国内外生物安全实验室标准体系检测要求发展
摘要:本文系统梳理了包括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GB 50346、GB 19489在内的国内外生物安全实验室领域的重要标准或指南。重点介绍了国内外标准体系在检测、认证要求方面的发展,以及各标准重点修订内容。
关键词:生物安全实验室标准体系检测认证修订
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参考文献[1] 世界卫生组织.实验室生物安全手册[M].3版.北京:人民卫生出版社,2004:29-38.
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[4] Public Health Agency of Canada.Canadian biosafety handbook (CBH)[M/OL].2nd ed.[2020-12-13].https://www.canada.ca/content/dam/phac-aspc/migration/ cbsg-nldcb/ cbh-gcb/ assets/pdf/cbh-gcb-eng.pdf.
[5] Joint Technical Committee CH-026.Safety in laboratories:part 3:microbiological safety and containment:AS/NZS 2243.3:2010[S].Australian/New Zealand:SAI Global Limited,2010:38-74.
[6] 中国合格评定国家认可中心.实验室生物安全通用要求:GB 19489—2008[S].北京:中国标准出版社,2008:4-15.
[7] 中国建筑科学研究院.生物安全实验室建筑技术规范:GB 50346—2011[S].北京:中国建筑工业出版社,2012:13-18,31-79.
[8] 中国合格评定国家认可中心.实验室设备生物安全性能评价技术规范:RB/T 199—2015[S].北京:中国标准出版社,2016:2-12.
[9] 中国建筑科学研究院.洁净室施工及验收规范:GB 50591—2010[S].北京:中国建筑工业出版社,2011:105-110.
[10] 北京市医疗器械检验所.Ⅱ级生物安全柜:YY 0569—2011[S].北京:中国标准出版社,2011:3-8.
[11] 中国建筑科学研究院.排风高效过滤装置:JG/T 497—2016[S].北京:中国标准出版社,2016:2-7.
Test requirement development of biosafety laboratory standard system at home and abroad
Abstract: This paper systematically combs the important standards or guidelines in the field of biosafety laboratories at home and abroad, including the WHO handbook, American handbook BMBL-6, Canadian standard CBS-2, Australian/New Zealand standard AS/NZS 2243.3 and Chinese GB 50346 and GB 19489, and mainly presents the development of testing and certification requirements of the standards system at home and abroad, as well as the key revision of each standard.
Keywords: biosafety laboratory; standard system; test; certification; revision;
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