防疫型防护服的欧盟、美国与中国市场准入要求差异分析  

Differential analysis of access requirements for epidemic-prevention protective clothing in EU,America and China Markets

作　　者：鲍萍 苏健 郭长春 徐岑玲 BAO Ping;SU Jian;GUO Changchun;XU Cenling(SGS-CSTC Standards Technical Services(Shanghai)Co.,Ltd.,Shanghai 200233,China;SGS-CSTC Standards Technical Services Co.,Ltd.,Hangzhou Branch,,Hangzhou 310052,China;SGS-CSTC Standards Technical Services(Qingdao)Co.,Ltd.,Qingdao 266101,China)

机构地区：[1]通标标准技术服务(上海)有限公司,上海200233 [2]通标标准技术服务有限公司杭州分公司,浙江杭州310052 [3]通标标准技术服务(青岛)有限公司,山东青岛266101

出　　处：《纺织检测与标准》2022年第2期1-7,11,共8页Textile Testing and Standard

摘　　要：欧盟、美国和中国市场对防疫型防护服的准入要求各不相同。以医用一次性防护服、手术衣/手术服和洁净服/隔离服为对象,分析了欧盟、美国和中国市场的监管法规、风险等级、涉及相关标准以及认证要求的差异,并重点对比了各类防疫型防护服的关键技术指标和要求,有助于防疫型防护服生产企业梳理并了解三个市场的准入要求,使其产品快速合规进入相关目标市场;同时为中国标准达到“同线、同标、同质”的目标并逐步走向国际市场提供强有力的技术支撑。The EU,America and China markets have different access requirements for epidemic-prevention protective clothing.Taking single-use protective clothing for medical use,surgical gowns and clean air suits/isolation gowns as examples,the differences in access requirements including regulatory regulations,risk levels,relevant standards and certification requirements in EU,America and China have been analysed,and the key technical indexes and requirements of various epidemic-prevention protective clothing are emphatically compared.It is helpful for epidemic-prevention protective clothing manufacturers to sort out and understand the access requirements of the three markets,so that their products can quickly enter the relevant target markets in compliance.At the same time,it provides strong technical support for Chinese standards to achieve the goal of"Same line,Same standard and Same quality"and gradually move towards the international markets.

关 键 词：防疫型防护服 准入要求 中国 欧盟 美国 差异分析 

分 类 号：TS101.9[轻工技术与工程—纺织工程]