What Are BFE and PFE Tests for Medical Masks?|Standards, Methods & Equipment Differences Explained

What Are BFE and PFE Tests for Medical Masks?|Standards, Methods & Equipment Differences Explained
What Are BFE and PFE? Key Mask Filtration Metrics
BFE (Bacterial Filtration Efficiency) measures a mask’s ability to filter out bacteria. The test typically uses -Staphylococcus aureus-, around 3.0 μm in size.

PFE (Particle Filtration Efficiency) assesses how well the mask captures much smaller particles, usually 0.1 - 0.3 μm similar in size to viruses. It uses synthetic test particles like polystyrene latex (PSL).


These two figures are essential for evaluating mask performance in infection control, especially in medical and high-risk environments.


International Standards for BFE and PFE
Different countries apply various mask performance standards:
・ ASTM F2100 (USA):
- Level 1: BFE & PFE ≥ 95%
- Level 2 & 3: BFE & PFE ≥ 98% (recommended for surgeries and infectious disease protection)
・ EN 14683 (Europe):
- Type I: BFE ≥ 95%
- Type II / IIR: BFE ≥ 98% (Type IIR also includes fluid resistance)
・ JIS T 9001 (Japan):
- Aligns with ASTM and EN standards
- Ensures masks used in healthcare settings meet safety benchmarks
Complying with these standards is critical for regulatory approval and user trust.

How BFE Testing Is Conducted
The BFE test introduces bacterial aerosols to one side of the mask. A nebulizer produces mist containing -Staphylococcus aureus-, which flows through the mask at 28.3 L/min.
Downstream bacteria that pass through are captured using a cascade impactor (Andersen method). These are then cultured, and colony-forming units (CFUs) are counted.
BFE = (Upstream CFUs – Downstream CFUs) / Upstream CFUs × 100%
This measures how effectively the mask blocks bacteria-sized particles.

How PFE Testing Is Conducted
The PFE test uses non-living synthetic particles (e.g., PSL) with controlled diameters of 0.1 μm or 0.3 μm. These particles are passed through the mask using a particle generator.
A laser particle counter measures concentration before and after the mask. The resulting PFE shows how well the mask filters virus-sized particles.
PFE = (Upstream particle count – Downstream count) / Upstream × 100%
This is especially relevant for evaluating masks used during airborne disease outbreaks.

Best Practices for Reliable Test Results
To ensure test accuracy and reproducibility, follow these key protocols:
・ Conditioning: Store masks at 21±5°C and 85±5% RH for at least 4 hours before testing
・ Seal integrity: Ensure no leaks or gaps during mask mounting
・ Calibration: Flow rate and particle counters must be precisely calibrated
・ Particle quality: Use consistent-size, stable-concentration particles
Proper setup reduces error and ensures compliance with global mask standards.

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❓ FAQ
Q: How are BFE and PFE different?
A: BFE uses ~3 µm bacteria, while PFE uses 0.1–0.3 µm synthetic particles to assess filtration of finer aerosols.

Q: Why must masks be conditioned before testing?
A: To stabilize the material and ensure measurement accuracy under standard conditions.

Q: What is an Andersen impactor?
A: A multi-stage device that separates and collects aerosolized bacteria for BFE testing.

📚 Glossary
BFE: Bacterial Filtration Efficiency
PFE: Particle Filtration Efficiency
PSL: Synthetic test particles used in PFE
CFU: Colony Forming Units
Andersen Impactor: Multi-stage microbial aerosol collector

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