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BFE Test: Filtration Performance in Masks

Bacterial Filtration Efficiency Test on Medical Masks

BFE Test: Filtration Performance in Masks

What is BFE Testing?

Bacterial Filtration Efficiency (BFE) refers to the mask's capacity to retain aerosol particles containing bacteria of a given size. This test is applied to assess how effective the mask is in the following conditions:

  • The Mask's Ability to Protect the Wearer: Bacterial particles in the external environment are filtered out by the mask during the wearer's breathing.
  • Protection of the Environment: The filtering of bacteria-carrying particles that may enter the air during the user's exhalation.

How is BFE Testing Performed?

BFE testing is usually performed in accordance with ASTM F2101 or EN 14683 standards. The general procedure of the test is as follows:

  1. Bacterial Aerosol Generation:
    • An aerosol containing a certain size of bacteria (e.g. Staphylococcus aureus) is sprayed towards the mask.
    • The size of the bacterial particles is usually around 3 µm.
  2. Filtration Performance of the Mask:
    • A portion of the aerosol is passed through the mask and the filtering efficiency of the mask is measured.
    • The amount of bacteria passed or filtered by the mask is evaluated.
  3. Calculation of Results:
    • The filtering efficiency of the mask is calculated according to the formula below: BFE (%)=(1-Beginning Number of BacteriaNumber of Bacteria Passed)×100
  4. Test Conditions:
    • The test is usually performed at an air flow rate of 28.3 L/min.
    • The surface of the mask is fixed in accordance with standard procedures.

BFE, or bacterial filtration efficiency, is based on the determination of the filtration efficiency of Type I, Type II and Type IIR medical masks based on the ratio of the upstream bacterial difficulty of the masks to the downstream residual concentration.

Filtration efficiency should be as follows for mask types:

  • Type I: ≥ 95
  • Type II: ≥ 98
  • Type IIR: ≥ 98

BFE (Bacterial Filtration Efficiency) test is performed on materials that should provide protection against biological aerosols such as surgical gowns, caps and air filters within the scope of different standards other than medical masks.

BFE (Bacterial Filtration Efficiency) test is performed within the scope of ASTM F2100, EN 14683 standards. It is also one of the required analyzes in FDA 520(k) surgical mask applications.


Importance of BFE Test

  1. Public Health and Safety: The bacterial filtering ability of masks is critical to prevent the spread of infections.
  2. Legal and Regulatory Compliance: BFE testing proves compliance of surgical masks and other medical products with international standards.
  3. Performance and Quality Assurance: Provides a baseline assessment to verify the effectiveness and durability of the mask.
  4. Product Classification and Labeling: Accurate classification of masks allows users to make the appropriate choice for their needs.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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