医疗电气设备教材的开发和使用指南

[中文适用范围]： IEC/TR 61258 是一份技术报告，概述了开发用于医疗电气设备或医疗电气系统（以下统称为设备）操作员教育和培训材料的通用流程。它可供标准组织、制造商、医疗保健机构管理者、临床工程师、医生和护士教育者以及其他直接或间接参与操作者教育和培训的人员使用。特别是，制造商可能会发现此过程对于准备必要的标记、随附文件和其他教育材料很有用，这些材料将为设备操作员提供必要的信息并鼓励他们采用安全有效的做法。本技术报告无意用于监管目的。 [外文原描述]： 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.