How to Choose a Face Mask
With many options available, knowing how to select the mask that will give you the right level of protection for the task at hand is an important decision.
Our guide to technical standards for masks aims to simplify this task for you, the consumer. Medical face masks are most often evaluated on either of two global standards. European Standards and American Standards. EN 14683: 2019 and ASTM F2100-19 are the applicable standards for evaluating the performance level of medical face masks.
What is EN?
European Standards (ENs) are documents that have been ratified by one of the three European Standardization Organizations (ESOs), CEN, CENELEC or ETSI; recognized as competent in the area of voluntary technical standardization as for the EU Regulation 1025/2012.
What is ASTM?
The American Society for Testing and Materials (ASTM) publishes technical standards for an expansive array of products, materials, systems and services.
In developing testing standards, both organizations tested material used to make medical face masks on five performance metrics.
Fluid Resistance - Test ASTM F1862
This test evaluates the resistance of a medical face mask to penetration by a small volume (~2 mL) of synthetic blood at a high velocity (80 mmHg, 120 mmHg, or 160 mmHg). The mask either passes or fails based on visual evidence of synthetic blood penetration.
Breathability - Test MIL-M-36954 C: ΔP
This test determines the face mask’s resistance to airflow. A controlled flow of air is driven through the mask, and the pressure before and after is measured. The difference in pressure is divided by the surface (in cm2) of the sample. A lower breathing resistance indicates a better comfort level for the user.
Bacterial Filtration (BFE) - Test ASTM F2101
This test measures the percentage of bacteria larger than 3 microns filtered out by the mask. The challenge material used is Staphylococcus aureus.
Particulate Filtration (PFE) - Test ASTM F2299
This test measures the percentage of particles larger than 1 micron filtered out by the mask. The challenge material used consists of latex aerosol concentrations in a controlled airflow chamber.
Flammability - Test 16 CFR Part 1610: Flame Spread
This test exposes the face mask material to a flame and measures the time required for the flame to proceed up the material a distance of 127 mm (5 inches). Class 1 means the material exhibits normal flammability and is acceptable for use in clothing.
Source: Nelson Labs
Does an ASTM or EN rated mask provide all the protection I need?
A face mask protects your nose and mouth against splashes and sprays of blood and other bodily fluids, as well as bacteria and particulate matter of the sizes indicated in the above table; however, face masks do not provide respiratory protection against airborne diseases. For that purpose, a respirator is required.
Surgical or Non-Surgical?
In general, only masks that conform to EN 14683:2019 Type IIR or ASTM F2100-19 Type 3 are marketed as surgical masks, based on the guidance by government health authorities. For clarity, please always check that the masks you purchase have the published standards that meet the requirements for surgical masks, and do not be afraid to ask the manufacturer for their test certificates.
What is a respirator?
A respirator is a personal protective device that is worn on your face, covers at least your nose and mouth, requires fit-testing, and is used to reduce your risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases or vapors.
One of the most commonly used respirators is aa N95 Respirator mask, which has been tested to filter out 99.9% of airborne particles due to its tight fit around the user’s face. A Surgical N95 Respirator is a N95 Respirator approved by the National Institute for Occupational Safety and Health (NIOSH) in the US that has been cleared by the FDA for use as a surgical mask. Unlike other masks, N95 respirators must be fit-tested for each individual to ensure proper protection.