Making Enhanced Performance Barrier Face Coverings
Guidance for Manufacturers on Enhanced Barrier Face Coverings Which Build Upon the ASTM International (ASTM) Standard
Version 2.0 — June 2023
The ASTM Specification for Barrier Face Coverings, F3502-23a (ASTM Standard) establishes a baseline for a source control device and allows for comparison between products. BFCs provide source control by reducing the number of expelled droplets and aerosols from the wearer’s nose and mouth into the air. They also potentially offer a degree of particulate filtration to reduce the amount of inhaled particulate matter by the wearer.
NIOSH provides performance recommendations for enhanced barrier face coverings (BFCs), called Enhanced Performance and Enhanced Performance Plus BFCs. BFCs meeting the enhanced recommendations provide a higher level of performance to help prevent the spread of respiratory viruses. They use enhanced particulate filtration, breathability, and leakage recommendations.
It’s important to note that no BFCs, even enhanced BFCs, can replace NIOSH Approved® respirators within a workplace respiratory protection program. Also, performance of BFCs for each person cannot be guaranteed as testing is specific to the BFC, not the individual wearer.
This guidance assists manufacturers with designing and producing BFCs that meet the ASTM Standard criteria and enhanced performance recommendations. To be considered an Enhanced Performance or Enhanced Performance Plus BFC, products must meet the ASTM Standard:
- Criteria for product design
- Performance criteria for:
- Filtration efficiencies at an enhanced level
- Breathability at an enhanced level
- Leakage at an enhanced level
- Criteria for testing and conformity assessment
These products must also meet additional recommendations from NIOSH for:
- Product labeling
- Assuring consistent quality within the conformity assessment process
The ASTM Standard design requirements state BFCs must:
- Cover the wearer’s nose and mouth.
- Fit snugly against the sides of the face and nose without gaps, as determined by the design analysis.
- Have a means for keeping the BFC over the nose and mouth. This includes during the expected duration of use and range of activities.
- Use non-irritating and nontoxic materials where the BFC contacts the skin.
- Be either disposable (single use) or reusable (multiple use).
- Allow individuals with a range of fit characteristics (excluding children under age 2) to wear it. Alternatively, BFCs can have multiple sizes to allow fit for a wide variety of people.
NIOSH does not specify any additional design recommendations for Enhanced Performance and Enhanced Performance Plus BFCs.
The ASTM Standard performance criteria address filtration, breathability, and leakage. NIOSH adds enhanced recommendations for Enhanced Performance and Enhanced Performance Plus BFCs. The following table includes the recommended enhanced performance levels.
|Type of BFC
|Enhanced Performance BFC
|ASTM F3502 Level 2 at ≥50%
|ASTM F3502 Level 1
|Leakage ratio of ≥5
|Enhanced Performance Plus BFC
|ASTM F3502 Level 2 at ≥80%
|ASTM F3502 Level 1
|Leakage ratio of ≥10
*A higher leakage ratio number means that fewer particles escape around the edges. This indicates products provide better source control across users with a variety of facial sizes.
Testing requirements for BFCs helps ensure that they meet design and performance requirements. An ISO-17025 accredited laboratory must carry out the filtration efficiency and breathability testing. The accredited laboratory must follow the methods in Section 8 of the ASTM Standard.
Manufacturers should use a modified version of the test procedure in the ASTM Standard to test for the leakage ratio requirement. The ASTM Standard Test Method for Respirator Fit Capability for Negative-Pressure Half-Facepiece Particulate Respirators, F3407-21 describes the test procedure.
- Filtration efficiency
Manufacturers must test BFCs according to Section 8.1 of the ASTM Standard. Enhanced BFCs must meet the filtration efficiency level 2 at the following filtration efficiencies:
- Enhanced Performance BFC: 50% or greater
- Enhanced Performance Plus BFC: 80% or greater
Manufacturers must test BFCs according to Section 8.2 of the ASTM Standard. Enhanced Performance and Enhanced Performance Plus BFCs must meet the breathing resistance requirements for Level 1 (≤15 mm H20).
Manufacturers must test BFCs according to ASTM F3407-20 Standard, using the modifications detailed in Section 8.3 of the ASTM Standard. The modifications reduce the number of population-representative cells, or face sizes, required. The leakage ratio is the number of particles outside the BFC compared to the number inside the BFC. BFCs must meet the following leakage ratios:
- Enhanced Performance BFC: 5 or greater
- Enhanced Performance Plus BFC: 10 or greater
Manufacturers must label BFCs and packaging (smallest unit or package) according to the ASTM Standard. The Enhanced Performance and Enhanced Performance Plus BFCs and packaging must include the following additional wording:
- Enhanced Performance BFCs: “MEETS ENHANCED PERFORMANCE”
- Enhanced Performance Plus BFCs: “MEETS ENHANCED PERFORMANCE PLUS”
BFCs need to meet all of the ASTM Standard criteria as well as the enhanced performance and additional recommendations before manufacturers can label them as meeting the enhanced recommendations. Manufacturers must provide user instructions with the smallest saleable unit or package according to the ASTM Standard.
Note: BFCs meeting these recommendations before June 2023 were labeled “MEETS WORKPLACE PERFORMANCE” and “MEETS WORKPLACE PERFORMANCE PLUS.” Enhanced performance and additional recommendations, other than labeling, did not change.
A conformity assessment addresses how BFCs meet the ASTM Standard. ASTM compliant BFC manufacturers must:
- Apply “Model A” requirements of ASTM F3050-22a, Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment.
- Set the frequency of testing.
- Address product quality.
- Perform filtration efficiency and airflow resistance in an ISO-17025 accredited laboratory.
Quantitative leakage testing is not subject to the conformity assessment requirement. However, a manufacturer may choose to perform the testing. Quantitative leakage testing is a requirement for the Enhanced Performance and Enhanced Performance Plus BFCs, even though it is an option in the ASTM Standard.
The ASTM Standard permits manufacturers to meet more rigorous requirements for a conformity assessment (3rd party certification).
ASTM . F3502-23a Standard Specification for Barrier Face Coverings. West Conshohocken, PA: ASTM International.
ASTM . ASTM F3050-22a Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment. West Conshohocken, PA: ASTM International.
ASTM . ASTM F3407-21 Standard Test Method for Respirator Fit Capability for Negative-Pressure Half-Facepiece Particulate Respirators. West Conshohocken, PA: ASTM International.
ASTM has granted free access to COVID-19 related standards including the ASTM F3502-23a Standard.
NIOSH Approved® is a registered certification mark of the U.S. Department of Health and Human Services (HHS).
Version 2.0 June 2023 NIOSH updated these recommendations to change the name of the enhanced performance BFCs from Workplace Performance Mask and Workplace Performance Plus Mask to Enhanced Performance Barrier Face Covering and Enhanced Performance Plus Barrier Face Covering and labeling recommendation. NIOSH also updated references to the current version of ASTM standards and made it easier to see where we make enhanced and additional recommendations.
Version 1.0 May 2021 First issuance of recommendations.