IEC TR 61258:2008 

Guidelines for the development and use of medical electrical equipment educational materials

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Abstract

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.

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Additional information

Publication typeTechnical Report
Publication date2008-08-28
Edition2.0
Available language(s)English
TC/SCTC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss
ICS11.040.01 - Medical equipment in general
Stability date  2026
Pages16
File size874 KB

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