOCUMENTS, but many problems arise from erroneous use of medical electrical equipment or a medical ele

32、ctrical system. Errors in using equipment are made for a variety of reasons, including lack of knowledge about its proper use, impediments or lack of incentives for appropriate use. For these user problems, non-regulatory strategies might be necessary. These require an analysis of the problems and t

33、he development of EDUCATIONAL MATERIALS and programs to address misunderstandings and bad habits that can cause the problems. The development and use of materials and programs are an essential part of the health care facilities “quality system“. For information on quality systems, see ISO 9001, ISO

34、9004 and ISO 13485. 6 TR 61258 IEC:2008(E) GUIDELINES FOR THE DEVELOPMENT AND USE OF MEDICAL ELECTRICAL EQUIPMENT EDUCATIONAL MATERIALS 1 Scope IEC/TR 61258, which is a technical report, outlines a generic process for developing materials for education and training of OPERATORS of medical electrical

35、 equipment or a medical electrical system, hereafter referred to collectively as equipment. It can be used by standards organizations, manufacturers, health care facility managers, clinical engineers, physician and nurse educators, and others involved directly or indirectly in education and training

36、 of OPERATORS. In particular, manufacturers might find this process useful in preparing the necessary markings, ACCOMPANYING DOCUMENTS and other EDUCATIONAL MATERIALS which will provide necessary information to OPERATORS of the equipment and encourage them to employ safe and effective practices. Thi

37、s technical report is not intended to be used for regulatory purposes. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 ACCOMPANYING DOCUMENTS documents accompanying medical electrical equipment, a medical electrical system, other equipment or

38、 an accessory and containing information for the responsible organization or OPERATOR, particularly regarding basic safety and essential performance IEC 60601-1:2005, definition 3.4, modified 2.2 EDUCATIONAL MATERIALS means used to disseminate information for the purpose of training, instruction, an

39、d education of OPERATORS of equipment 2.3 INTENDED USE INTENDED PURPOSE use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer ISO 14971:2007, definition 2.5, modified 2.4 OPERATOR person handling equipment IEC 60601-1:20

40、05, definition 3.73 TR 61258 IEC:2008(E) 7 2.5 QUALITY ASSURANCE part of quality management focused on providing confidence that quality requirements will be fulfilled ISO 9000:2005, definition 3.2.11 NOTE 1 Unless given requirements fully reflect the needs of the responsible organization, QUALITY A

41、SSURANCE will not be complete. NOTE 2 For effectiveness, QUALITY ASSURANCE requires a continuing evaluation of factors that affect the adequacy of the design or specification for intended applications as well as verifications and audits of production, installation and inspection operations. Providin

42、g confidence can involve producing evidence. NOTE 3 Within an organization, QUALITY ASSURANCE also serves to provide confidence in the supplier. 2.6 USABILITY ENGINEERING application of knowledge about human behaviour, abilities, limitations, and other characteristics related to the design of tools,

43、 devices, systems, tasks, jobs, and environments to achieve adequate usability IEC 62366:2007, definition 3.18 3 General aspects Assuring the safety and performance of equipment not only requires attention to the design, testing, review and manufacture of the equipment itself, but it also requires O

44、PERATORS with the know-how to use the equipment safely for its INTENDED PURPOSE and the motivation to apply that knowledge. There are a number of ways in which OPERATORS might gain information about the appropriate use of equipment. These sources include theory, training and over-the-shoulder learni

45、ng gained from experienced personnel, and from the information supplied by marking and in the ACCOMPANYING DOCUMENTS. Some equipment can be incorrectly used due to inadequate marking and instructions for use. Because this information is important to the OPERATOR, it should be written in the appropri

46、ate language and reading level. Knowledge of equipment or ability that is not typical for the lay person is not to be presumed. Inadequate marking and ACCOMPANYING DOCUMENTS are not the only cause of erroneous use by the OPERATOR. Other reasons, such as lack of motivation, inadequate experience or t

47、raining, and environment variables such as an overcrowded work situation, can cause OPERATORS to use the equipment in a manner contrary to the instructions for use. For example, the use of anaesthesia equipment without performing a complete pre-use check-out procedure illustrates the point that adeq

48、uate information itself does not guarantee a particular OPERATOR behaviour. This can happen despite the fact that the marking and instructions for use of most anaesthesia systems include such pre-use procedures Because problems with equipment can be due to several contributing factors, some of which

49、 might not be obvious or easy to discover, a comprehensive analysis of a problem related either to the equipment itself or to its use, is a prerequisite for the implementation of effective measures to resolve it. Limiting the analysis can cause lengthy delays in resolving the problem. Likewise, limiting the analysis can result in selecting solution strategies that are unnecessarily costly. Therefore, before developing an educational strategy to address an equipment problem area, the following two logical s