HomeNewsWhat are the classifications and executive standards of medical mask?

What are the classifications and executive standards of medical mask?

2020-04-22
The masks we see in our daily life can be divided into medical protective mask, medical Surgical Mask, disposable Medical Mask and gauze mask. The first three belong to the second category of medical devices, which are included in the management of medical devices. Gauze masks are not managed as medical devices.

1.Medical protective mask
Medical protective mask conforms to the technical requirements for medical protective masks (gb19083-2010). Its main intended use is to prevent pathogens and microorganisms such as solid particles, droplets, blood and body fluids in the air. It has the highest level of protection.
2.Medical surgical mask
The medical surgical mask meets the technical requirements for medical surgical mask (YY 0469-2011). Generally, it is a mask worn by doctors to prevent splashes of body fluid during invasive operation.
3.Disposable medical mask

The disposable medical mask meets the Chinese registered product standard (yzb) or YY / t0969-2013. Wear a mask to prevent droplets and secretions in the general diagnosis and treatment environment.


The outer packaging of the mask must have clear information such as the executive standard, the scope of use, the date of production and the shelf life. The key indicators of the three kinds of mask standards in China are consistent with those in the United States and Europe. For example, medical protective mask is used to identify N95, and the filter material is the same as that of N95 in the United States. In addition, kn95 filter material is the same as N95.


According to experts, the main structure of medical masks is basically the same, with three layers of materials. The inner and outer two-layer nonwovens have the function of blocking blood and good air permeability. The middle layer is a melt blown material, which has the function of filtration and has the characteristics of water-proof and smoke-free combustion.


In order to achieve effective protection, medical mask needs to be strictly tested by multiple indicators.

Among them, the synthetic blood penetration project is to test whether the mask can effectively block by simulating the injection of human blood. Hold the respirator on a clamp, and then a blood pressure pressure will hit the outer surface of the respirator to see if there is blood penetration inside. Through this simulation experiment to determine the mask's anti synthetic blood permeability.



The filter material in the mask should be able to prevent the invasion of the virus. Another key indicator is the tightness of the mask. From the protection point of view, if the tightness is not good, it will lead to leakage. The clinical medical staff will still have the risk of biological infection when wearing it, so it is necessary to test the tightness index. This indicator is very critical. 10 subjects are selected, and the face size of the subjects is required, which is to ensure the representativeness of face shape in clinical use, so we need 5 male and 5 female subjects. In the clinical environment, the actions of turning head, shaking head and nodding, breathing and deep breathing are designed according to the possible actions in the clinical scene.

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