生物安全隔离笼具产品和标准概况及现场检测结果
摘要：针对高等级生物安全实验室中隔离笼具 (IVC) 现场验收的实际需求, 分析了现有的IVC现场检测方法和评价标准, 并介绍了IVC性能指标现场检测验收情况的调研结果。结果表明:实验室中较多应用国外IVC品牌产品, 但已出现了国产IVC产品;实测中, 不同IVC换气次数为20100h-1, 甚至更高, 未出现换气次数不足的情况;9%左右的IVC压差值达不到标准要求;所测笼盒中4%左右达不到标准RB/T 199-2015中的气密性要求;目前, IVC送排风高效过滤器在现场检漏时基本采用全效率法检漏, 光度计全效率检漏方法可避免下游风机产尘的影响, 具有较好的应用前景。
关键词：高等级生物安全实验室 独立通风笼具 (IVC) 检测 性能指标 换气次数 压差
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参考文献作者简介：曹冠朋, 男, 1989年1月生, 硕士, 工程师
作者简介：曹国庆 100013北京市北三环东路30号环能院 (010) 64693447E-mail:cgq2000@126.com
收稿日期：2017-08-04
基金： “十三五”国家重点研发计划“高等级病原微生物实验室生物安全防护技术与产品研究”课题“实验室生物安全设备的现状分析与发展战略研究” (编号:2016YFC1201405) ;
Product and standard overview of biosafety isolating equipment-IVC and field test results
Cao Guanpeng Cao Guoqing Chen Yong Wang Rong
China Academy of Building Research
Abstract：
According to the actual demand of IVC field test for high-level biosafety laboratory, analyses the existing IVC field test methods and evaluation standards, and presents the survey results of field test and check of IVC performance indices.The results show that the products of overseas brands are widely used in laboratory while some domestic brands involve in, the air change rates of different IVCs range from 20 to 100 times per hour or even more, without insufficient air change rate, about nine percent of IVCs fail to meet the standard requirement on pressure difference and about four percent of measured IVCs fail to meet the requirement on air tightness in RB/T 199-2015.Now, the on-site leakage detection of HEPA filters for air supply and exhaust of IVC mainly adopts total efficiency method, but photometer total efficiency leakage detection can avoid the influence of downstream fan dust, with a bright application prospect.
Keyword：
high-level biosafety laboratory; individually ventilated cage; test; performance index; air change rate; pressure difference;
Received： 2017-08-04
参考文献
[1]
CORNING B F, LIPMAN N S.A comparison of rodent caging systems based onmicroenvironmental parameters[J].Lab Animal Sci, 1991, 41 (5) :498-503
[2]
LIPMAN N S, CORNING B F, SAIFUDDIN M.Evaluation of isolator caging systems for protection of mice against challenge with mouse hepatitis virus[J].Lab Animals, 1993, 27 (2) :134-140
[3]
HOGLOUD A U, RENSTROM A.Evaluation of individually ventilated cage systems for laboratory rodents:cage environment and animal health aspects[J].Lab Animals, 2001, 35 (1) :51-57
[4]
The International Organization for Standardization.Safety of machinery—general principles for design—risk assessment and risk reduction:ISO 12100:2010[S], 2010
[5]
European Communities.Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms[S], 1990
[6]
European Communities.Council Directive 98/81/EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms[S], 1998
[7]
全国实验动物标准化技术委员会.实验动物环境及设施:GB 14925—2010[S].北京:中国标准出版社, 2011
[8]
中国建筑科学研究院.实验动物设施建筑技术规范:GB 50447—2008[S].北京:中国建筑工业出版社, 2008:5-7
[9]
中国建筑科学研究院, 江苏双楼建设集团有限公司.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, 2012:34-38
[10]
中国国家认证认可监督管理委员会.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, 2016:3-5
[11]
江苏省质量技术监督局.江苏省地方标准 (DB22/T972—2006) :实验动物笼器具独立通气笼盒 (IVC) 系统[J].实验动物科学, 2007, 24 (3) :39-41
[12]
江苏省质量技术监督局.江苏省地方标准 (DB22/T1216—2008) :实验动物笼器具隔离器[J].实验动物科学, 2009, 26 (2) :38-41
