U.S. – ASTM International Publishes F3502 Safety Specifications for Barrier Face Coverings

Vol. 1226 | February 19, 2021

ASTM International (ASTM) has approved new standard F3502 Safety Specifications for Barrier Face Coverings (BCF). The first of its kind, this standard is intended to cover general consumer face coverings and explicitly excludes face masks (medical masks) for use in healthcare settings regulated by the U.S. Food & Drug Administration (FDA), as well as respirators intended to be used as personal protective equipment (PPE) in workplace environments requiring NIOSH approval. The barrier face coverings are intended to be used for source control by reducing the number of expelled droplets from the wearer’s nose and mouth, while offering protection by filtering particulate matter to reduce amount inhaled by the wearer.

Following are the key requirements established by the standard:

  • Performance
    • Sub-micron particulate filtration efficiency Level 1-(PFE) ≥ 20%; Level 2 (PFE) ≥ 50%;
    • Air flow (breathing) resistance – Level 1 Inhalation ≤ 15 mm H2O; Level 2 Inhalation ≤ 5 mm H2O
    • Note – Any combination of levels for the two tests may be reported
  • General construction
    • Designed to cover at least wearer’s face and mouth
    • Fit snugly to minimize leakage
    • Quantitative leakage assessment allowed either via design analysis or using ASTM F3407
    • Prohibition on including vents, valves, or other features that allow for airflow to bypass the filtration elements of barrier face coverings during exhalation
    • Free of sharp edges, sharp points or burrs
    • Retention system for keeping barrier face covering on user’s nose and mouth for expected period of use and activities
    • Sizing
  • Flammability
    • Material shall be Classified as Class 1 or Class 2 when tested per 16 CFR 1610
  • Conformity assessment
    • Model A requirements in Guide ASTM F3050
    • PFE and air flow (breathing) resistance evaluations must be performed by a laboratory that is ISO 17025 accredited and has the specific test within their accreditation scope
  • Labeling: below is some key information required on product, packaging or both
    • Manufacturer’s name and information
    • Performance of PFE and air flow (breathing) resistance either as Level 1 and Level 2 or continuous performance pictogram
    • Material
    • Traceability information

A reusable barrier face covering shall meet performance requirements for sub-micron particulate filtration efficiency and airflow resistance in addition to the leakage assessment design analysis requirements in its as-received state and after manufacturer-specified maximum number of use and laundering cycles.

Currently there are numerous barrier face coverings available in the marketplace. However, it is difficult for a consumer to distinguish performance of different products. This standard will serve as a useful tool for brands and retailers developing barrier face coverings in evaluating the performance of product and conveying useful performance information to the consumers through the use of labeling.

A copy of ASTM F3502 standard can be purchased from: https://www.astm.org/Standards/F3502.htm

ASTM is providing free access to F3502 and certain other personal protective equipment related standards at https://www.astm.org/COVID-19/

For more information, please contact Dr. Pratik Ichhaporia (pratik.ichhaporia@intertek.com, +1-847-212-8273) or Jason Allen (jason.allen@intertek.com, +1-607-758-6537).

 

 

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