国内外手术衣手术单标准体系比较研究及建议  

Comparison and analysis of domestic and foreign standards of surgical sheets and surgical gowns and current situation of product registration

作　　者：左芳芳 王璟琦 林卓立 徐瑶 石宇飞 江映珠 ZUO Fangfang;WANG Jingqi;LIN Zhuoli;XU Yao;SHI Yufei;JIANG Yingzhu(Guangzhou Inspection Testing and Certification Group Co.,LTD,Guangzhou,Guangdong 511447,China;Guangzhou Medical University,Guangzhou,Guangdong 511436,China;Evaluation and Inspection Center of GDMPA,Guangzhou,Guangdong 510145,China)

机构地区：[1]广州检验检测认证集团有限公司,广东广州511447 [2]广州医科大学,广东广州511436 [3]广东省药品监督管理局审评认证中心,广东广州510145

出　　处：《中国纤检》2025年第2期88-92,共5页China Fiber Inspection

摘　　要：本文采用文献分析和试验测试的方法,系统研究美国、欧盟、中国手术衣、手术单产品标准体系,重点比较了阻微生物穿透、微粒释放、生物负载,阻液体穿透、胀破强度、断裂强度等指标及测试方法的差异。结合国抽和检测数据,分析了手术衣产品不合格情况,提出了完善我国手术衣手术单标准和注册审查体系的建议。By means of literature analysis and experimental testing,this paper systematically compared the similarities and differ-ences of the standard systems of surgical clothing and surgical single products in the United States,the European Union and China,focusing on the analysis of microbial penetration resistance,particle release,biological load,liquid penetration resistance,bursting strength,breaking strength and other indicators and differences in test methods.Based on the big data,the unqualified situation of surgical clothing products was analyzed,and suggestions were put forward to improve the standard and registration evaluation sys-tem of surgical clothing in China.

关 键 词：手术衣 手术单 标准 注册 

分 类 号：TS107[轻工技术与工程—纺织工程]