
Medical electrical equipment –Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
出版:International Electrotechnical Committee

专家解读视频
Replace, in the first paragraph, the first existing sentence by the following new sentence: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. Replace the second existing paragraph by the following new paragraph: ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography, dental or radiotherapy applications are excluded from the scope of this International Standard.
I.S. EN 60601-2-54:2009&A1:2015&A2:2019 - Identical