医疗电气设备. 第2-64部分: 轻离子束医用电气设备基本安全和基本性能的特殊要求

[中文适用范围]： 本标准适用于用于患者治疗的光离子束医疗电气设备（ME 设备）的基本安全和基本性能。如果在条款或子条款中 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. 本特定标准，包括型式试验和现场试验，分别适用于用于人类医学实践放射治疗的轻离子束 ME 设备的设计制造和部分安装方面：a) 其中运行参数的选择和显示可以由可编程电子子系统 (PESS) 自动控制；b) 在正常使用下，提供能量每核子在 10 MeV/n 到 500 MeV/n 范围内的轻离子束；c) intended to be operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the INSTRUCTIONS FOR USE, and subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON。 [外文原描述]： IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of ME equipment intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems, that, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n. Key words: nuclear medicine, radiation dosimetry.