,第1版:医用电子设备.第2-54部分：放射线照相术和放射线透视用X射线设备基本安全性和主要性能的特殊要求

[中文适用范围]： 本国际标准适用于用于投影放射摄影和放射透视的医用电气设备（ME 设备）和医用电气系统（ME 系统）的基本安全和主要性能。IEC 60601-2-43 适用于用于介入应用的 ME 设备和 ME 系统，并引用本特定标准中的适用要求。本国际标准的范围不包括用于骨或组织吸收密度测定、计算机断层扫描、乳腺摄影或牙科应用的 ME 设备和 ME 系统。本国际标准的范围也不包括放射治疗模拟机。 [外文原描述]： IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda of March 2010 and June 2011 have been included in this copy.