2022年~2023年河南省一次性使用手术衣阻干态微生物穿透情况分析  

Analysis of the Resistance to Dry Microbial Penetration in Disposable Surgical Gown in Henan Province in 2022-2023

作　　者：魏聪 陈国铭 田林奇 朱玉青 何孜翰 周静 WEI Cong;CHEN Guo-ming;TIAN Lin-qi;ZHU Yu-qing;HE Zi-han;ZHOU Jing(Henan Institute for Drug and Medical Device Inspection,Henan Zhengzhou 450008)

机构地区：[1]河南省药品医疗器械检验院,河南郑州450008

出　　处：《中国医疗器械信息》2024年第9期31-33,共3页China Medical Device Information

基　　金：河南省医用防护用品重点实验室开放课题(课题名称:阻干态微生物穿透试验研究与应用分析,课题编号:YD2021007)。

摘　　要：目的:分析2022、2023年河南省一次性使用手术衣阻干态微生物穿透检验结果,为医疗器械使用、监管提供参考。方法:按照标准YY/T 0506.5-2009中一次性手术衣阻干态微生物穿透试验检验项目,并按照该标准进行判定。结果:2022年和2023年一次性使用手术衣阻干态微生物穿透检验共进行52批。其中,合格50批次,不合格2批次。结论:近年产品质量大幅提升,合格率为96%。但手术衣质量仍具有很大提升空间,阻干态微生物穿透检测结果的关键点主要在于对手术衣原材料的质量的把控,加强手术衣生产质量控制,对产品放行严格把控,产品技术要求及时更新对照行准。Objective:Analyze the results of the dry microbiological test of disposable surgical gown in Henan Province in 2022 and 2023.Provide reference for the use and supervision of medical device.Methods:According to YY/T 0506.5-2009“Surgical drapes,Surgical gowns and Clean Clothing for Patients,Medical Personnel and Instruments Part 5:Method of the resistance to dry microbial penetration”and determine according to the standards.Results:In 2022 and 2023,a total of 52 batches of disposable surgical gown resistance microbiological tests were carried out,of which 50 batches were qualified and 2 batches were unqualified.Conclusion:In recent years,the product quality has improved significantly,with a pass rate of 96%.However,the quality of surgical gowns still has a lot of room for improvement.The key points of the detection results of dry microbial penetration are mainly:control the quality of the raw materials of surgical gowns;Strengthen the quality control of the production of surgical gowns,and strictly control the release of products;The technical requirements of the product are updated in time.

关 键 词：一次性使用手术衣 阻干态微生物穿透 防护产品 

分 类 号：TH771[机械工程—仪器科学与技术]