ASTM Publishes Its First Standard Specification for Face Masks

Arent Fox

Arent Fox

It covers both single-use (disposable) and reusable products for use by workers and by the general public.

ASTM International, formerly the American Society for Testing and Materials, is a premier international standards organization based in Pennsylvania that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Over 12,000 ASTM standards operate globally. Although they are designed to be voluntary consensus standards, they may become mandatory when referenced by the government. Thus, in the United States, ASTM standards have been adopted, by incorporation or by reference, into many federal, state, and municipal government regulations.

ASTM has just approved and published a new 16-page standard for single-use (disposable) and reusable face masks, F3502-21 “Standard Specification for Barrier Face Coverings,” developed by its Committee F23 on Personal Protective Clothing and Equipment.  It is the first ASTM standard to address this type of product, one that is neither a medical face mask (already covered by ASTM Standard Specification F2100-19) nor a respirator designed to provide inhalation protection to the wearer (as covered by NIOSH regulations at 42 CFR Part 84).  Its focus is on performance in three areas: source control and protection, comfort (especially if coverings are to be worn for long periods of time), and potential for reuse.

The new standard applies to coverings intended for the general public and for workers; it includes specific requirements for barrier face coverings such as design and general construction criteria, particle filtration efficiency levels, sizing and fit testing criteria, labeling instructions, and guidance on cleaning and useful life.

The new standard is intended to ensure that products meeting its requirements provide:

  • a means of source control for wearers by limiting the extent to which droplets and aerosols from the wearer’s nose and mouth are expelled into the surrounding air; and
  • a potential limit to the inhalation by the wearer of the expelled droplets and aerosols of others around them by particulate filtration.

The standard sets minimum criteria for design, performance and testing, labeling, and user instructions.

  • Design criteria include minimum coverage areas over the wearer’s nose and mouth, a means of keeping the covering in place over the nose and mouth, the prohibition of open vents or valves, the assessment of leakage of exhaled air, and a representation of product sizing.
  • Performance and testing criteria define minimum performance properties for filtration efficiency (including sub-micron particles filtration efficiency) and airflow (breathing) resistance, as well as the impact of repeated cleaning or laundering on performance of reusable coverings.
  • Labeling requirements specify the minimum amount of information that should be provided on labels on the covering, its immediate packaging, and point-of-sale packaging (if any).
  • User instruction requirements cover selection and sizing, proper positioning and adjustment, replacement and disposal, and care and cleaning (where applicable).

The standard provides a system for reporting key performance properties that meet one of two different levels of performance above the minimum requirements for sub-micron particulate filtration efficiency and for airflow resistance, to allow end users to differentiate products.

The standard does not address the use of antimicrobial materials or finishes.  It makes no representation that coverings meeting the requirements of the standard qualify as approved respiratory protection devices, have FDA clearance for use in a healthcare setting, or may be used on children under 2 years of age, or by anyone who has trouble breathing, is unconscious, incapacitated, or otherwise unable to remove a face covering without assistance.  Finally, it does not attempt to address any and all safety concerns associated with its use.

ASTM has made this new F3502 standard freely accessible via its COVID-19 web-page at ASTM Standards & COVID-19.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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