標準號：BS EN 60601-2-54-2009
中文標準名稱：醫用電子設備.放射線照相術和放射線透視用X射線設備基本安全性和主要性能的詳細要求
英文標準名稱：Medical electrical equipment - Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
標準類型：C43
發布日期：2010/3/31 12:00:00
實施日期：2010/3/31 12:00:00
中國標準分類號：C43
國際標準分類號：11.040.50
適用范圍：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY andRADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be usedfor interventional applications and refers to applicable requirements in this particularstandard.ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorptiondensitometry, computed tomography, mammography or dental applications are excluded fromthe scope of this International Standard. The scope of this International Standard alsoexcludes radiotherapy simulators.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.