放射性药品检验实验室辐射安全管理探析  

Exploration of Radiation Safety Management in Radioactive Drug Testing Laboratories

作　　者：裴云飞 张文在 王全柱 张伟[1] 倪训松[1] 郭亚新[1] Pei Yunfei;Zhang Wenzai;Wang Quanzhu;Zhang Wei;Ni Xunsong;Guo Yaxin(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2024年第12期1379-1386,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:为药品检验机构放射性药品检验实验室辐射安全管理提供建设性意见。方法:对放射性药品市场需求和检验实验室发展现状进行分析,概述辐射安全管理的相关概念、分类及法规,归纳放射性实验室建设、许可、退役及日常辐射安全管理的有关要求,统计分析近年发生的辐射事故的共性原因,探讨放射性药品检验实验室辐射安全管理存在的风险,提出有针对性的解决措施。结果与结论:放射性药品检验实验室要瞄准国际建设前沿,严格执行辐射项目建设“三同时”,持续完善辐射安全管理制度,坚持严格的教育培训考核,配备高标准的设施设备,不断夯实辐射安全管理基础,促进放射性药品检验新质安全生产力快速发展。Objective:To provide constructive suggestions for the radiation safety management of radioactive drug testing laboratories in drug inspection institutions.Methods:A brief analysis was conducted on the demand for radioactive drugs in the market and the current development status of inspection laboratories.The relevant concepts,classifications,and regulations of radiation safety management were outlined,and the requirements for the construction,licensing,retirement,and daily radiation safety management of radioactive laboratories were summarized.The common causes of radiation accidents in recent years were statistically analyzed,and the risks of radiation safety management in radioactive drug inspection laboratories were discussed.Targeted solutions were proposed.Results and Conclusion:The radioactive drug testing laboratory should aim at the forefront of international construction,strictly implement the"three simultaneities"of radiation project construction,continuously improve the radiation safety management system,adhere to strict education,training and assessment,equip with high standard facilities and equipment,continuously consolidate the foundation of radiation safety management,and promote the rapid development of new quality and safety productivity in radioactive drug inspection.

关 键 词：放射源 射线装置 监督管理 放射性药品 实验室 辐射安全 

分 类 号：R95[医药卫生—药学]