Medical face masks include medical surgical face masks, medical protective masks and disposable medical masks. Medical face masks can not only prevent viruses and germs, but also prevent dust. They are basic medical protective products. Medical masks approved for marketing as medical devices include medical protective face masks, medical surgical face masks and ordinary medical face masks. Ordinary degreased gauze masks are not managed as medical devices. As a medical face mask approved as medical devices, its performance is very different from that of ordinary anti-dust masks. The important technical indicators and application scope of its mask approval standards are as follows:
The protective medical face mask is applicable to the protection of medical personnel and relevant staff against airborne respiratory infectious diseases, with high protection level.
(1) Filtration efficiency: under the condition of air flow L/min, the filtration efficiency of sodium chloride aerosol, with the median diameter of Aerodynamics(0.24 ± 0.06) μM, shall not be less than 95%.
(2) Suction resistance: under the above air flow conditions, the suction resistance shall not exceed 343.2pa.
The medical surgical face mask is applicable to the basic protection of medical personnel or related personnel, as well as the protection against the transmission of blood, body fluids and splashes during invasive operation.
(1) Filtration efficiency: under the condition of air flow L/min, the filtration efficiency of sodium chloride aerosol, with the median diameter of Aerodynamics μM, shall not be less than 30%.
(2) Bacterial filtration efficiency: under the specified conditions, the filtration efficiency of Staphylococcus aureus aerosol, with the average particle diameterμM, shall not be less than 95%.
(3) Respiratory resistance: under the condition of filtration efficiency flow, the inspiratory resistance shall not exceed 49pa and the expiratory resistance shall not exceed 29.4pa.
The protective effect of ordinary medical face masks on pathogenic microorganisms is not accurate. They can be used for one-time health care in ordinary environment, or for blocking or prevention of particles other than pathogenic microorganisms, such as flower powder.
(1) The total number of initial contaminating bacteria of non-sterilized face masks shall not exceed 100 cfu/g, and no pathogenic bacteria shall be detected.
(2) The sterilized face medical mask shall be sterile and sterilized with ethylene oxide. When leaving the factory, its residue shall not exceed 10%μg/g.
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