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NIOSH issues production and design criteria for facemask manufacturers

Nurse with face mask
Photo: FG Trade/iStockphoto

Washington — NIOSH has issued criteria and interim guidance to help manufacturers produce and design masks intended to protect workers from COVID-19.

Masks “must conform to all of the design requirements and meet the performance criteria” in the ASTM F3502-21 Barrier Face Covering Standard, meet additional NIOSH performance criteria, and undergo testing. The NIOSH criteria includes leakage ratio requirements.

Additionally, NIOSH says mask manufacturers should provide information about proper use, conform to minimum labeling criteria and have a system to maintain consistent mask quality.


Under the ASTM design requirements, masks must:

  • Cover the wearer’s nose and mouth and fit snugly against the sides of the face and nose without gaps, as determined by the design analysis.
  • Have a way to stay in place over the nose and mouth for the expected period of use and range of activities.
  • Have nonirritating and nontoxic materials where the mask contacts the skin.
  • Be either disposable (single use) or reusable (multiple use).
  • Be able to be worn by individuals with a range of fit characteristics (excluding children younger than 2), or designed with multiple sizes to allow fit for a wide variety of people.

NIOSH warns that masks can’t be used as a replacement for respiratory protection or respirators when those are required.

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