口罩要做的EN14683检测是什么?
我公司专业办理医疗产品出口欧盟、美国、中东南美等国家的各种认证:
贝斯通(贝斯通)检测,SGS等CE认证(MDD/MDR法规),全套CE技术文件编订, CE第四版临床评价(MEDDEV 2.7.1 Rev 4)编写,欧盟授权代表,欧盟自由销售证书,ISO13485:二016,医疗器械单一审核程序(MDSAP)审核、美国FDA注册(含FDA510K申请),FDA美国代理人服务/ FDA QSR820验厂辅导及整改,FDA警告信应对&RED LIST REMOVAL/QSR820体系辅导/OTC验厂辅导及整改,英国BRC认证咨询,BSCI验厂辅导;口罩NELNSON(尼尔森)检测:(EN 14683检测、BFE检测,VFE检测、PFE检测)、手术衣EN13795测试、防护服type5/6 (PPE认证咨询(89/686/EC个人防护指令辅导)。
欧盟标准 EN 14683
This standard is intended to help facilitate the choice of surgical face masks in the European Market by standardizing the information and performance data required for the masks.
本标准旨在利用标准化的信息和口罩的性能数据来帮助欧盟市场方便的选择外科口罩。
There are three test methods used to classify surgical masks:
有三种测试方法用来给外科口罩进行分类:
1. Bacterial Filtration Efficiency in vitro (BFE) (ASTM F2101-07)
体外细菌过滤率(BFE)(ASTM F2101-07)
• Test is used to determine the amount of infective agent that is retained by the surgical facemask, which is directly related to the amount of bacteria released through the mask into the air of the surgical theatre.
评论前必须登录!
注册