出口欧盟一次性医用口罩EN14683防溅阻力检测

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：

TUV莱茵，TUV南德，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.

• 这个测试是用来确定外科口罩上残留的传染源，此传染源直接影响到手术室空气中由口罩中释放出的细菌数目。

• 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黄色葡萄球菌，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。通过样品的细菌数目和没有样品时的细菌数目进行比较。

• A higher BFE percentage indicates a better protection level for the 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 BFE in vivo has been used frequently in the past. This test method always provides extremely high values, but does not really differentiate between different quality surgical facemasks. The BFE in vivo test method is therefore not part of the new EU standard.

• 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测试方法因此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 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。

• 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。

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超过了120mmHg。

Minimum Performance Requirements According to the New Facemask Standard EN14683

依据新的口罩的标准EN14683而定的低的性能要求

EU Standard Class

欧盟标准分类 Bacterial Filtration Efficiency

细菌过滤率 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