标准摘要
[中文适用范围]: 本国际标准适用于 X 射线管组件及其组件的基本安全和基本性能: – 以下简称 ME 设备; – 用于医学诊断和成像。如果某条款或子条款专门旨在仅适用于 ME 设备或仅适用于 ME 系统,则该条款或子条款的标题和内容将如此说明。如果情况并非如此,则该条款或子条款适用于相关的 ME 设备和 ME 系统。 [外文原描述]: IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.
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