摘要
阻湿态微生物穿透试验仪的应用场景是测试手术单、手术衣和防护服在受机械摩擦时对液体携带细菌穿透的屏障特性。文章通过均匀性和对照材料测试进行表征,验证阻湿态微生物穿透试验仪稳定性和试验方法的一致性。均匀性测试中,在对几种耗材进行筛选测试后,试验指和转盘同时运动,通过复写纸在白纸上留下的清晰痕迹,使均匀性测试呈现的效果更好。对照材料测试中,寻找到标准要求的对照材料后,依据样品测试的流程,参照国内外标准的要求,对对照材料测试了35次,使试验结果R_(CUM5)满足0.7~0.96。同时对试验中的影响因素进行了探究与摸索,方便试验人员在操作中规避一些误区。文章包含大量的试验数据和对试验影响因素的总结,通过均匀性测试和对照材料测试试验,使开展试验的人员对仪器的稳定性和数据准确性作出明确判断。
The application scenario of the moisture barrier microbial penetration tester is to test the barrier properties of surgical drapes,surgical gowns and protective clothing against the penetration of liquid-carrying bacteria when subjected to mechanical friction.In this paper,the uniformity and control material tests are used to characterize the stability of the moisture barrier microbial penetration tester and the consistency of the test method.In the uniformity test,after the screening test of several consumables,the test finger and the turntable move at the same time,and the clear traces left by the carbon paper on the white paper make the uniformity test more effective.In the control material test,after finding the reference material required by the standard,according to the sample test process,referring to the requirements of domestic and foreign standards,the reference material was tested 35 times,so that the test result R_(CUM5) satisfies the range of 0.7-0.96.At the same time,the influencing factors in the experiment are explored and explored,which is convenient for the experimenters to avoid some misunderstandings in the operation.This article contains a large amount of experimental data and a summary of the experimental influencing factors.Through the uniformity test and the control material test experiment,the personnel conducting the experiment can make a clear judgment on the stability of the instrument and the accuracy of the data.
作者
李晓彤
秦丹
贺强强
何春雷
刘超
张旭
王坤
邵连维
LI Xiao-tong;QIN Dan;HE Qiang-qiang;HE Chun-lei;LIU Chao;ZHANG Xu;WANG Kun;SHAO Lian-wei(Qingdao Junray Intelligent Instrument Co.,Ltd.,Shandong Qingdao 266109)
出处
《中国医疗器械信息》
2023年第5期63-66,80,共5页
China Medical Device Information
关键词
阻湿态
手术单
手术衣
防护服
微生物穿透试验仪
moisture-resistant state
surgical drape
surgical gown
protective clothing
microbial penetration tester