EN 60601-2-54:2009
医用电气设备 第 2-54 部分：X 射线照相和透视用 X 射线设备的基本安全和基本性能的特殊要求（包含修正案 A1：2015）

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Incorporates Amendment A1: 2015)

EN 60601-2-54:2009 发布历史

EN 60601-2-54:2009由CENELEC - European Committee for Electrotechnical Standardization 发布于 2009-09-01，并于 2018-07-26 实施。

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EN 60601-2-54:2009的历代版本如下：

• 2009年 EN 60601-2-54:2009 医用电气设备 第 2-54 部分：X 射线照相和透视用 X 射线设备的基本安全和基本性能的特殊要求（包含修正案 A1：2015）

Replacement: 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 RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry@ computed tomography@ mammography or dental applications are excluded from the scope of this International Standard. The scope of this International Standard also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and content of that clause or subclause will say so. If that is not the case@ the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS@ as relevant. NOTE Taking into account economic and social factors@ the scope of this particular standard includes ME EQUIPMENT intended to be used for DIRECT RADIOSCOPY. In some countries examinations performed with DIRECT RADIOSCOPY are prohibited.

标准号

EN 60601-2-54:2009

发布

2009年

发布单位

CENELEC - European Committee for Electrotechnical Standardization

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