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现行 IEC TR 60930:2008
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Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems 与医疗电气设备和医疗电气系统的安全使用有关的行政、医疗和护理人员指南
发布日期: 2008-09-19
IEC/TR 60930:2008(E)旨在通过提供安全应用规范,降低对患者、操作员及其周围环境的风险。除此之外,医疗电气设备、医疗电气系统和医疗场所电气装置(以下分别称为医用电气设备、医用电气系统和装置)中的风险控制措施也带来了风险降低。 并非所有现有医用电气设备、医用电气系统或装置都符合相关IEC标准的要求。操作员和责任机构不时会遇到符合旧安全标准的医用电气设备和医用电气系统。 然而,应尽可能遵守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用于家用医疗环境中的医用电气设备或医用电气系统,前提是制造商已将家用纳入预期用途,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。 如果医用电气设备、医用电气系统或装置不符合相关IEC标准,责任机构应咨询临床工程部门或制造商,以获取如何达到适当安全水平的说明。 第二版取消并取代1988年出版的第一版。本版为技术修订版。本版本符合IEC 60601-1:2005、IEC 60601-1-2:2007、IEC 60601-1-8:2006和IEC 62353:2007。本版本包括其范围内的医疗电气系统。
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.
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归口单位: TC 62/SC 62A
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