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 F2100-20: 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 F2100-20 document for testing procedures and other specific requirements.
Application of ASTM F2100-20
Covering the minimum performance requirements for materials, ASTM F2100-20 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 F2100-20 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 F2100-20 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 F2100-20:
- ASTM F1494-14: Standard Terminology Relating To Protective Clothing
- ASTM F1862-17: Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- ASTM F2101-19: Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus
- ASTM F2299-03(2017): Standard Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres
- ANSI/ASQC Z1.4-1993: Sampling Procedures And Tables For Inspection By Attributes
- ISO 2859-1:1999 – Sampling Procedures For Inspection By Attributes — Part 1: Sampling Schemes Indexed By Acceptance Quality Limit (AQL) For Lot-By-Lot Inspection
- BS EN 14683:2019 – Medical Face Masks. Requirements And Test Methods (British Standard)
- 16 CFR Part 1610 – Standard for the Flammability of Clothing Textiles
- 21 CFR Section 878.4040 Surgical Apparel
- 1910.1030 – Occupational Exposure to Bloodborne Pathogens
- 42 CFR Part 84 Respiratory Protective Devices
Many of these standards and ASTM F2100-20: 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
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?
can the manufacturer issue the date sheet for astm f2100
Are these good for Covid? I have a box of Level 1.
Is Level 1 or Level 3 better?