Industry News

Single-use medical face mask

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 mask should be equipped with a nose clip made of a plastic material.

The length of the nose clip should not be less than 8.0cm.


Mask band


Mask bands 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 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


The ventilation resistance for gas exchange on both sides of the mask should not be greater than 49Pa / cm³.
The ventilation resistance test is performed at the center 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 25 mm, and the test area of the test sample is A. Use a differential pressure meter or equivalent device to measure the pressure difference on both sides of the mask, and calculate the ventilation resistance according to the formula ΔP = M / A.
ΔP ——pressure difference per square centimeter of the test sample, the unit is Pa per square centimeter (Pa / cm³);
M ——pressure difference of test sample, unit is Pa (Pa);

A —— The test area of the test sample, the unit is square centimeter (cm³).


Microbial index


Non-sterile masks should meet the following requirements:
Total number of bacterial colonies (CFU / g): ≤100;
Coliform bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus and fungi: shall not be detected.

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


Cytotoxicity: The cytotoxicity of the mask should be no greater than Grade 2.
Skin irritation: The primary irritation score for the mask should be no greater than 0.4.

Late-type hypersensitivity: The late-type hypersensitivity of the mask should be no greater than Grade 1.