[13]
张彦国.生物安全实验室严密性分析[J].暖通空调, 2014, 44 (1) :97-100
[14]
曹冠朋, 冯昕, 路宾.高效空气过滤器现场检漏方法测试精度比较研究[J].建筑科学, 2015, 31 (6) :145-151
[15]
曹冠朋.生物安全实验室隔离装备排风高效现场检漏方法研究[D].北京:中国建筑科学研究院, 2015:77-79
作者简介：曹国庆 100013北京市北三环东路30号环能院 (010) 64693447E-mail:cgq2000@126.com
收稿日期：2017-08-04
基金： “十三五”国家重点研发计划“高等级病原微生物实验室生物安全防护技术与产品研究”课题“实验室生物安全设备的现状分析与发展战略研究” (编号:2016YFC1201405) ;
Product and standard overview of biosafety isolating equipment-IVC and field test results
Cao Guanpeng Cao Guoqing Chen Yong Wang Rong
China Academy of Building Research
Abstract：
According to the actual demand of IVC field test for high-level biosafety laboratory, analyses the existing IVC field test methods and evaluation standards, and presents the survey results of field test and check of IVC performance indices.The results show that the products of overseas brands are widely used in laboratory while some domestic brands involve in, the air change rates of different IVCs range from 20 to 100 times per hour or even more, without insufficient air change rate, about nine percent of IVCs fail to meet the standard requirement on pressure difference and about four percent of measured IVCs fail to meet the requirement on air tightness in RB/T 199-2015.Now, the on-site leakage detection of HEPA filters for air supply and exhaust of IVC mainly adopts total efficiency method, but photometer total efficiency leakage detection can avoid the influence of downstream fan dust, with a bright application prospect.
Keyword：
high-level biosafety laboratory; individually ventilated cage; test; performance index; air change rate; pressure difference;
Received： 2017-08-04
参考文献
[1]
CORNING B F, LIPMAN N S.A comparison of rodent caging systems based onmicroenvironmental parameters[J].Lab Animal Sci, 1991, 41 (5) :498-503
[2]
LIPMAN N S, CORNING B F, SAIFUDDIN M.Evaluation of isolator caging systems for protection of mice against challenge with mouse hepatitis virus[J].Lab Animals, 1993, 27 (2) :134-140
[3]
HOGLOUD A U, RENSTROM A.Evaluation of individually ventilated cage systems for laboratory rodents:cage environment and animal health aspects[J].Lab Animals, 2001, 35 (1) :51-57
[4]
The International Organization for Standardization.Safety of machinery—general principles for design—risk assessment and risk reduction:ISO 12100:2010[S], 2010
[5]
European Communities.Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms[S], 1990
[6]
European Communities.Council Directive 98/81/EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms[S], 1998
[7]
全国实验动物标准化技术委员会.实验动物环境及设施:GB 14925—2010[S].北京:中国标准出版社, 2011
[8]
中国建筑科学研究院.实验动物设施建筑技术规范:GB 50447—2008[S].北京:中国建筑工业出版社, 2008:5-7
[9]
中国建筑科学研究院, 江苏双楼建设集团有限公司.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, 2012:34-38
[10]
中国国家认证认可监督管理委员会.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, 2016:3-5
[11]
江苏省质量技术监督局.江苏省地方标准 (DB22/T972—2006) :实验动物笼器具独立通气笼盒 (IVC) 系统[J].实验动物科学, 2007, 24 (3) :39-41
[12]
江苏省质量技术监督局.江苏省地方标准 (DB22/T1216—2008) :实验动物笼器具隔离器[J].实验动物科学, 2009, 26 (2) :38-41
[13]
张彦国.生物安全实验室严密性分析[J].暖通空调, 2014, 44 (1) :97-100
[14]
曹冠朋, 冯昕, 路宾.高效空气过滤器现场检漏方法测试精度比较研究[J].建筑科学, 2015, 31 (6) :145-151
[15]
曹冠朋.生物安全实验室隔离装备排风高效现场检漏方法研究[D].北京:中国建筑科学研究院, 2015:77-79
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