医用一次性防护服阻传染因子穿透性能评价  

Evaluation of performance of disposable medical protective clothing for resistance to infective agent penetration

作　　者：刘克洋 冯岩 张娟 牛悦 秦丹 黄永富 胡广勇 LIU Ke-yang;FENG Yan;ZHANG Juan;NIU Yue;QIN Dan;HUANG Yong-fu;HU Guang-yong(Beijing Institute of Medical Device Testing,Beijing Center for Testing&Research of Medical Biological Protective Equipment,Beijing 101111,China;Liaoning Institute of Medical Device Testing,Shenyang 110171,China;Qingdao Junray Intelligent Instrument Co.,Ltd.,Qingdao 266109,Shandong Province,China)

机构地区：[1]北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心),北京101111 [2]辽宁省医疗器械检验检测院,沈阳110171 [3]青岛众瑞智能仪器股份有限公司,山东青岛266109

出　　处：《医疗卫生装备》2024年第5期16-21,共6页Chinese Medical Equipment Journal

基　　金：2022年强制性国家标准制修订计划项目(20220870-Q-464)。

摘　　要：目的:对医用一次性防护服的阻传染因子穿透性能进行评价,为GB 19082修订时该类性能指标的设置提供数据支持。方法:选择10批不同品牌型号的防护服,分别按照YY/T 0700—2008、YY/T 0689—2008、YY/T 0506.6—2009、GB 19082—2009、YY/T 0506.5—2009和YY/T 1799—2020规定的方法进行抗合成血穿透、抗噬菌体穿透、阻湿态微生物穿透、颗粒过滤效率、阻干态微生物和阻污染液体气溶胶穿透实验。结果:10批次防护服中抗合成血穿透性能级别为2级、3级、4级、5级和6级的防护服各2批;抗合成血穿透性能为2级、3级、4级、5级和6级的防护服阻湿态微生物穿透性能均为最高级别6级,部分防护服抗噬菌体穿透性能级别低于抗合成血穿透性能级别;所有防护服样品颗粒过滤效率均较高(>95%),阻干态微生物穿透性能均为最高级3级;10批防护服中有5批阻污染液体气溶胶穿透性能为最高级3级,1批为2级,其余4批无法进行级别判定,但穿透后平均对数降低值均>4.5。结论:颗粒过滤效率和抗噬菌体穿透可作为GB 19082修订后的阻传染因子穿透性能要求,用于评价防护服材料对空气颗粒物和液体污染物中的微生物阻隔能力。Objective To evaluate the performance of the disposable medical protective clothing in blocking the penetration of infectious agents,in order to provide data support for the setting of such performance indexes when the GB 19082 is revised.Methods Totally 10 batches of different brands and models of protective clothing were selected,and tests were carried out for penetration resistance to synthetic blood,phage,wet microorganisms,dry microorganisms and contaminated liquid aerosol and particle filtration efficiency according to YY/T 0700—2008,YY/T 0689—2008,YY/T 0506.6—2009,GB 19082—2009,YY/T 0506.5—2009 and YY/T 1799—2020.Results There were 2 batches of protective clothing with anti-synthetic blood penetration performance level 2,3,4,5 and 6,respectively;all the protective clothing had the highest level 6 for anti-wet microorganisms penetration,part of whom had the levels for the resistance to phage penetration lower than those for preventing anti-synthetic blood penetration;all of the protective clothing had the particle filtration efficiencies higher than 95%,and had the highest level 3 for anti-dry microorganisms penetration;there're 5 batches of protective clothing with the highest level 3 for contaminated liquid aerosol penetration,1 batch with level 2 and the remained 4 batches with undetermined levels,which all had an average logarithmic reduction higher than 4.5 after penetration.Conclusion Particle filtration efficiency and resistance to phage penetration may be involved in the requirements for resistance to infective agent penetration in revised GB 19082 for evaluating the ability of protective clothing materials to block microorganisms in airborne particles and liquid contaminants.

关 键 词：医用一次性防护服 阻传染因子穿透性能 抗合成血穿透 抗噬菌体穿透 阻湿态微生物穿透 颗粒过滤效率 阻干态微生物穿透 阻污染液体气溶胶穿透 

分 类 号：R318.6[医药卫生—生物医学工程] TH771[医药卫生—基础医学]