标准化管理是保证生物安全实验室安全运行的基础和前提。SARS爆发后,我国相继建成不同安全等级的生物安全实验室,生物实验室的专业化、标准化管理体系的构建和运作已经成为必然关注的核心问题。文章详细阐述了我国目前生物安全实验室运行管理标准的领域、分类与存在不足,通过对发达国家高等级生物安全实验室管理标准化体系的剖析,思考和构建我国生物安全实验室标准化管理体系的框架,并提出具体的实施建议,期望推动我国实验室生物安全管理的标准体系建设和保障生物安全实验室的有效运行。
Standardized management is one of the key prerequisites to guarantee the effective and safe functioning ofhigh-lev- el biosafety laboratories. After the outbreak of SARS, more and more biosafety laboratories of different levels have been estab- lished in China. Special and standardized management system for biosafety laboratories has become a necessity and core con- cern. This paper describes the current status of Chinese standards on biosafety management and analyzes its relativity with oth- er laboratory biosafety standard systems in developed countries. Based on these analyses, a biosafety laboratory standard sys- tem framework is developed, and the policy environment for building the system is suggested, aiming to promote the promul- gation of specific biosafety standards and to secure the effective functioning of high-level biosafety laboratories