医用外科口罩和防护口罩生物气溶胶过滤效率的评价  

Evaluation of bioaerosol filtration efficiencies of surgical masks and respirators

作　　者：刘克洋 刘思敏 王丹[2] 张娟 黄永富 李鹏 岳卫华 LIU Ke-yang;LIU Si-min;WANG Dan;ZHANG Juan;HUANG Yong-fu;LI Peng;YUE Wei-hua(No.1 Materials Department,Beijing Institute of Medical Device Testing,Beijing 101111,China;State Key Laboratory of Organic-Inorganic Composites,Beijing University of Chemical Technology,Beijing 100029,China)

机构地区：[1]北京市医疗器械检验所材料一室,北京101111 [2]北京化工大学有机无机复合材料国家重点实验室,北京100029

出　　处：《医疗卫生装备》2021年第4期50-57,共8页Chinese Medical Equipment Journal

基　　金：国家重点研发计划重点专项(2020YFC0844800)。

摘　　要：目的:对医用外科口罩和防护口罩的颗粒过滤效率(particle filtration efficiency,PFE)、细菌过滤效率(bacte-rial filtration efficiency,BFE)及病毒过滤效率(viral filtration efficiency,VFE)进行评价。方法:参照YY 0469-2011《医用外科口罩》对不同品牌医用外科口罩在不同生物气溶胶平均颗粒直径(mean particle size,MPS)、不同流量条件下进行PFE、BFE和VFE测试,并分析医用外科口罩PFE和BFE的相关性、BFE和VFE的差异以及实际佩戴+热水浸泡处理后PFE和BFE的变化。参照GB 19083-2010《医用防护口罩技术要求》和YY/T 1497-2016《医用防护口罩材料病毒过滤效率评价测试方法 Phi-X174噬菌体测试方法》对3种防护口罩进行PFE和VFE检测。采用SAS 8.2软件进行统计学分析。结果:医用外科口罩对MPS约为3 μm的气溶胶的BFE高于MPS约为2 μm的BFE;流量越高,PFE越低;对PFE较低的医用外科口罩,BFE与PFE呈现一定相关性(MPS约为2 μm 时R2=0.671 8,MPS约为3 μm 时R2=0.776 5);医用外科口罩的VFE略低于BFE;3种防护口罩的VFE>99.98%;医用外科口罩佩戴8 h后经65 ℃热水浸泡处理30 min,细菌和真菌总数降低至0~60 cfu/g;新医用外科口罩经3次热水浸泡处理后,其PFE基本未发生变化,但佩戴过的口罩经过热水浸泡处理后,PFE和BFE均出现不同程度的降低。结论:该研究可为医用外科口罩和防护口罩的科学使用和相应标准的修订提供数据支撑。Objective To evaluate the particle filtration efficiency(PFE),bacterial filtration efficiency(BFE)and viral filtration efficiency(VFE)of medical surgical and respirators.Methods The PFE,BFE and VFE of different brands of surgical mask were tested under different mean particle size(MPS)of bioaerosols and different flow rates with reference to YY 0469—2011"Medical surgical masks".The analyses were executed over the correlation between PFE and BFE of surgical mask,the differences between BFE and VFE and the changes of PFE and BFE after actual wear combined with hot water immersion.The PFE and VFE tests were carried out on three types of respirators with reference to GB 19083—2010"Technical requirements for medical protective masks"and YY/T 1497—2016"Evaluation test method for the viral filtration efficiency(VFE)of medical protective face mask materials—Test method using Phi-X174 bacteriophage".SAS 8.2 software was used for statistical analysis.Results The BFE of surgical mask for bioaerosols with MPS of about 3μm was higher than that for MPS of about 2μm;the higher the flow rate,the lower the PFE;for the surgical mask with low PFE,the BFE showed certain correlation with the PFE(R2=0.6718 for MPS of about 2μm and R2=0.7765 for MPS of about 3μm);the VFE of surgical mask was slightly lower than the BFE;the VFEs of all the three respirators were all greater than 99.98%;the total number of bacteria and fungi decreased to 0-60 cfu/g after surgical mask were worn for 8 h and then treated with hot water at 65℃for 30 min;the PFE of new surgical mask remained basically unchanged after three times of hot water soaking,while the PFE and BFE of the worn masks were both lower after hot water soaking.Conclusion Data are provided to support the scientific use of medical surgical and respirators and the revision of the corresponding criteria.

关 键 词：医用外科口罩 防护口罩 颗粒过滤效率 细菌过滤效率 病毒过滤效率 

分 类 号：R318.6[医药卫生—生物医学工程] R181.9[医药卫生—基础医学]