Model Standards For Medical Surgical Masks

Published:

2023-08-23


Medical surgical masks need to comply with my country's pharmaceutical industry standard YY 0469-2011 "Technical Requirements for Medical Surgical Masks", the main technical indicators are as follows:

1. Filtration efficiency:

Under the condition of air flow (30±2) L/min, the filtration efficiency of sodium chloride aerosol with aerodynamic median diameter (0.24±0.06) μm is not less than 30%.

2. Bacteria filtration efficiency:

Under the specified conditions, the filtration efficiency of Staphylococcus aureus aerosol with an average particle diameter of (3±0.3) μm is not less than 95%.

3. Respiratory resistance:

Under the condition of filtration efficiency and flow rate, the inhalation resistance does not exceed 49Pa and the exhalation resistance does not exceed 29.4Pa.

4. Synthetic blood penetration:

After 2ml of synthetic blood is sprayed on the outside of the mask at a pressure of 16.0kPa (120mmHg), there should be no penetration on the inside of the mask.

Material of medical surgical mask:

Medical surgical masks use polypropylene as the main raw material, and the fiber diameter can reach 0.5-10 microns. These ultra-fine fibers with unique capillary structure increase the number and surface area of fibers per unit area, so that the meltblown cloth has good filterability, Shielding, thermal insulation and oil absorption.

The material of the mask is made of non-flammable materials, and the mask burns for less than 5s after leaving the flame; the residual ethylene oxide of the mask sterilized by ethylene oxide should be less than 10μg/g; the primary skin irritation index of the mask material should be ≤0.4 , There should be no sensitization.