IEC TR 61258:2008

FOREWORD
INTRODUCTION
1 Scope
2 Terms and definitions
3 General aspects
4 Development and use of educational programs and
  materials
  4.1 Program goals
  4.2 Division of tasks for information development
      4.2.1 Manufacturers
      4.2.2 Health care facility managers
      4.2.3 Medical, paramedical and clinical engineering
            personnel
      4.2.4 Educators
      4.2.5 Standards-writing organizations
  4.3 Data collection
      4.3.1 Information to consider about equipment
      4.3.2 Information to consider about the audience(s) for
            the EDUCATIONAL MATERIALs
  4.4 Selection of media and formats
  4.5 Development and presentation of messages and
      materials
  4.6 Validation of information content and presentation
      4.6.1 Testing of EDUCATIONAL MATERIAL during product
            development
      4.6.2 Testing of EDUCATIONAL MATERIAL during equipment
            use
  4.7 Distribution and use
  4.8 Follow-up of EDUCATIONAL MATERIAL
5 Patients and lay OPERATORS
Bibliography

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.