2020-04-08
Single-use medical face mask
Disposable medical masks are suitable for covering the user's mouth, nose, and jaw, and are used in ordinary medical environments to wear and block the mouth and nasal exhalation or spray pollutants. The bacterial filtration efficiency of the mask should not be less than 95%. Not suitable for medical protective masks, medical surgical masks.
Exterior
The appearance of the mask should be neat and intact, and there should be no damage or stain on the surface.
Structure and size
After wearing the mask, it should be able to cover the mouth, nose and jaw of the wearer. It should conform to the designed size, and the maximum deviation should not exceed ± 5%.
Nose clip
The length of the nose clip should not be less than 8.0cm.
Mask band
Mask bands should be easy to wear.
Bacterial Filtration Efficiency (BFE)
The bacterial filtration efficiency of the mask should not be less than 95%. (Same as the bacteria filtration efficiency in YY 0469-2011 Medical Surgical Mask)
The gas flow rate of the bacterial filtration efficiency test was controlled at 28.3 L / min. The strain used was S. aureus ATCC 6538, and the average particle diameter (MPS) of the bacterial aerosol was (3.0 ± 0.3) μm.
Ventilation resistance
A —— The test area of the test sample, the unit is square centimeter (cm³).
Microbial index
Sterile masks should be sterile.
Ethylene oxide residue
If the mask is sterilized or sterilized with ethylene oxide, the residual ethylene oxide should not exceed 10 μg / g.
Biological evaluation
Late-type hypersensitivity: The late-type hypersensitivity of the mask should be no greater than Grade 1.