民用口罩tuv测试报告办理流程

口罩EN14683检测，口罩VFE检测，口罩PFE检测
EUROPEANSTANDARD EN 14683
欧盟标准 EN 14683
This standardis intended to help facilitate the choice ofsurgicalface masks in the European Market by standardizing theinformation andperformance 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 threetest 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. BacterialFiltration Efficiency in vitro (BFE) (ASTMF2101-07)
体外过滤率（BFE）（ASTM F2101-07）
Classification:
分类
BFE => 95% TYPE I
BFE => 98% TYPE II
2. BreathingResistance (Delta P)
呼吸阻抗 它是指气体在流经呼吸道及呼吸装置时的耗功加总值。
3. SplashResistance (ASTMF1862-07)
防溅阻力 指防止血液\体液等溅撒 物的阻止能力.
Test is used to determine the resistance penetration of potentiallycontaminated fluid splashes.

我公司是做：
1：新MDR法规和MDD指令的欧盟CE认证，CE第四版临床评价报告更新/编写
2：欧盟自由销售证书，欧盟授权代表（德国，荷兰，英国），
3：ISO9001/ISO13485认证以及咨询辅导
4：FDA注册，FDA510K，FDA验厂辅导/陪审和翻译
5：MDSAP咨询辅导，国内注册证，生产许可证的办理
• A higher BFE percentage indicates a better protection level forthe patient against infective agents from the OR staff.
• 这个BFE比值越高，说明口罩能更好的保护病人不易因为手术人员而感染。
Classification:
分类
• BFE => 95% TYPE I
• BFE => 98% TYPE II
• A different BFE test called the "Modified Green & Vesley" or BFEin vivo has been used frequently in the past. This test methodalways provides extremely high values, but does not reallydifferentiate between different quality surgical facemasks. The BFEin vivo test method is therefore not part of the new EUstandard.
•不同的BFE测试可以称为“修改版的Green&Vesley”或者体外BFE，这种方法在过去经常被使用。这种测试方法能提供极高的值，但并不真正的区分出不同质量外科口罩。这种体外BFE测试方法没有成为新的欧盟标准的一部分。
2. Breathing Resistance (Delta P)　
呼吸阻抗　它是指气体在流经呼吸道及呼吸装置时的耗功加总值。
• Test is used to determine the resistance airflow of thefacemask.
• 这种测试来确定口罩的气流阻力。
• To test, a controlled flow of air is driven through a sample ofthe surgical mask containing all layers. The pressure before andafter the sample is measured; the difference in pressure is dividedby the surface (in cm2) of the sample.