After wearing the mask, it should cover the wearer's mouth, nose to jaw. It shall conform to the designed dimensions, and the maximum deviation shall not exceed ± 5%.
The mask shall be equipped with a nose clip made of plastic material.
The length of nose clip shall not be less than 8.0cm.
The mask belt should be easy to wear and take.
The breaking strength of each mask belt at the connection point of the mask body shall not be less than 10N.
Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency of the mask shall not be less than 95%（ (same as the bacterial filtration efficiency in YY 0469-2011 medical surgical mask)
The gas flow rate of bacterial filtration efficiency test is controlled at 28.3l/min. The strain used is Staphylococcus aureus ATCC 6538, and the average particle diameter (MPS) of bacterial aerosol is (3.0 ± 0.3) μ m。
The ventilation resistance of gas exchange on both sides of the mask shall not be greater than 49pa / cm ³。
The ventilation resistance test shall be conducted at the center of the mask. The gas flow for the test shall be adjusted to (8 ± 0.2) l / min, the diameter of the sample test area is 25mm, and the test area of the test sample is a. Measure the differential pressure on both sides of the mask with a differential pressure gauge or equivalent equipment according to the formula Δ P = m / A to calculate ventilation resistance.
Δ P -- pressure difference per square centimeter of test sample, unit: PA / cm ³）；
M -- pressure difference of test sample, unit: Pa;
A - test area of test sample, unit: cm2.
The non sterile mask shall meet the following requirements: total bacterial colony (CFU / g): ≤ 100; Coliform, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus and fungi shall not be detected.
The sterilization mask shall be sterile.
Ethylene oxide residue
If the mask is sterilized or disinfected with ethylene oxide, the residual amount of ethylene oxide shall not exceed 10% μ g/g。
Cytotoxicity: the cytotoxicity of the mask shall not be greater than grade 2.
Skin irritation: the primary irritation score of the mask shall not be greater than 0.4.
Delayed type hypersensitivity: the delayed type hypersensitivity of the mask shall not be greater than grade 1.