ASTM F2100-19
Standard Specification for Performance of Materials Used in Medical Face Masks

Standard No.

ASTM F2100-19

Release Date

2019

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2100-19e1

Latest

ASTM F2100-23

Scope

1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. 1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. 1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not apply to regulated respiratory protection, which may be necessary for some healthcare services. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 The following precautionary caveat pertains only to the test methods portion, Section 9, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F2100-19 Referenced Document

• ASTM F1494 Standard Terminology Relating to Protective Clothing
• ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)*， 2024-04-21 Update
• ASTM F2101 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus*， 2023-03-01 Update
• ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres*， 2024-04-21 Update
• ISO 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1

ASTM F2100-19 history

• 2023 ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2021 ASTM F2100-21 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2020 ASTM F2100-20 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2019 ASTM F2100-19e1 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2019 ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2011 ASTM F2100-11(2018) Standard Specification for Performance of Materials Used in Medical Face Masks
• 2011 ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2007 ASTM F2100-07 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2004 ASTM F2100-04 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2003 ASTM F2100-03a Standard Specification for Performance of Materials Used in Medical Face Masks
• 2003 ASTM F2100-03 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2002 ASTM F2100-02 Standard Specification for Performance of Materials Used in Medical Face Masks
• 2001 ASTM F2100-01 Standard Specification for Performance of Materials Used in Medical Face Masks