Disposable medical masks are suitable for covering the mouth, nose and jaw of the user. They are used to wear and block the exhalation or emission of pollutants from the mouth and nose in the general medical environment.The bacterial filtration efficiency of the mask should be no less than 95%.Not applicable to medical protective masks, medical surgical masks.

Appearance

The appearance of the mask should be clean and in good shape. The surface should not be damaged or stained.

Structure and dimensions

After wearing the mask, it should cover the wearer's mouth, nose and jaw.Should conform to the design size, the maximum deviation should not exceed ±5%.

Nose clip

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

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

Masks Belt

The mask belt should be worn easily.

The breaking strength of each mask worn at the junction of the mask body should not be less than 10N.

Bacterial filtration efficiency (BFE)

The bacterial filtration efficiency of the mask should be no less than 95%.(Same as the bacterial filtration efficiency in YY 0469-2011 Surgical Masks)

The gas flow rate of bacterial filtration efficiency test was controlled at 28.3L/min. The bacterial strain was Staphylococcus aureus ATCC 6538. The average particle diameter (MPS) of the bacterial aerosol was (3.0±0.3) m.

Ventilation resistance

The ventilation resistance of gas exchange on both sides of the mask should not be greater than 49Pa/cm.

For ventilation resistance test, take the center part of the mask for testing. The gas flow for the test should be adjusted to (8±0.2) L/min, the diameter of the sample test area should be 25mm, and the test area of the sample should be A.Mask was determined by differential pressure gauge or equivalent equipment pressure difference on both sides, according to the formula Δ P = M/A ventilation resistance calculation.

Δ P - test samples per square centimeter area of pressure difference, the unit to per square centimeter (Pa/cm after);

M -- Pressure difference value of test sample in Pa;

A -- Test area of the test sample, in square centimeters.

Microbial index

Non-sterilizing masks shall meet the following requirements:

Total bacterial colony (CFU/g) : ≤100;

Coliform group, pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus and fungus, etc. : cannot detect.

Sterilization masks should be sterile.

Residual ethylene oxide

If the mask is sterilized or disinfected with ethylene oxide, the residue of ethylene oxide should not exceed 10 g/g.

Biological evaluation

Cytotoxicity: The cytotoxicity of the mask should not be greater than level 2.

Skin irritation: The score for primary irritation of the mask should not be greater than 0.4.

Delayed hypersensitivity: The delayed hypersensitivity of the mask should not be greater than level 1.