Standard for Medical Face Masks, ASTM F2100-19

Woman wearing a medical face mask designed to ASTM F2100-19

Some 16 million people work in the healthcare sector, doing the work that keeps the rest of us alive. Personal protective equipment (PPE), such as medical face masks, are critical in protecting healthcare personnel while they provide services like surgery and patient care. Manufacturers that construct medical face masks, to produce a safe and reliable product, depend upon the testing and requirements for materials specified in ASTM F2100-19: Standard Specification For Performance Of Materials Used In Medical Face Masks.

This specification ultimately provides for the classification of medical face mask material performance. Medical face mask materials are designated as one or more of the following performance classes: Level 1 barrier, Level 2 barrier, and Level 3 barrier.

The barrier performance classes of medical face mask materials are based on bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. Users should refer to the ASTM F2100-19 document for testing procedures and other specific requirements.

Application of ASTM F2100-19

Covering the minimum performance requirements for materials, ASTM F2100-19 is intended for use by those constructing medical face masks.

This standard does not apply to regulated respiratory protection, nor does it cover medical face masks for all possible use situations. For example, as stated in the ASTM F2100-19 document, “the Centers for Disease Control and Prevention (CDC) specifically requires NIOSH respirators that are at least 95% efficient for tuberculosis exposure control.”

Referenced Documents in the Standard for Medical Face Masks

Since ASTM F2100-19 addresses such an integral topic in assuring safety of healthcare professionals, those who make use of it might typically need to be aware of similar specifications including the following documents referenced in ASTM F2100-19:

Many of these standards and ASTM F2100-19: Standard Specification For Performance Of Materials Used In Medical Face Masks are available on the ANSI Webstore. The medical face masks standard is also part of the following standards packages:

ASTM F2100 / BS EN 149 / ANSI/ISEA Z87.1 / ANSI/ASSE Z88.2 – Medical Face Mask Collection

ASTM F2100 / ISO 374-5 / ISO 13688 / ISO 10993-1 – Medical Personal Protective Equipment Package

3 thoughts on “Standard for Medical Face Masks, ASTM F2100-19
  1. If someone wants to make a face mask (“nonmedical” type as mentioned by CDC as a recommendation in April 3, 2020) for the general population and wants to perform the due diligence as a manufacturer, is the ASTM F2100 standard the one to follow, or is it another standard? Or is there any standard?

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.