碳离子治疗系统自检实验室质量管理体系建设探讨  

Discussion on the Construction of Quality Management System for Self Inspection Laboratory of Carbon Ion Therapy System

作　　者：李素娟 潘国华 辛美玉 厍永进 关玉凤 Li Sujuan;Pan Guohua;Xin Meiyu;She Yongjin;Guan Yufeng(Lanzhou Ion Therapy Co.,Ltd.,Lanzhou Gansu 730000,China)

机构地区：[1]兰州泰基离子技术有限公司,甘肃兰州730000

出　　处：《医疗装备》2025年第3期27-32,共6页Medical Equipment

基　　金：甘肃省药品科研项目(2023GSMPA056)。

摘　　要：依据《医疗器械注册自检管理规定》并结合中国合格评定国家认可委员会(CNAS)实验室认可要求,从人员、设备、方法、设施和环境条件、检测、质量控制等方面分析碳离子治疗系统自检实验室质量管理体系的建立和运行关键点,并提出质量管理体系持续改进和优化建议,旨在推动碳离子治疗系统产业高质量发展,为有自检需求的大型医用设备注册申请人提供参考。According to the"Regulations on Self Inspection Management of Medical Device Registration"and the laboratory accreditation requirements of the China National Accreditation Service for Conformity Assessment(CNAS),the key points of the establishment and operation of the quality management system of the self inspection laboratory of carbon ion therapy system were analyzed from the aspects of personnel,equipment,methods,facilities and environmental conditions,testing,quality control and so on.In addition,suggestions for continuous improvement and optimization of the quality management system were put forward to promote the high-quality development of the carbon ion therapy system industry,and to provide a reference for large medical equipment registration applicants with self inspection needs.

关 键 词：碳离子治疗系统 自检 实验室 质量管理体系 

分 类 号：R95[医药卫生—药学]