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ASTM F2100 Testing for Medical Face Masks (Levels 1, 2 & 3 Performance Standard)
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Summary
ASTM F 2100 is used to evaluate the performance of materials used in medical face masks. It classifies the medical face masks into level 1,2,3 based on performance factors such as Bacterial filtration efficacy (BFE), Particulate filtration efficacy (PFE), Differential pressure for breathability, Resistance to synthetic blood penetration and Flammability.
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Quick understanding of the test
ASTM F2100 - Performance of materials used in medical face masks
ASTM F2100 is used to evaluate performance of materials used in making medical face masks.. It evaluates bacterial filtration, breathability, particulate filtration, synthetic blood resistance, and flammability.
Application
Applicable to medical face mask materials intended for use in healthcare settings.
Mandatory test strains
- Staphylococcus aureus for Bacterial Filtration Efficiency test.
- Bacterial Filtration Efficiency (BFE): Measures bacteria filtration using aerosolized S. aureus.
- Differential Pressure (Delta P): Assesses breathability by measuring airflow resistance.
- Particulate Filtration Efficiency (PFE): Tests filtration of submicron particles.
- Fluid Resistance: Evaluates synthetic blood penetration under varying pressures.
- Flammability: Tests burn time under controlled flame exposure.
- Ensures comprehensive assessment of medical face masks by providing various testing methods.
- Establishes consistent performance benchmarks for manufacturers, ensuring reliable and compliant face masks for patient care and surgical use.
Turnaround Time
Passing criteria
Masks must meet specific performance benchmarks based on their classification (Levels 1, 2, or 3) in parameters such as bacterial filtration efficiency (≥ 95% or 98%), resistance to synthetic blood, and breathability.
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What is ASTM F2100?
The ASTM F2100 test specification defines the classification and performance of materials used in medical face masks. These masks are intended for use in healthcare settings, such as surgeries and patient care, to protect both the wearer and others from potential exposure to harmful particles and fluids.
ASTM F2100 Standard Specification for Medical Face Masks
As stated in this standard, the performance of medical face mask materials is evaluated based on the following factors –
- Bacterial Filtration Efficiency (BFE)
- Differential Pressure
- Sub-Micron Particulate Filtration Efficiency
- Resistance to Penetration by Synthetic Blood
- Flammability
Based on test results, each mask is classified into Level 1, 2, or 3
ASTM F2100 Mask performance criteria
1. Bacterial filtration efficiency (BFE) – ASTM F 2101
BFE refers to the ability of the mask material to filter out aerosolized bacteria.
The test involves passing an aerosolized culture of S. aureus through the mask material with controlled airflow. The bacteria collected on the agar plates are then incubated and enumerated.
Higher percentages indicate better bacterial filtration.
2.Differential pressure (Delta P) – Breathability
Measures the airflow resistance and breathability. The Differential Pressure- is expressed in mm H2O/cm2.
3.Particulate filtration efficiency (PFE) – ASTM F 2299
PFE measures how well a hospital mask filters submicron particles. It is used to predict that viruses will also be filtered similarly. Higher percentages indicate better mask filtration. ASTM F2100 recommends testing with particle sizes ranging from 0.1 to 5 microns.
4.Synthetic blood penetration – ASTM F 1862
Fluid resistance refers to the ability of the surgical mask to reduce the transfer of fluid from outer layers to inner layers as a result of splashes or sprays. ASTM advises testing the fluid resistance of materials using synthetic blood under pressures of 80, 120, and 160 mm Hg. This allows the testing to determine if the mask can minimize fluid transfer from the outer and inner layers due to a splash or spray.
5.Flammability – 16 CFR part 1610
The 16 CFR Part 1610 standard, generally used in flammability tests, explains the requirements for flammability of textile products and offers test methods. This standard was developed by the National Institute of Occupational Health and Safety (NIOSH).
The test involves placing a strip of the mask material in a flammability testing apparatus. The material is exposed to a controlled flame for a specified period. The burn time for the material is recorded.
ASTM F 2100 Levels explained
ASTM F 2100 Level 1 requirements
Level 1 masks are tested for their ability to filter sub-micron particles, resist synthetic blood penetration at minimum velocity, and maintain bacterial filtration efficiency. These masks are normally used in low-risk environments such as doctor’s offices or even public transportation. The Level 1 mask is light and made from breathable materials.
Purpose : It provides basic protection against large respiratory droplets and particles. They are typically secured with ear loops or ties.
ASTM F 2100 Level 2 requirements
Level 2 masks offer a moderate level of protection. Testing includes filtration of sub-micron particles and resistance to synthetic blood penetration at moderate velocity. These masks are manufactured using thicker materials than Level 1 masks and can effectively block at least 98% of particles as small as 0.1 microns.
Purpose : They are typically used in moderate-risk situations, such as in dental procedures or while visiting hospitals.
ASTM F 2100 Level 3 requirements
The Level 3 masks offer the most protection. These masks are tested for the penetration of synthetic blood at the maximum velocities, particulate filtration efficacy, and bacterial filtration efficacy.ASTM Level 3 masks are manufactured from the thickest material and hence are capable of blocking 98% of the particles which are usually as small as 0.1 microns. Their bacterial filtration efficacy has to be a minimum of 98% along with less than 160 mm Hg differential pressure.
