国内外生物安全实验室标准体系检测要求对比

作者:曹冠朋 曹国庆 张彦国 陈紫光 高鹏 刘波波 李洪庆
单位:中国建筑科学研究院有限公司 建科环能科技有限公司 中国科学院武汉病毒研究所 内蒙古必威安泰生物科技有限公司
摘要:系统梳理了包括WHO手册、美国手册BMBL-6、加拿大标准CBS-2、澳/新标准AS/NZS 2243.3及我国标准GB 50346、GB 19489在内的国内外生物安全实验室领域重要的标准或指南。重点介绍了标准或指南中关于实验室全面性能检测、认证方面的要求或规定,并对各标准中关于检测、认证方面的具体参数、指标要求和检测方法进行了对比分析。
关键词:生物安全实验室标准体系检测要求检测方法认证
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Comparison of test requirements of biosafety laboratory standard systems at home and abroad
Cao Guanpeng Cao Guoqing Zhang Yanguo Chen Ziguang Gao Peng Liu Bobo Li Hongqing
(China Academy of Building Research Co., Ltd. Building Environment and Energy,Jianke EET Co., Ltd. Wuhan Institute of Virology, CAS Inner Mongolia Bigvet Biotech Co., Ltd.)
Abstract: This paper systematically reviews the important standards or guidelines in the field of biosafety laboratory at home and abroad, including the WHO manual, the American manual BMBL-6, the Canadian standard CBS-2, the Australian/New Zealand standard AS/NZS 2243.3, and the Chinese standards GB 50346 and GB 19489. The requirements or provisions of the standards or guidelines on the comprehensive performance testing and certification of biosafety laboratories are highlighted, and the specific parameters, index requirements and test methods in various standards on testing and certification are compared and analysed.
Keywords: biosafety laboratory; standard system; test requirement; test method; certification;
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