Technical requirements and inspection methods of disposable medical masks

- Jul 17, 2020-

disposable medical masks

01 appearance


Technical requirements: the appearance of the mask should be clean and tidy, and the surface should not be damaged or stained.


Test method: three samples are used for inspection and visual inspection, which shall meet the above requirements.


02 structure and dimensions


Technical requirements: after wearing the mask, it should cover the wearer's mouth, nose and mandible. The maximum deviation shall not exceed ± 5%.


Test method: three samples are randomly selected for inspection, and they are actually worn and measured with general or special measuring tools, which should meet the above requirements.


03 nose clip


Technical requirements:

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

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


Test method:

1) Three samples were randomly selected for inspection. Check the material of nose clip and bend it by hand, which should meet the above technical requirements.

2) Three samples were randomly selected for inspection. Take out the nose clip and measure with general or special measuring instrument. The length of nose clip should not be less than 8.0 cm.


04 mask belt


Technical requirements:

1) Masks should be easy to wear and take.

2) The breaking strength of the joint between each mask belt and the mask body should not be less than 10N.


Test method:

1) Three samples were randomly selected for inspection, and their adjustment conditions were checked by wearing, which should meet the above technical requirements.

2) Three samples were randomly selected for inspection, and the static tensile force of 10N was measured for 5S. The results should meet the above technical requirements.


05 bacterial filtration efficiency (BFE)


Technical requirements:

The bacterial filtration efficiency of the mask should not be less than 95%.


Test method:

Three samples were randomly selected and tested according to the bacterial filtration efficiency test method in YY 0469, and the results should be consistent with the filtration efficiency not less than 95%.


06 ventilation resistance


Technical requirements:

The ventilation resistance of the two sides of the mask for gas exchange should not be greater than 49 PA / cm 2.


Test method:

1) Three samples were randomly selected for inspection;

2) Test part: take the central part of the mask for inspection;


Inspection process: the gas flow rate for inspection shall be adjusted to (8 ± 0.2) l / min, the diameter of sample inspection area shall be 25 mm, and the inspection area of test sample shall be a. The pressure difference between the two sides of the mask was measured by differential pressure meter or equivalent equipment, and the ventilation resistance was calculated according to formula (1). The results should be consistent with that the ventilation resistance should not be greater than 49 PA / cm 2.

Formula (1): △ P = m / A

Δ P -- pressure difference value per square centimeter area of test sample, unit: PA / cm 2;

M -- pressure difference of test sample, unit: Pa;

A -- test area of the test sample, unit: square centimeter (cm 2).