1. Lightweight, comfortable, odorless, free of glass fiber, non-irritating to the skin, waterproof.
2. Appearance of the soft and comfortable adjustable nose bridge clip The appearance of the mask should be neat and in good shape, and the surface should not be damaged or stained. Structure and size After the mask is worn, it should be able to cover the wearer's mouth, nose and chin. It should conform to the designed size, and the larger deviation should not exceed ±5%. Nose clip The mask should be equipped with a nose clip, which is made of plastic material. The length of the nose clip should not be less than 8.0cm. Mask straps Mask straps should be easy to wear. The breaking strength of each mask strap 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 Masks") The gas flow rate of the bacterial filtration efficiency test was controlled at 28.3L/min, the strain used was Staphylococcus aureus ATCC 6538, and the average particle size of the bacterial aerosol was The diameter (MPS) was (3.0 ± 0.3) μm. Ventilation resistance The ventilation resistance of gas exchange on both sides of the mask should not be greater than 49Pa/cm³. The ventilation resistance test takes the central part of the mask for testing. The gas flow rate for the test needs to be adjusted to (8±0.2) L/min, the diameter of the sample test area is 25mm, and the test sample test area is A. Use a differential pressure gauge or equivalent equipment to measure the pressure difference on both sides of the mask, and calculate the ventilation resistance according to the formula ΔP=M/A.
ΔP ——The pressure difference value per square centimeter of the test sample, the unit is Pa per square centimeter (Pa/cm³); M——The pressure difference value of the test sample, the unit is Pa (Pa); A——The test area of the test sample, The unit is square centimeters. Microbial indicators Non-sterile masks should meet the following requirements: Total number of bacterial colonies (CFU/g): ≤ 100; Sterilized masks should be sterile. Residual amount of ethylene oxide If the mask is sterilized or disinfected 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 grade 2. Skin irritation: The primary irritation score of the mask should not be greater than 0.4. Delayed type hypersensitivity reaction: The delayed type hypersensitivity reaction of the mask should not be greater than grade 1.
