办理医用口罩的EN14683检测报告需要多久 口罩CE认证
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1：新MDR法规和MDD指令的欧盟CE认证，CE*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
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 of surgicalface masks in the European Market by standardizing the information 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。
尼尔森检测， 尼尔森认证，NELNSON检测，NELNSON认证，EN 14683检测，EN 14683认证
口罩尼尔森检测， 口罩尼尔森认证，口罩NELNSON检测，口罩NELNSON认证，口罩EN 14683检测，口罩EN 14683认证
Nelson报告，Virus Filtration Efficiency (VFE)测试
Nelson检测，Virus Filtration Efficiency 测试 - VFE检测
Nelson检测，Virus Filtration Efficiency 测试 - 口罩VFE检测
我公司是做：
1：新MDR法规和MDD指令的欧盟CE认证，CE*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
EUROPEAN STANDARD EN 14683
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.
? 这个测试是用来确定外科口罩上残留的源，此源直接影响到手术室空气中由口罩中释放出的数目。
? To test, a controlled flow of air containing an aerosol with a controlled concentration of Staphylococcus aureas is driven through a sample of the surgical mask containing all layers. The average size of the aerosol droplets is around 3.0 Micron. The number of bacteria that passes the sample is compared to the number that passes without the mask sample.
? 测试方法：使用一个喷雾装置，用来释放出固定流量的空气流，这个空气流包含着一定浓度的金葡萄球菌，让这股空气流穿过包含所有层的外科口罩。喷雾口的平均尺寸为3微米。通过样品的数目和没有样品时的数目进行比较。
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) (ASTM F2101-07)
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 potentially contaminated fluid splashes.
尼尔森检测， 尼尔森认证，NELNSON检测，NELNSON认证，EN 14683检测，EN 14683认证
口罩尼尔森检测， 口罩尼尔森认证，口罩NELNSON检测，口罩NELNSON认证，口罩EN 14683检测，口罩EN 14683认证
Nelson报告，Virus Filtration Efficiency (VFE)测试
Nelson检测，Virus Filtration Efficiency 测试 - VFE检测
Nelson检测，Virus Filtration Efficiency 测试 - 口罩VFE检测
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 of surgicalface masks in the European Market by standardizing the information 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。
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 the facemask.
? 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 of the surgical mask containing all layers. The pressure before and after the sample is measured; the difference in pressure is divided by the surface (in cm2) of the sample.
? 测试方法：使用一股定量的气流通过包含所有层的外科口罩样品。测量通过样品之前和之后的压力，这个不同的压力值再除以口罩的表面积（cm2）。
? A lower breathing resistance indicates a better comfort level for the user. It means the mask feels cooler and easier to breath through, and that the mask will maintain its shape in a better way as there is less pressure on the material. There will be less unfiltered air escaping around the mask.
? 一个较低水平的呼吸阻抗值说明使用者使用起来更舒服。说明口罩戴起来感觉更加凉爽和更容易呼吸，因为在材料上面的压力较小，所以口罩更容易保持不变形。这样还能减少从口罩边缘呼出的未经过滤的气体。
Classification:
分类
? TYPE I & II (non splash resistant) = < 3.0 mmH2O/cm2
? 类别I&II（非防溅）= < 3.0 mmH2O/cm2
? TYPE IR & IIR (splash resistant) = < 5.0 mmH2O/cm2
? 类别IR&IIR（防溅）= < 5.0 mmH2O/cm2
? The breathing resistance is always measured per square centimeter of material. One way to increase comfort is to have a low breathing resistance value per cm2, the other to enlarge the surface of the facemask and thereby the total area available for ventilation.
? 呼吸阻抗通常是用来测量每平方厘米材料上的值。一个增加舒适性的方法就是降低每平方厘米的呼吸阻抗，另外的一个方法就是通过增大口罩的表面积来增大口罩的可过滤的区域。
3. Splash Resistance (ASTM F1862-07)
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 potentially contaminated fluid splashes.
? 这种测试是用来确定对潜在污染流飞溅的穿透阻碍作用。
? To test, a precisely determined quantity of specially prepared artificial blood is sprayed at a controlled pressure against a sample of the mask. Frequently these tests are done at pressures of 80, 120 and 160 mmHg. A visible inspection on the backside of the sample indicates if there is a fluid strike-through (red color) or not. The test is repeated 32 times at each pressure, and if three or less masks show a strike through, the product is considered splash resistant at that pressure.
? 测试方法：精确定量的人造血液在固定的压力下面通过样品口罩进行喷洒。常用的测试压力一般为80，120和160mmHg。可以通过观察样品口罩背面的是否有通过的液体的痕迹（红颜色）来判断。这个测试在每个压力条件下重复32次，3次以下的液体渗出，就可以判断产品在此压力下具有防溅性能。
? A higher splash resistance means the mask will protect the user in a better way against splashes of potentially contaminated fluid during a surgical procedure.
? 一个较高的防溅性能意味着这个口罩可以更好的保护在手术中使用者不受潜在的污染液体飞溅的侵害。
Classification:
分类：
? TYPE I & TYPE II not applicable
? 类别I和类别II不适用
? TYPE IR & TYPE IIR minimum 120 mmHg
? 类别IR和类别IIR至少为120mmHg
? 120 mmHg is a minimum value. It corresponds to the average systolic arterial blood pressure, and intends to protect against ruptures in small arteries causing small sprays of blood. Some products off protection even in excess of the 120 mmHg.
? 120 mmHg是个小的值。这个值和平均的收缩压相一致，用来防止由于小型动脉的破裂造成的小规模的血液飞溅。一些产品的保护级别甚至**过了120mmHg。
Minimum Performance Requirements According to the New Facemask Standard EN14683
依据新的口罩的标准EN14683而定的的性能要求
EU Standard Class
欧盟标准分类 Bacterial Filtration Efficiency
过滤率 Breathing Resistance
呼吸阻抗
(mmH2O/cm2) Splash Resistance
防溅能力
(mmHg)
I 95% < 3.0 NA
IR 95% < 5.0 120
II 98% < 3.0 NA
IIR 98% < 5.0 120
