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USA - The ASTM International Published the Standard Specification for Barrier Face Coverings (ASTM F3502-21)

FEBRUARY 2021 - SOFTLINES

Recently, the ASTM International published the Standard Specification ASTM F3502-21 for barrier face coverings and available for public access at no-cost.1

This Standard is applicable for single use and reusable barrier face coverings that are worn for the purpose of providing source control and to potentially reduce inhaled particulates. However, this Standard does not apply to the medical face mask as defined in the Standard ASTM F2100 and respirator as regulated under 42 CFR Part 84.

This Standard provides specification of various requirements such as:

  • Design: Some of the design characteristics for the barrier face covering as specified in the Standard are:

    • The barrier face covering must cover at least the wearer’s nose and mouth and fit snugly.
    • The materials that remain in contact of wearer’s skin shall be non-irritating and nontoxic.
    • Product shall not have any sharp edges, sharp points, or burrs.
    • Product shall be made of durable material that will not be damaged by ordinary handling, donning and doffing or after stated care treatment.
    • Face coverings are considered as wearing apparel, therefore it must comply with the Federal Flammability Standard 16 CFR 1610.
    • The design, shape or feature shall be constructed in such a way that it minimizes the air flow around the perimeter of the product.
  • Performance: The Standard specifies the minimum performance criteria for sub-micron particle filtration efficiency and airflow resistance (breathability) tests.
  • Classification: Based on the performance level in sub-micron particle filtration efficiency and airflow resistance test, each performance property is classified in following two levels:

    • Level 1 (Lower Performance): where the product meets the minimum performance requirements.
    • Level 2 (Higher Performance): where the product has superior performance as specified in the standard. 
  • Labelling: This Standard specifies labelling requirements to indicate various information on the product and packaging. The Standard provides specific statements to indicate that the products are compliant according to this standard.

 

Statement on the product label:

“MEETS ASTM F3502”

Statement on the package:

“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.”

Where the barrier face coverings are declared to be compliant with this Standard Specification, manufacturer must comply with Conformity Aassessment Requirements in accordance to the guide ASTM F3050 and the testing for sub-micron particulate filtration efficiency and airflow resistance shall be performed by an ISO/IEC 17025 accredited laboratory.

 

[1]  ASTM Standards, ASTM F3502-21

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