What are the Medical Face Mask breathability test standards?

 

1. Pressure difference method to test PFE (Particle Filtration Efficiency):

This test method is mainly used to evaluate the filtration efficiency of masks against particulate matter. During the test, a pressure difference is formed between the upstream and downstream of the mask, and the particles are suspended in the test airflow. After passing through the mask, the capture efficiency of the particles is measured, usually expressed as a percentage.

2. Pressure difference method to test Delta P:

This test method is used to evaluate the breathability of masks. By creating a pressure difference upstream and downstream of the mask, the pressure difference between the upstream and downstream of the mask is measured in millimeters of water column (mmH2O). The smaller the pressure difference, the smaller the breathing resistance of the mask and the better the breathability.

 

3. Microbial Filtration Efficiency (BFE):

This test method is used to evaluate the filtration efficiency of masks against bacteria. During the test, spray a bacterial solution with a determined stable concentration and size on the mask, and measure the number and density of bacteria penetrating the mask, expressed as a percentage.

4. Hygroscopicity test:

This test method is used to evaluate the mask's ability to absorb moisture. During the test, a certain amount of water droplets are placed on the inside of the mask and the diffusion of the water droplets within a certain period of time is observed to evaluate the hygroscopic performance of the mask.

 

These test standards are usually formulated by relevant medical device and personal protective equipment standard organizations or regulatory agencies, such as the US FDA (US Food and Drug Administration), the European Committee for Standardization (CEN), and the China National Medical Products Administration. Different regions and countries may have different Medical Face Mask breathability test standards, and manufacturers need to follow the applicable standard requirements for testing and certification when producing masks.