Regulatory News

ASTM International Publishes New Standard for Barrier Face Coverings

Mar. 25 2021

In February 2021, ASTM International published a new voluntary standard for Barrier Face Coverings. The standard, designated as ASTM F3502-21, provides minimum performance criteria and labeling requirements for Non-medical Protective Barrier Face Coverings. 
The Covid -19 pandemic coupled with the shortage of medical grade masks has resulted in the market growth for non-medical face coverings as a source control device to limit the spread of the disease.  Being a non-medical mask, the minimum expected performance requirements are not regulated directly by law.  This new ASTM F3502 standard specifies base line performance requirements for such masks worn as source control devices. 

This standard suggests minimum performance criteria for source control devices, based on the size of the particles allowed to penetrate the face covering, and also the level of leakage possible.  Breathing Resistance is another factor addressed in this safety standard. Two levels are defined for Sub Micron Particulate Filtration Efficiency, and Air Flow Resistance, to define the level of performance expected for the product. In addition, the new standard suggests testing to these parameters before and after laundering for re-useable product. Sizing information is also suggested based on facial dimensions as a baseline for fit. 

In addition to the existing recommended labeling that has been prescribed by the regulatory bodies, this document expands on the information to be provided to the consumer at the point of sale and for packaging.  The suggested labeling must state that the products are not medical devices and should not be used as a substitute for respirators used in medical settings.  

Other Performance Requirements
Other test requirements beyond the above mentioned performance include:
• 16 CFR 1610 
• Care labeling verification
• Mandatory labeling review
• Additional testing based on the product design or construction 

Bureau Veritas is pleased to inform you that testing is available in our Shanghai Laboratory. If interested in our testing services or have any technical inquires, pls. contact: 
Jensen Tian or Panny Pan 

Additional Information: To purchase a copy of the ASTM F3502-21 

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