碳离子治疗系统放射性能现场测试评价研究  

Evaluation of Radiation Therapy Performance of Carbon Ion Therapy Therapy System

作　　者：郭虎 申彦峰 杨成乐 梁成鑫 GUO Hu;SHEN Yan-feng;YANG Cheng-le;LIANG Cheng-xin(Gansu Provincial Institute of Equipment Inspection and Testing,Gansu Lanzhou 730000;Lanzhou Kejin Taiji New Technology Co.,Ltd.,Gansu Lanzhou 730000)

机构地区：[1]甘肃省器械检验检测所,甘肃兰州730000 [2]兰州科近泰基新技术有限公司,甘肃兰州730000

出　　处：《中国医疗器械信息》2024年第23期12-15,共4页China Medical Device Information

摘　　要：重离子设备作为近年来发展迅速的一种医疗设备,运用同步回旋加速器将重离子加速至高能量,利用先进的激光定位系统和图像引导系统,精准聚焦患者的肿瘤靶向组织,以确保放疗效果的安全有效,保障患者的生命健康安全。因此,在对患者进行诊疗之前,对放射粒子束流的控制和性能监测极其重要。我国碳离子治疗系统第一台在上市注册检验过程中,其治疗子系统中的性能项目项目主要依据引用IEC 60601-2-64:2014《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》和IEC 62667:2017《轻离子束治疗系统性能指标要求》进行验证检验和结果评判国内标准YY/T1763-2021《医疗电气设备医用轻离子束设备性能特性》由全国医用电器标准化技术委员会放射治疗核医学和放射剂量学设备分技术委员会于2021年03月09日发布,2022年10月01日正式实施,作为从大科学装置转化为大型高端医疗设备的跨越性产品,在临床运行过程中风险较高,需按照相应的产品标准制定现场检验方案势在必行,进行风险防控,为持续提高碳离子治疗系统产品性能进行技术参考。Heavy ion equipment as a rapidly developing medical equipment in recent years,the use of synchrocyclotron to accelerate heavy ions to high energy,the use of advanced laser positioning system and image guidance system,accurate focus on the patient’s tumor targeting tissue,to ensure the safety and effectiveness of radiotherapy,to protect the life and health safety of patients,therefore,before the diagnosis and treatment of patients,The control and performance monitoring of radioactive particle beam is extremely important.During the listing registration and inspection process of the first carbon ion therapy system,the performance items in its treatment subsystem are mainly based on IEC 60601-2-64:2014“Medical Electrical Equipment Part 2-64:Special requirements for Basic Safety and Basic Performance of Light ion Beam Medical Electrical Equipment”and IEC 62667:2017“Requirements for Performance Indicators of Light ion Beam Treatment Systems”for verification and evaluation of results.Domestic standard YY/T1763-2021“Performance Characteristics of Medical Electrical Equipment Medical Light ion Beam Equipment”by the National Technical Committee for Standardization of Medical Electrical Equipment Radiation Therapy Nuclear Medicine and radiation dosimetry equipment Technical Committee issued on March 09,2021,officially implemented on October 01,2022.As a leapfrog product transforming from a large scientific device to a large high-end medical device,the risk is high in the clinical operation process,it is imperative to formulate an on-site inspection program in accordance with the corresponding product standards,carry out risk prevention and control,and provide technical reference for continuously improving the performance of carbon ion therapy system products.

关 键 词：碳离子治疗系统 Bragg峰 轻离子束射野 现场测试 

分 类 号：TH774[机械工程—仪器科学与技术]