医用电气设备第2-28部分:医疗诊断用X射线管组件基本安全和基本性能的特殊要求

[中文适用范围]： 本部分IEC 60601适用于X射线管组件及其部件的BASIC SAFETY和ESSENTIAL PERFORMANCE，用于医疗诊断和成像。当通用标准IEC 60601-1和附属标准IEC 60601-1-3提到ME EQUIPMENT时，在本特定标准中解释为X射线管组件。如果某条款或子条款专门适用于ME EQUIPMENT或ME SYSTEMS，该条款或子条款的标题和内容会明确说明。如果没有说明，则该条款或子条款适用于ME EQUIPMENT和ME SYSTEMS。 [外文原描述]： IEC 60601-2-28:2017 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its 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.