GB/T 19046-2013 in English

《GB/T 19046-2013医用电子加速器 验收试验和周期检验规程》由TC10（全国医用电器标准化技术委员会）归口，主管部门为国家药品监督管理局。
本标准规定了医用电子加速器验收试验和周期检验的性能要求、试验方法、试验条件和检验周期。
本标准适用于医用电子加速器初次安装后，制造方、使用方和第三方共同进行的验收试验,以及设备正常工作中,使用方进行的周期检验。
本标准适用于医疗事业中以放射治疗为目的、能产生X-辐射和电子辐射、标称能量为1 MeV～50 MeV的医用电子加速器。
本标准适用于配备有等中心机架的医用电子加速器,对非等中心设备的性能和试验方法亦可参照执行。

Scope

This standard specifies the performance requirements, test methods, test conditions and inspection cycles for acceptance tests and periodic inspections of medical electron accelerators. This standard applies to acceptance tests conducted jointly by the manufacturer, user and third party after the initial installation of the medical electron accelerator, as well as periodic inspections conducted by the user during normal operation of the equipment. This standard applies to medical electron accelerators used for radiotherapy in the medical industry that can generate X-radiation and electron radiation with a nominal energy of 1 MeV to 50 MeV. This standard applies to medical electron accelerators equipped with isocentric racks, and can also be used as a reference for the performance and test methods of non-isocentric equipment.