IEC 60601-2-28:2017 医疗电气设备 - 第2-28部分:医疗诊断X射线管组件的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-28:2017

中文名称：医疗电气设备 - 第2-28部分:医疗诊断X射线管组件的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

发布日期：2017-06-16

标准范围

新的！IEC 60601-2-28:2017作为IEC 60601-2-28:2017 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 60601-2-28:2017适用于用于医疗诊断和成像的X射线管组件及其组件的基本安全性和基本性能。如果通用标准IEC 60601-1和附属标准IEC 60601-1-3提及me设备，则在该特定标准中，这被解释为X射线管组件。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。该特定标准的第三版已准备好适应IEC 60601-1:20 05和IEC 60601-1:20 05/AMD1:2012（IEC 60601-1的修订第三版），其被称为通用标准。除了与IEC 60601-1修订相关的变更外，还包括与技术改进相关的变更。

NEW!IEC 60601-2-28:2017 is available as IEC 60601-2-28:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.

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