IEC TR 61258:2008
(Main)Guidelines for the development and use of medical electrical equipment educational materials
Guidelines for the development and use of medical electrical equipment educational materials
IEC/TR 61258:2008(E), which is a technical report, outlines a generic process for developing materials for education and training of operators of medical electrical 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 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. This technical report is not intended to be used for regulatory purposes. This second edition cancels and replaces the first edition published in 1994. This edition constitutes a technical revision. This edition has 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.
General Information
Standards Content (Sample)
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)
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IEC/TR 61258
Edition 2.0 2008-08
TECHNICAL
REPORT
Guidelines for the development and use of medical electrical equipment
educational materials
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
P
ICS 11.040 ISBN 2-8318-9974-5
– 2 – TR 61258 © IEC:2008(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5
1 Scope.6
2 Terms and definitions .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 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 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 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
Bibliography.16
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 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
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
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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 formal decisions or agreements of IEC on technical matters express, as nearly as possible, 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
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC provides no marking procedure to indicate 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 including individual experts and
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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 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 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 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 has 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 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 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 bilingual 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 organizations, 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 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
electrical 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 the 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 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 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 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.
This 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 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, and 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 60601-1:2005, 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 ASSURANCE 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 a
...
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