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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 - 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
  • 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
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 D5151 - 19 , ASTM D6124 - 06 (Reapproved) , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05 (Reapproved 2022) , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 21 , ASTM F2101 - 22 , ASTM F1819 - 19 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3

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