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

Scope:

ASTM F2100-19 covers performance requirements for materials used to make medical face masks. This specification classifies a range of medical face mask materials based on their performance. 

The list of specified properties represents industry practices for characterizing material performance, but does not include all aspects of performance that may be necessary to protect health care workers. Therefore, this specification does not cover medical face masks for all possible use situations. For example, the Center for Disease Control and Prevention (CDC) specifically requires NIOSH respirators that are at least 95 % efficient for tuberculosis exposure control.

This specification does not evaluate medical face masks. It only evaluates the materials used to make the medical face mask 

This specification does not address all aspects of medical face mask design and performance. It does not evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not evaluate respiratory protection.

Classification:

Medical face mask materials covered under this specification are designated as one or more of the following performance classes: a. General Use, b. Sub-micron Filtering, or c. Fluid Resistant. 

General use medical face mask materials are evaluated for bacterial filtration efficiency and differential pressure. Submicron-filtering medical face mask materials are evaluated for their ability to capture sub-micron particles and are evaluated for bacterial filtration efficiency, and differential pressure. Medical face masks using submicron-filtering materials do not provide respiratory protection to the wearer. Fluid-resistant medical face mask materials are evaluated for resistance to penetration by synthetic blood, submicron particulate filtration, bacterial filtration efficiency, and differential pressure.

Number of Tests: 

A sufficient number of medical face masks should be evaluated for each test to achieve the established acceptable quality limit or confidence level.

Test Methods:

1. Bacterial Filtration Effıciency:
2. Differential Pressure: It determines breathing resistance or differential pressure.
3. Sub-Micron Particulate Filtration: It determines particulate filtration efficiency.
4. Resistance to Penetration by Synthetic Blood: It determines synthetic blood penetration resistance.
5. Flammability: It determines flammability.

Data:

The following information is reported: 

The results of each test used for classifying the medical face mask material to this specification. An optional statement indicating compliance of the medical face mask materials with this specification, including the number, year or issue, and revision letter.