1) Filtration efficiency: under the condition of air flow (30±2) L/min. The filtration efficiency of sodium chloride aerosol with median aerodynamic diameter (0.24±0.06) μm is not less than 30%.
2) Bacterial filtration efficiency: Under specified conditions, the filtration efficiency of Staphylococcus aureus aerosol with an average particle diameter of (3±0.3) μm is not less than 95%. The filtration rate of bacteria should be ≥95%; the filtration rate of non-oily particles should be ≥30%.
3) Breathing resistance: Under the condition of filtration efficiency and flow rate, the inspiratory resistance does not exceed 49Pa. The exhalation resistance does not exceed 29.4Pa. When the pressure difference △P between the two sides of the mask for gas exchange is 49Pa/cm, the gas flow rate should be ≥264mm/s.
4) Nose clip and mask strap: The mask should be equipped with a nose clip, and the length of the nose clip should be greater than 8.0cm. The breaking strength at the connection point of each mask belt and the mask body should be greater than 10N.
5) Synthetic blood penetration: 2ml of synthetic blood is sprayed onto the outside of the mask at a pressure of 16.0kPa. There should be no penetration on the inside of the mask.
6) Flame retardant performance: The mask material should be made of non-flammable materials. The mask burns less than 5 seconds after leaving the flame.
7) Residual ethylene oxide: Masks sterilized by ethylene oxide, the residual ethylene oxide should be less than 10μg/g.
8) Skin irritation: The primary irritation index of the mask material should be ≤0.4, and there should be no allergenic reaction.
9) Microbiological indicators: the total number of bacterial colonies ≤ 20CFU/g.
