COVID-19, Personal Protective Equipment

Nonregulatory Face Mask Standard Approved by ASTM

On February 17, ASTM International (formerly the American Society for Testing and Materials) announced approval of a nonregulatory standard for barrier face coverings in response to the COVID-19 pandemic. The standard establishes minimum care, design, labeling, and performance requirements for reusable barrier face coverings.

COVID-19 face mask, face coverings

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The standard was developed by ASTM’s F23 committee on personal protective clothing and equipment. Masks that conform to the new F3502 standard are not intended for use as medical procedure masks for source control or respirators for worker protection.

“Members of the committee worked together to reach a consensus and address the gap that exists for barrier face coverings that are neither a respirator nor a surgical mask,” ASTM International President Kathie Morgan said in statement.

“The standard helps to benchmark products and will inform consumers when selecting face coverings for their intended use.”

Some public health guidelines recommend the use of face coverings along with cleaning and sanitizing, hand hygiene, and social distancing to curtail COVID-19 infections. Face coverings also are recommended in the Occupational Safety and Health Administration’s (OSHA) “Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace.” Some state standards for workplace COVID-19 exposures require employers to provide face coverings for employees. ASTM’s F3502 standard may offer some guidance in selecting reusable face masks.

There is no federal COVID-19 or infectious disease standard, but on January 21, President Joe Biden gave OSHA until March 15 to consider establishing an emergency temporary standard (ETS) for COVID-19.

The ASTM face coverings standard includes two filtration performance levels: greater than or equal to 20% and greater than or equal to 50%. N95 filtering facepiece respirators are capable of 95% filtration.

Mask manufacturers seeking approval to include an F3502 label on their products would have to supply a certified testing laboratory with 10 specimens. Testing under the standard uses a modified version of the National Institute for Occupational Safety and Health’s (NIOSH) sub-micron particulate filtration efficiency testing method (42 CFR 82 Subpart K).

Certified products would carry a label statement that the products meet the ASTM F3502 specification for barrier face coverings. However, the label must state the products are not a medical mask or a respirator.

ASTM International also released a white paper, “Collaboration to Advance Personal Protective Equipment (PPE) Safety, Quality, and Innovation,” examining the current landscape of standards development for PPE. The COVID-19 pandemic led to challenges for standards-setting organizations and in PPE product quality. Challenges in PPE quality have included the lack of standards and certification, new environments and uses for PPE, and the reuse of single-use PPE. Challenges for standards-setting organizations have included lack of data on alternative manufacturing methods and new products offered, coordination of stakeholders, the time frame for developing standards, and standards dissemination, as well as conformity assessment.

ASTM identified three immediate next steps to address the new PPE challenges:

  1. Engaging potential stakeholders to gauge interest and gather input;
  2. Establishing an ad hoc leadership committee; and
  3. Spreading awareness through various communications materials.

ASTM acknowledged that future global health crises may be inevitable and a need to learn from the COVID-19 global pandemic and use takeaways from the experience to plan more effectively for the future crises.