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Medical electrical equipment - Medical light ion beam equipment - Performance characteristics 医疗电气设备 医用轻离子束设备 性能特点
发布日期: 2017-08-23
IEC 62667:2017适用于在人类医疗实践中用于治疗目的的轻离子束ME设备。 本文件适用于轻离子束ME设备,该设备提供每个核子能量在10 MeV/n至500 MeV/n范围内的轻离子束。 本文件描述了轻离子束ME设备制造商应执行的测量和测试程序,但未指定验收测试。 本文件规定了确定和披露性能特征的测试程序,这些知识对于正确选择、应用和使用轻离子束ME设备是必要的,这些知识将在随附文件中声明,以及在正常使用的特定条件下预期的最大偏差或变化。性能值的列报格式见附件A。
IEC 62667:2017 applies to light ion beam ME equipment when used, for therapy purposes, in human medical practice.
This document applies to light ion beam ME equipment which delivers light ion beams with an energy per nucleon in the range 10 MeV/n to 500 MeV/n.
This document describes measurements and test procedures to be performed by the manufacturer of light ion beam ME equipment but does not specify acceptance tests.
This document specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is necessary for proper selection, application, and use of light ion beam ME equipment and which are to be declared in the accompanying documentation together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of performance values is given in Annex A.

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归口单位: TC 62/SC 62C
相似标准/计划/法规
现行
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2019-11-25
现行
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2018-04-24
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DIN EN IEC 62667
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2005-01-01
现行
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DIN EN 60601-2-64
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