BS EN 60601-2-54-2009 医用电子设备.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详细要求

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标准号:BS EN 60601-2-54-2009
中文标准名称:医用电子设备.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详细要求
英文标准名称:Medical electrical equipment - Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
标准类型:C43
发布日期:2010/3/31 12:00:00
实施日期:2010/3/31 12:00:00
中国标准分类号:C43
国际标准分类号:11.040.50
适用范围: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.

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