Classification of medical masks

Medical masks include medical surgical masks, medical protective masks and disposable medical masks. Medical mask can not only be virus pathogen but also dust-proof, and it is the basic medical protection equipment



Medical masks approved for listing as medical devices include medical protective masks, medical surgical masks and general medical masks, while ordinary degreasing gauze masks are not managed as medical devices. As a medical device approved medical mask, the performance of the mask is very different from that of the ordinary dust mask. The important technical indexes and application scope of the mask approval standard are as follows:

Medical mask

It meets the standard of gb19083-2010 technical requirements for medical mask, and important technical indexes include filtration efficiency and air flow resistance of non oily particles:

(1) Filtration efficiency: at air flow (85 ± 2) Mean aerodynamic diameter (0.24) at l/min ± 0.06） μ The filtration efficiency of M sodium chloride aerosol shall not be less than 95%, which means that it conforms to N95 (or FFP2) and above.

(2) Suction resistance: under the above flow conditions, the suction resistance shall not exceed 343.2pa (35mmh2o).

Medical mask is suitable for medical personnel and related staff to protect air-borne respiratory infectious diseases, with high protection level.

surgical mask

It meets the technical requirements for medical surgical mask (yy0469-2011), and the important technical indexes include filtration efficiency, bacterial filtration efficiency and respiratory resistance:

(1) Filtration efficiency: at air flow (30 ± 2) Mean aerodynamic diameter (0.24) at l/min ± 0.06） μ The filtration efficiency of M sodium chloride aerosol is not less than 30%;

(2) Filtration efficiency of bacteria: under the specified conditions, the average particle diameter is (3 ± 0.3） μ The filtration efficiency of M Staphylococcus aureus aerosol was not less than 95%;

(3) Respiratory resistance: under the condition of filtration efficiency flow, the suction resistance shall not exceed 49pa and the expiratory resistance shall not exceed 29.4pa.

Medical surgical mask is suitable for basic protection of medical personnel or related personnel, as well as prevention of blood, body fluid and splash transmission during invasive operation.

General medical mask

It meets the relevant registered product standards (yzb), generally lacks the filtration efficiency requirements for particles and bacteria, or the filtration efficiency requirements for particles and bacteria are lower than those of medical surgical masks and medical protective masks.

(1) The total number of initial contamination bacteria of non sterile mask should not exceed 100cfu/g, and no pathogenic bacteria should be detected;

(2) Sterilized mask shall be sterile, sterilized by ethylene oxide, and the residual amount shall not exceed 10 when leaving the factory μ g/g。

The protective effect of ordinary medical mask on pathogenic microorganism is not accurate, which can be used for one-time health care in general environment, or the barrier or protection of particles such as flower powder outside pathogenic microorganisms.

Relevant standards

(1) Gb19083-2010 technical requirements for medical protective masks

(2) Yy0469-2011 technical requirements for medical surgical masks

(3) Yy/t0969-2013 disposable medical mask