Purpose : These masks are used in situations with high risks of exposure, for example, during surgeries or procedures that involve bodily fluid or aerosol exposure.
Characteristic | Level 1 (Barrier) | Level 2 (Barrier) | Level 3 (Barrier) |
Bacterial filtration efficiency (%) | ≥ 95 | ≥ 98 | ≥ 98 |
Differential pressure (mm H₂O/cm²) | < 4.0 | < 5.0 | < 5.0 |
Sub-micron particulate filtration efficiency at 0.1 micron (%) | ≥ 95 | ≥ 98 | ≥ 98 |
Resistance to penetration by synthetic blood (minimum pressure in mm Hg for pass result) | 80 | 120 | 160 |
Flame spread | Class 1 | Class 1 | Class 1 |
ASTM F2100 Delta P units and Breathability limits
Breathability is measured as differential pressure, which quantifies how much pressure the mask media resists as air flows through it. Lower values of ΔP indicate easy breathing through the mask. ΔP is reported in mm H₂O/cm². Differential pressure limits are different for different levels of masks.
Level 1 – <5.0mmH2O/cm²
Level 2 & 3 – <6.0mmH2O/cm²
ASTM F 2100 : BFE vs PFE
Parameter | BFE (Bacterial Filtration Efficiency) | PFE (Particulate Filtration Efficiency) |
Full Form | Bacterial Filtration Efficiency | Particulate Filtration Efficiency |
Test Method | ASTM F2101 | ASTM F2299 |
What It Measures | Ability of mask material to filter aerosolized bacteria | Ability of mask material to filter submicron particles |
Challenge Type | Biological aerosol (bacteria) | Non-biological particles (e.g., latex or polystyrene spheres) |
Result expression | Percentage of bacteria filtered | Percentage of particles filtered |
Minimum requirement – level 1 | ≥ 95% | ≥ 95% |
Minimum requirement – level 2 | ≥ 98% | ≥ 98% |
Minimum requirement – level 3 | ≥ 98% | ≥ 98% |
Clinical Relevance | Reflects protection against bacterial droplets | Reflects filtration of smaller airborne particles |
ASTM F2100 vs ASTM F2101 for medical face mask
Parameter | ASTM F2100 | ASTM F2101 |
Purpose | Covers BFE, PFE, Delta P, synthetic blood resistance, and flammability | Measure Bacterial Filtration Efficiency (BFE) of mask materials. |
Test conditions | Different tests use different environments to check various properties. | Uses Staphylococcus aureus as the challenge bacteria for filtration testing. |
Result | Categorizes masks into Level 1, 2, 3 based on test results. | Reports a BFE percentage value (% bacteria blocked) |
Key Difference | A full performance standard for classifying masks. | A single test method used within F2100 (and other standards) to measure BFE. |
Industries that require ASTM F2100 testing
- Surgical mask manufacturers
- Medical device manufacturers
- Healthcare suppliers
- Hospital procurement teams
- Importers supplying U.S. healthcare markets
Importance of ASTM F2100
The ASTM F2100 standard is vital for both manufacturers and healthcare professionals. For manufacturers, it provides a framework for assessing the materials used for product development thus aiding in developing medical face masks that meet set standards of performance within the industry. During the development of the product, materials are tested for bacterial filtration, breathability, and fluid resistance to enable manufacturing companies to create products that are in compliance with regulatory demands.
Masks tested against this standard provide health professionals with an assurance of the level of protection that they can expect from these masks. In return, this allows them to choose appropriate masks according to the risk level in specific medical environments and ensure both their safety and the safety of their patients.
Why choose our lab for ASTM F2100 testing
Ensure the safety and effectiveness of your medical face masks with ASTM F2100 testing services. At Microbe Investigations Switzerland, we provide expert testing services to help you meet regulatory standards and deliver high-quality products.
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Frequently Asked Questions
DR. Martinoz Scholtz
The ASTM F2100 is a US test standard that evaluates the performance of medical face masks by assessing parameters such as bacterial filtration efficiency, differential pressure-breathability, sub-micron particulate filtration efficiency, synthetic blood penetration resistance, and flammability.
Delta P stands for differential pressure which measures the breathability of the mask which is expressed in mm H₂O/cm². Lower delta P values indicate easier breathing.
The main difference between ASTM F2100 level 2 and level 3 is fluid resistance threshold. Level 3 has a higher fluid resistance threshold (160 mm Hg) while Level 2 has 120 mm Hg.
ASTM F 2100 is not a mandated test method but is widely used for healthcare/surgical mask performance evaluation and recognized by regulatory bodies like EPA and FDA in the US.
No. ASTM F2100 does not require viral filtration efficiency (VFE) testing.
No, ASTM F2100 masks are medical/surgical masks rated by material performance and fluid resistance, while N95 respirators are NIOSH-certified respiratory protection devices evaluated for tight seal fit and ≥ 95% filtration of 0.3 µm particles.
ASTM F2100 is applicable to medical face mask materials intended for use in healthcare settings.
ASTM F2100 test takes 8-12 weeks to complete.
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