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ASTM F2101 - 23
ASTM International (ASTM)
Title

"Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus"

Description

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.

Standard Type(s)
Test Method

A definitive procedure that produces a test result: Examples of test methods include, but are not limited to: identification, measurement, and evaluation of one or more qualities, characteristics, or properties. A precision and bias statement shall be reported at the end of a test method.

Personal Protective Equipment
Eye and Face Protection

All equipment and/or accessories (whether or not detachable) designed and manufactured specifically to protect the eyes and/or the entire face (not including the top of the head). Exposure to the eye or face hazards from flying particles, molten metal, liquid chemicals, acids, or caustic liquids, chemical gasses, or vapors, potentially infected material or potentially harmful light radiation.

  • Face masks
Hazards
Biological
  • Biological
SOC Codes
29-0000 Healthcare Practitioners and Technical Occupations
  • 29-1000 Health Diagnosing and Treating Practitioners
    • 29-1060 Physicians and Surgeons
    • 29-1141 Registered Nurses
Standard References
Referenced Standard

ASTM F1414 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF141419(2023)) - Standard test method for measurement of cut resistance to chain saw in lower body (legs) protective clothing

Conformity Assessment Notes

This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted.  Please see the full standard for complete details.

Comments

Additional References:

ASTM Standards

  • E171 Practice for Conditioning and Testing Flexible Barrier Packaging
  • E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
  • E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
  • F1494 Terminology Relating to Protective Clothing

ANSI/ASQC Standard

  • ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes

ISO Standard

  • ISO 2859-1 Sampling Plans for Inspection by Attributes

Military Standard

  • MIL-STD 36954C (1973) Military Specification: Mask, Surgical, Disposable
Testing Laboratories
Intertek - Cortland, NY, 13045
Contact

Phone Number: (607) 753-6711
Email: jason.allen@intertek.com

Accreditations

ISO 17025

Scope of Accreditation

ANSI/ISEA Z87.1-2020(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/ISEAZ8712020) , ASTM F2412 - 18a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF241218a) , ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ASTM F1446 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF144620) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1359 / F1359M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1359/F1359M22) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F1790 / F1790M - 15 (Reapproved 2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1790/F1790M15(Reapproved2021)) , ASTM F2588 - 12(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF258812(2020)) , ASTM F739 - 20(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF73920) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ASTM F1862 / F1862M - 17(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1862/F1862M17) , ASTM F2100 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210023) , ASTM F2101 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210123) , ASTM F2299 / F2299M - 24(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF2299/F2299M24) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

Nelson Laboratories, Inc. - Salt Lake City, UT, 84123
Notes

FDA Registered and ANSI-ASQ National Accreditation Board/ACLASS
Contact

Phone Number: (801) 290-7500
Email: sdrosner@nelsonlabs.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D120 - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD12022) , ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) , ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) , ASTM D5151 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD515119(2023)) , ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) , ASTM D5712 - 15(2020)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD571215(2020)) , ASTM D6124 - 06(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD612406(2022)) , ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) , ASTM D6978 - 05(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD697805(2023)) , ASTM D7246 - 06(2021)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD724606(2021)) , ANSI/AAMI PB70:2022(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70%3a2022) , ASTM F1342 / F1342M - 05(2022)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1342/F1342M05(2022)) , ASTM F1670 / F1670M - 17a(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1670/F1670M17a) , ASTM F1671 / F1671M - 22(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1671/F1671M22) , ASTM F903 - 18(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF90318) , ASTM F1862 / F1862M - 17(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF1862/F1862M17) , ASTM F2100 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210023) , ASTM F2101 - 23(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF210123) , ASTM F1819 - 19(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMF181919) , ANSI/AAMI PB70 - Class 4(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class4) , ANSI/AAMI PB70 - Class 3(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3)

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