1 Product model / specification and division description
1.1 Division description
The product is composed of mask body, nose clip and mask belt. The mask body is composed of non-woven fabric and filter material (polypropylene melt blown fabric) as the main raw material. The product is provided in non sterile form, and its performance meets the requirements of disposable medical mask (YY / T 0969-2013). The primary packaging materials are packed in PE bags of 10 pieces / bag.
1.2 Model and specification
According to the shape of the mask body, the model is divided into plane ear hook type, and the specification is 17.5cm×9.5cm，Three layer structure。
2 Performance index
2.1 Appearance
The appearance of the mask shall be neat and in good shape, and there shall be no damage or stain on the surface。
2.2 Structure and dimensions
After wearing the mask, it should be able to cover the mouth, nose and jaw of the wearer. The number of mask layers shall be consistent with the mark, and the size deviation shall not exceed ± 5%。
2.3 Nose clip
2.3.1 The mask shall be equipped with a nose clip made of plastic material.
2.3.2The length of nose clamp shall not be less than 8.0cm.
2.4 Mask belt
2.4.1 The mask belt should be easy to wear.
2.4.2 The breaking strength at the connection point between each mask belt and the mask body shall not be less than 10N.
2.5 Bacterial filtration efficiency（BFE）
The bacterial filtration efficiency of the mask shall not be less than 95%。
2.6 Ventilation resistance
The ventilation resistance of gas exchange between two sides of respirator shall not be greater than 49pa / cm2。
2.7Microbial index
Total bacterial colonies CFU/g | Coliform | Pseudomonas aeruginosa | Staphylococcus aureus | Hemolytic streptococcus | fungus |
≤100 | No detection | No detection | No detection | No detection | No detection |
3 Inspection method
3.1 Appearance
Randomly select 3 samples for test and visual inspection, which shall meet the requirements of 2.1.
3.2 Structure and dimensions
Randomly select 3 samples for test, actually wear them, cut open the mask to check the number of layers, and measure them with general or special measuring tools, which shall meet the requirements of 2.2.
3.3 Nose clip
3.3.1 Randomly select 3 samples for test, check the nose clip material and bend it by hand, all of which shall meet the requirements of 2.3.1.
3.3.2 Randomly select 3 samples for test, take out the nose clamp and measure with general or special measuring tools, all of which shall meet the requirements of 2.3.2.
3.4 Mask belt
3.4.1 Randomly select 3 samples for test, and check the adjustment condition through wearing, which shall meet the requirements of 2.4.1.
3.4.2 Three samples were randomly selected for the test and measured with 10N static tension for 5S. The results should meet the requirements of 2.4.2.
3.5 Bacterial filtration efficiency（BFE）
Three samples were randomly selected for test according to the bacterial filtration efficiency test method in YY 0469-2011, and the results should meet the requirements of 2.5.
3.6 Ventilation resistance
According to the method in YY / T 0969-2013, the test results shall meet the requirements of 2.6.
3.7 Microbial index
The test shall be conducted according to the method specified in Appendix B of GB 15979-2002, and the results shall meet the requirements of 2.7.