2020年新疆地区部分检测隔离衣质量结果分析  

Analysis of Quality Results of Partial Inspection of Isolation Clothing in Xingjiang in 2020

作　　者：古丽巴哈尔·托乎提 艾山·艾比布勒 孙鹏 热孜宛古丽·伊敏 张树文 赵微 李海芳 GULIBAHAER·Tuohuti;AISHAN·Aibibule;SUN Peng;REZIWANGULI·Yimin;ZHANG Shuwen;ZHAO Wei;LI Haifang(Food and Drug Inspection Institute of Xinjiang Uygur Autonomous Region;Disease Control and Prevention Centre of Xinjiang Uygur Autonomous Region)

机构地区：[1]新疆维吾尔自治区药品检验研究院医疗器械检验研究室 [2]新疆维吾尔自治区疾病预防控制中心消毒感染控制中心

出　　处：《中国标准化》2023年第9期189-191,共3页China Standardization

摘　　要：为根据2020年监督、委托等检验情况对部分检测隔离衣进行结果统计,了解本地区监督、委托检验的隔离衣质量状况,为医疗器械监督管理部门提供科学依据。方法:参照GB19082-2009标准方法,对本地区监督、委托等检验的38批隔离衣产品根据相应产品技术要求进行尺寸、外观-缝制、单位面积质量、抗渗水性、表面抗湿性、断裂强力、断裂伸长率、透湿量、过滤效率、微生物指标等的检测。结果:38批产品中1批断裂强力不合格,2批过滤效率不合格。结论:38批产品经检验发现不同企业产品技术要求中的条款和限值存在较大差异,存在一定的安全隐患。建议相关部门对隔离衣产品开展技术要求提高工作,对技术要求中个别条款标准不一致、制定标准过低等情况,统一进行规范化修改,确保产品技术要求可有效控制质量。Objective:To make statistic analysis of the results of partial inspection of isolation clothing according to the supervision and entrusted inspection in 2020,understand the quality condition of isolation clothing supervised and inspected in this area,and provide the scientific basis for medical device supervision and administration department.Methods:According to the method of GB 19082-2009 standard,the size,appearance-sewing,unit area quality,water resistance,surface moisture resistance,breaking strength,elongation at break,moisture permeability,filtration efficiency,microbial index of 38 batches of isolating clothing products inspected in Xinjiang were tested according to the technical requirements for the corresponding products.Result:One of the 38 batches of products is not qualified for fracture strength and the filtration efficiency of two batches are not qualified.Conclusion:According to the inspection of 38 batches of products,it is found that the terms and limits in the technical requirements of enterprises are different,and there is hidden danger in safety.It is suggested that the relevant departments should improve the technical requirements of the isolated clothing products,and make standardized modifications to ensure that the technical requirements of the products can effectively control the quality.

关 键 词：隔离衣 产品技术要求 结果分析 质量安全 

分 类 号：F203[经济管理—国民经济] F426.86[轻工技术与工程—服装设计与工程] TS941.79