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现行 IEC TR 61258:2008
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Guidelines for the development and use of medical electrical equipment educational materials 医用电气设备教材的开发和使用指南
发布日期: 2008-08-28
IEC/TR 61258:2008(E)是一份技术报告,概述了开发医用电气设备或医用电气系统(以下统称为设备)操作员教育和培训材料的一般过程。标准组织、制造商、医疗机构管理人员、临床工程师、医生和护士教育工作者,以及其他直接或间接参与操作员教育和培训的人员可以使用它。尤其是,制造商可能会发现这一过程有助于准备必要的标记、随附文件和其他教育材料,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。本技术报告不用于监管目的。第二版取消并取代1994年出版的第一版。 本版为技术修订版。本版本符合IEC 60601-1:2005,将医疗电气系统纳入其范围。IEC 62366:2007中的可用性工程概念也被添加到本版本中。
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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归口单位: TC 62/SC 62A
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