高级别生物安全实验室建设关键问题及应对措施  

Key issues and countermeasures for constructing high-level biosafety laboratories

作　　者：薛森仁 郑小奇 张贤宇 李小波 石凤霞 林静雯 韩建保 XUE Senren;ZHENG Xiaoqi;ZHANG Xianyu;LI Xiaobo;SHI Fengxia;LIN Jingwen;HAN Jianbao(Biosafety Laboratory,West China Hospital of Sichuan University,Chengdu 610041,China)

机构地区：[1]四川大学华西医院生物安全实验室,四川成都610041

出　　处：《实验技术与管理》2024年第5期226-231,共6页Experimental Technology and Management

摘　　要：为提升高级别生物安全实验室建设管理体系能力,国家编制和发布了一系列法律法规、标准、制度与规划。文章基于实验室建设、使用与运行管理的多重角度,从实验室围护结构建设、设施设备调研与入场、机电安装与调试、科研仪器调研与采购、人员组织架构搭建等方面总结了高级别生物安全实验室建设过程中需要关注的关键问题,并依据工作经验提出可行的应对措施。文章还探讨了实验室从立项到认证流程,以及备案筹备阶段面临的关键问题,以期为高级别生物安全实验室建设管理提供借鉴、参考和思路。[Significance]There are protective measures to be considered by laboratories handling biological agents,and laboratory biosafety protection is divided into four levels.In China,biosafety awareness and extensive cognition have been improved with the large-scale construction of biosafety level 2 laboratories in various places;however,high-level biosafety laboratories(biosafety laboratories with biosafety protection levels 3 and 4)started late,and system construction still needs to be improved.[Progress]In the 1950s and 1960s,the earliest biosafety laboratories were constructed in the United States.In the 1980s,China cooperated with Europe,the United States,Japan,and other countries to build their first batch of high-level biosafety laboratories,and in the 1990s,China began to design and build high-level biosafety laboratories on their own.Currently,many new and renovated projects are still available across the country,and the common problems highlighted in the construction process are worth exploring.[Conclusions and Prospects]To improve and accelerate the construction of high-level biosafety laboratories and the capacity of the national management system,our country has compiled and issued a series of laws,regulations,standards,systems,and plans.From the multiple perspectives of laboratory construction,use,and operation management,this paper summarizes the key problems existing in the construction of high-level biosafety laboratories from the aspects of laboratory envelope construction,facilities and equipment research and admission,mechanical and electrical installation and commissioning,scientific research instruments and procurement,personnel organization,structure construction,and puts forward feasible countermeasures based on work experience.In addition,this paper summarizes,analyzes,and discusses the key issues faced by laboratories in the process from project initiation to certification and the preparation stage for filing to provide references and ideas for other high-level biosafety laboratories.According

关 键 词：高级别生物安全实验室 实验室建设 生物安全 应对措施 

分 类 号：R187[医药卫生—流行病学]