管理、医疗、护理人员安全使用医疗电气设备和医疗电气系统用指南

[中文适用范围]： 本技术报告旨在通过提供安全应用准则来降低患者、操作者及其周围环境的风险。除了医疗电气设备、医疗电气系统和医疗场所电气装置（以下分别称为 ME 设备、ME 系统和装置）中纳入的风险控制措施之外，还可以降低风险。并非所有现有 ME 设备、ME 系统或装置都满足相关 IEG 标准的要求。有时，运营商和责任组织会遇到符合旧安全标准的 ME 设备和 ME 系统。然而，在可能的情况下，仍应遵循本技术报告中给出的安全应用指南。本技术报告中的指南可与 ME 设备或 ME 系统一起用于家庭医疗保健环境，前提是制造商已将家庭使用纳入预期用途，或者临床工程部门已检查电气安装和物理环境不会导致任何不可接受的风险。这些指南也适用于用于补偿或减轻疾病、伤害或残疾的设备。如果 ME 设备、ME 系统或安装不符合相关 IEC 标准，责任组织应咨询临床工程部门或制造商，以获取有关如何达到足够安全水平的说明。 [外文原描述]： IEC/TR 60930:2008(E) is intended to lessen the risk to patients, operators, and their surroundings by providing a code of safe application. This reduction of risk is in addition to that brought about by the risk control measures incorporated in the medical electrical equipment, the medical electrical system, and the electrical installation in medical locations, hereafter referred to as me equipment, me system and installation respectively. Not all existing me equipment, me systems or installations meet the requirements of the relevant IEC standards. From time to time, operators and responsible organizations will encounter me equipment and me systems complying with older safety standards. However, the guidelines for safe application given in this technical report should nevertheless be followed in so far as this is possible. The guidelines in this technical report can be used with me equipment or me systems for the home healthcare environment provided the manufacturer has included home use in the intended use or the clinical engineering department has checked that the electrical installation and the physical environment will not result in any unacceptable risks. These guidelines can also be applied to equipment used for compensation or alleviation of disease, injury or disability. If the me equipment, an me system or the installation does not comply with the relevant IEC standards, the responsible organization should consult with the clinical engineering department or the manufacturer for instructions on how to achieve an adequate level of safety. This second edition cancels and replaces the first edition published in 1988. This edition constitutes a technical revision. This edition has been aligned with IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-8:2006 and IEC 62353:2007. This edition includes medical electrical systems within its scope.