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ASTM F2100

Standard Specification for Performance of Materials Used in Medical Face Masks

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ASTM F2100: Performance of Materials Used in Medical Face Masks

The ASTM F2100 test specification outlines the classification of performance for material used in medical face masks. This standard encompasses testing and performance requirements for materials used to construct medical face masks intended for healthcare services such as surgery and patient care.

This standard does not cover all design and performance aspects of medical face masks, nor does it assess their effectiveness in terms of barrier and breathability properties. Additionally, it is not applicable to respiratory protection, which may be required for certain healthcare services.

Medical face mask material performance is assessed based on Bacterial Filtration Efficiency, Differential Pressure, Sub-Micron Particulate Filtration Efficiency, Resistance to Penetration by synthetic blood, and Flammability. However, it’s important to note that the test standard does not address all aspects of medical face mask design and performance, including the effectiveness of mask designs related to the barrier, breathability properties, and respiratory protection, which may be necessary for certain healthcare services.

Medical face mask materials covered under this specification are designated as one or more of the following performance classes based on the barrier performance properties:

  • Level 1 Barrier
  • Level 2 Barrier
  • Level 3 Barrier

Level 1 Evaluated for their ability to capture sub-micron particles, resistance to penetration by synthetic blood at the Minimum velocity, bacterial filtration efficiency, and differential pressure. Generally used for low-risk situations and procedures, such as visiting a doctor’s office or on public transportation. Designed to protect against respiratory and large particle droplets. These masks are crafted with lightweight, breathable materials and have ear loops or ties to secure the mask in place.

Level 2 is evaluated for its ability to capture sub-micron particles and is assessed for resistance to penetration by synthetic blood at the Middle velocity, Bacterial filtration efficiency, and differential pressure. Typically used in moderate-risk situations, such as dental procedures or hospital visits. Made with more substantial and thicker materials than Level 1. It is intended to provide a higher level of protection than Level 1 and should block at least 98% of tiny (0.1 microns) particles.

Level 3 Evaluated for resistance to penetration by synthetic blood at the Maximum velocity, Submicron Particulate filtration, Bacterial filtration efficiency, and differential pressure.

Generally used in high-risk situations like surgery or exposure to any body fluids. These masks are constructed from the thickest and most substantial materials among ASTM face mask levels, designed to offer the highest degree of protection.

They also have excellent breath resistance and may be used in surgeries or procedures that produce a lot of aerosols. The highest level of protection is provided by Level 3 masks, which are required to have a bacterial filtration efficiency (BFE) of ≥ 98% and a differential pressure of ≤ 160 mm Hg. They are designed to block at least 98% of tiny (0.1 micron) particles and have a high filtration efficiency (up to 99%) for larger particles.

Test Methods for Performance of Materials Used in Medical Face Masks:

  1. Bacterial filtration efficiency (BFE): Measures the effectiveness of mask material in preventing the passage of aerosolized bacteria.
  2. Differential Pressure: Measures the airflow resistance and breathability. The Differential Pressure- is expressed in mm H2O/cm2.
  3. PFE (Particle Filtration Efficiency): 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. Fluid Resistance: 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. 16 CFR Flammability Test: 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).

      • This test method assesses medical face mask materials for their use in protective clothing, rather than as respirators.

      • If respiratory protection for the wearer is needed, a NIOSH-certified respirator, aka N19 mask, should be used.

      • This specification covers the minimum performance requirements for materials used to construct medical face masks.

      • Medical face mask performance classes are based on the materials’ barrier performance properties (fluid resistance, bacterial filtration efficiency, and sub-micron filtration efficiency).

Importance of ASTM F2100

  • ASTM standards are essential for the medical face mask industry because they guide the manufacture of face masks that protect people from infection.
  • The most critical ASTM standard for medical face masks is ASTM F2100, which provides performance requirements for three types of masks: Level 1, Level 2, and Level 3.
  • Masks must meet specific filtration and fluid resistance requirements to be classified as a medical face mask.
  • The ASTM F2100 standard is primarily designed for medical face masks; it can also be applied to other types of personal protective equipment (PPE), such as respirators.
  • A mask must undergo a series of tests to measure its ability to protect the wearer from exposure to various airborne contaminants.
  • The most important of these tests is the “filtration efficiency” test, which measures how well a mask can filter out small particles from the air.
  • A mask that passes this test with a 95% or higher filtration efficiency is considered a “medical grade” face mask.

Why choose Microbe Investigations (MIS)?

Need assistance with face mask testing for your products? Look no further! At Microbe Investigation Switzerland (MIS), our team of experts is committed to providing precise and accurate testing services that strictly adhere to international standards. With our fast turnaround time, we ensure that your face mask products meet all safety and quality requirements swiftly.

Our team of experts is equipped with the latest technologies and profound industry knowledge to provide you with comprehensive testing solutions.

To get a quote on ASTM F2100 or want to know more about our services, talk to our experts here.


ASTM F 2100 specification covers the classifications, performance requirements, and test methods for the construction materials used in medical face masks.

Surgical Face Masks and General-Use Masks can be tested with ASTM F2100.

ASTM F2100 test takes 8-12 weeks to complete.

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