ASTM F2100-19

    Standard Specification for Performance of Materials Used in Medical Face Masks


      Format Pages Price  
    PDF 4 $54.00   ADD TO CART

    Active (view current version of standard)

    Other Historical Standards

    Work Item(s) - proposed revisions of this standard

    ASTM License Agreement

    More F23.40 Standards Related Products


    1. Scope

    1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care.

    1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.

    1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not apply to regulated respiratory protection, which may be necessary for some healthcare services.

    1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.5 The following precautionary caveat pertains only to the test methods portion, Section 9, of this specification: 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.

    1.6 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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    F1494 Terminology Relating to Protective Clothing

    F1862 Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

    F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

    F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

    Federal Standards

    16 CFR Part 1610 Standard for the Flammability of Clothing Textiles

    29 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule

    42 CFR Part 84 Approval of Respiratory Protective Devices

    ISO Standard

    ISO 2859-1 Sampling Plans for Inspection by Attributes


    ICS Code

    ICS Number Code 11.140 (Hospital equipment)

    UNSPSC Code

    UNSPSC Code 46182001(Masks or accessories)


    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F2100-19

    Citation Format

    ASTM F2100-19, Standard Specification for Performance of Materials Used in Medical Face Masks, ASTM International, West Conshohocken, PA, 2019, www.astm.org

    Back to Top