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手术单手术衣阻隔性能检测仪器准确性验证设计

Accuracy Verification Design of the Testing Instrument for the Barrier Performance of Surgical Drapes and Surgical Gowns
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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
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二级参考文献3

  • 1YY/T0506.1-2005《病人、医护人员和器械手术单、手术衣和洁净服第1部分:制造厂处理场和产品的通用要求》(修改采用EN13795—1,2002)
  • 2ISO 22612, 2005 《Clothing for protection against infectious agents-Test method for resistance to dry microbial penetration》
  • 3EN ISO 22610, 2006 《Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment-Test method to determine the resistance to wet bacterial penetration》

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