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Exterior
The appearance of the mask should be neat and in good shape, and there should be no damage or stain on the surface.

Structure and size
After wearing the mask, it should cover the mouth, nose and jaw of the wearer. Should meet the design size, the maximum deviation should not exceed ± 5%.

Nose clip
The nose mask should be equipped with a nose clip made of plastic material.
The length of the nose clip should not be less than 8.0cm.

Mask band
Mask belts should be easy to wear.
The breaking strength of each mask at the connection point of the mask body should not be less than 10N.

Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency of the mask should not be less than 95%. (Same as the bacterial filtration efficiency in “YY 0469-2011 Medical Surgical Mask”)
The gas flow rate in the bacterial filtration efficiency test was controlled at 28.3 L / min. The strain used was Staphylococcus aureus ATCC 6538, and the average particle diameter (MPS) of its bacterial aerosol was (3.0 ± 0.3) μm.

Ventilation resistance
The ventilation resistance of the gas exchange on both sides of the mask should be no more than 49Pa / cm³.
The ventilation resistance test takes the center part of the mask for testing. The gas flow for the test needs to be adjusted to (8 ± 0.2) L / min. The diameter of the test area of ​​the sample is 25 mm. Use a differential pressure meter or equivalent equipment to measure the pressure difference between the two sides of the mask, and calculate the ventilation resistance according to the formula ΔP = M / A.
ΔP-the pressure difference per square centimeter area of ​​the test sample, the unit is Pa per square centimeter (Pa / cm³);
M ——The differential pressure value of the test sample in Pa (Pa);
A ——The test area of ​​the test sample, the unit is square centimeter (cm³).

Microbiological index
Non-sterile masks should meet the following requirements:
Total bacterial colonies (CFU / g): ≤100;
Coliform bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococci and fungi, etc .: Not detectable.
Sterile masks should be sterile.

Residue of ethylene oxide
If the mask is sterilized or sterilized by ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg / g.

Biological evaluation
Cytotoxicity: The cytotoxicity of the mask should not be greater than level 2.
Skin irritation: The primary irritation score of the mask should not be greater than 0.4.
Delayed-type hypersensitivity: The delayed-type hypersensitivity of masks should not be greater than level 1.
References

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