ASTM F2101
Scope
1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream
bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.
1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration
efficiency that can be determined by this method is 99.9 %.
1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker
exposure and assess the appropriateness of the method for their specific applications.
1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as
respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular
medical face mask material do not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used
in the construction of the medical face mask and not its design, fit, or facial-sealing properties.
1.5 Units—The values stated in SI units or inch-pound units are to be regarded separately as standard. The values
stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance of the
standard.
1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the
medical face mask material.
1.7 This test method may also be used to measure the bacterial filtration efficiency (BFE) of other porous medical products such as surgical gowns,
surgical drapes, and sterile barrier systems.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this
standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on
Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Keywords
aerosol; bacterial filtration efficiency (BFE); medical face mask materials;
ICS Code
ICS Number Code 11.140 (Hospital equipment)
DOI: 10.1520/F2101-22