On February 15, 2021, ASTM International, a voluntary standards-setting organization, approved a new national standard for barrier face coverings (BFCs) that establishes minimum design, performance, labeling and care requirements for disposable and reusable face masks. This standard is the first of its kind, providing consumers with long-awaited guidance for purchasing everyday, general use masks. This guidance is particularly important in light of the reusable face coverings that have flooded the market since the onset of the COVID-19 pandemic. Until now, consumers had no way of determining whether the face covering they bought was evaluated for efficacy in either source control or personal protection.
What Manufacturers Should Know
In order to meet the new standard, manufacturers must first test their coverings at accredited laboratories. Next, they must complete a conformance assessment certifying that their coverings comply with all ASTM design, performance, labeling and care requirements. Manufacturers who meet these design and performance requirements may include on their label that the product "meets ASTM F3502."
To obtain compliance with the standard, manufacturers must test their coverings based on three main performance criteria: protection/source control, comfort and reuse potential. Protection and source control of face coverings are measured by filtration efficiency, and comfortability is measured by airflow resistance. Filtration efficiency measures the amount of particulates that are blocked by the covering, during both inhalation and exhalation. Airflow resistance measures how easily a user can breathe while wearing the covering. Depending on the result, the BFC can fall into one of two classifications, with Level 2 offering greater performance and protection.
To meet the new standard, manufacturers must show that their BFCs block at least 20 percent of particulates from passing through the filtration materials of the product. This is classified as Level 1 efficiency. Any BFC that blocks 50 percent or more of these particulates is classified as Level 2 efficiency. Additionally, BFCs must only allow a maximum airflow resistance at 15 mm H2O (Level 1). Any BFC that allows for less than 5 mm H2O airflow is considered to perform at a higher level, enabling the user to breathe more easily. Manufacturers will be able to note the classification level on their product packaging.
Notably, ASTM explains that it is possible for a product to have high performance in one category, such as Level 2 filtration efficiency, but low performance in another, meaning airflow resistance that makes it harder to breathe. The classification system is simply meant to be a tool that helps the user understand the trade-offs between the two categories.
Leakage Assessment and Reuse Testing
In addition to filtration efficiency and airflow resistance testing, manufacturers must also conduct a leakage assessment to analyze how well the BFC prevents particles from entering or exiting the barriers/edges of the covering. If manufacturers market their product as reusable, they are also required to evaluate the impact that cleaning has on the filtration efficiency, airflow resistance and leakage assessment.
The standard also provides labeling requirements for manufacturers. At a minimum, the BFC label must include: (1) the manufacturer's name, identification, designation or logo; (2) the barrier face covering model or style; and (3) the statement "Meets ASTM." Additionally, the following warning must be printed on the smallest saleable unit/package and must be viewable in its entirety:
MEETS ASTM F3502, SPECIFICATION FOR BARRIER FACE COVERINGS. THIS PRODUCT IS PRIMARILY INTENDED AS A MEANS OF SOURCE CONTROL FOR MINIMIZING THE PROJECTION OF EXPELLED MATERIALS FROM THE WEARER'S NOSE AND MOUTH. WARNING: THIS BARRIER FACE COVERING IS NOT A MEDICAL FACE MASK AS DEFINED IN ASTM F2100, IS NOT INTENDED FOR USE IN MEDICAL PROCEDURES, AND IS NOT A RESPIRATOR.
Finally, the product's packaging must also include the materials of construction, size, expiration date and whether the product is indicated for single use or whether it can be reused.
A manufacturer must also provide user instructions, including information on sizing, storage and directions on how to take the covering on and off. If the covering is reusable, then there also must be inspection, use and care instructions included on the packaging.
Manufacturers should take full advantage of this new guidance as it implements a universal standard for the evaluation of barrier face coverings utilized by a majority of Americans every day. With this standard in place, consumers can be confident that the coverings they are purchasing have complied with national standards for these important products.
Additionally, application of this standard to a products liability litigation context could have a substantial impact on manufacturers and potential claimants. Manufacturers might point to compliance with these new standards as relevant to evaluation of a standard of care or as potential evidence of reasonable conduct in products liability claims.
The full standard is available on ASTM's website and is free to all users.
For More Information
If you have any questions about this Alert, please contact Sharon L. Caffrey, Dana J. Ash, Katelyn A. Romeo, any of the attorneys in our Products Liability and Toxic Torts Group, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.
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