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New ASTM Standard for Face Coverings: ASTM F3502

Table showing the new performance classifications for ASTM F3502 for filtration and breathability

Since February of 2020, we’ve been asking for standards for masks/face coverings used by our communities. Finally, the American Society for Testing and Materials (ASTM) has established a national  standard for “Barrier Face Coverings” (ASTM F3502) that are neither medical masks according to ASTM F2100 standards nor respirators according to NIOSH standards. This new standard establishes minimum requirements for design, performance, and testing that will allow users to compare mask options, and provides mask makers standards to strive for. These standards are not mandatory, but can help distinguish well-tested masks in the marketplace. For home sewists and small manufacturers, the ASTM guidance can help clarify what types of testing to look for in our reading, and clarify testing goals for those headed to the lab.

Topics addressed in this post include:

Note: Numbers in square brackets throughout the text refer to the ASTM F3502 section numbers being referenced. 

Part A: Different Masks for Different Tasks

According to the CDC, masks can be used to protect yourself and to protect others. However, not all masks are created equal. The following table is adapted from the CDC’s comparison of medical masks and respirators and adds information about barrier face coverings that comply with ASTM F3502 to provide a quick comparison of the three types of masks  addressed by standards in the US. Although all of these masks are designed to cover both the mouth and nose, important differences between the mask types exist in terms of intended use, face seal fit, filtration, leakage, and reuse (see table below; click on image or expand text box for details).

Differences between mask types: Barrier Face Coverings, Medical Masks, and N95 Respirators. Graphic adapted from NIOSH, the CDC, and ASTM F3502 by MakerMask.org. Click on the expandable box below the image for the text version of the table

Click here to open text version of the table
Differences Between Common Mask Types
Barrier Face Covering Medical Mask N95 Respirator
Standards (U.S.) ASTM F3502 ASTM F2100 NIOSH 42 CFR Part 84
Intended use/purpose Primarily provides source control to contain the wearer’s respiratory secretions and to potentially reduce exhaled particulates. Also provides a degree of particulate filtration to reduce the amount of inhaled particulate matter Fluid resistant and provides the wearer protection against large droplets, splashes, or sprays of bodily or other hazardous fluids. Also provides source control Reduces wearer’s exposure to particles including small particle aerosols and large droplets (only non-oil aerosols)
Face Seal Fit Snug-fitting Loose-fitting Tight-fitting
Fit Testing Requirement No No Yes
Filtration Filters out at least 20% of airborne particles including large and small particles Does NOT provide the wearer with a reliable level of protection from inhaling smaller airborne particles and is not considered respiratory protection Filters out at least 95% of airborne particles including large and small particles
Leakage Leakage around the edge of the face covering when the user exhales is reduced as shown by an analysis of the product design. Leakage occurs around the edge of the mask when user inhales When properly fitted and donned, minimal leakage occurs around edges of the respirator when user inhales
Reuse May be disposable or reusable. If reusable, laundering instructions must be provided and performance criteria must be met both before and after specified number of laundering cycles. Disposable. Discard after each use. Ideally should be discarded after each patient encounter

Part B: Overview of Barrier Face Coverings: ASTM F3502

What are Barrier Face Coverings?

Barrier Face Coverings that meet the ASTM F3502 requirements are designed to be used by the general public to cover both the mouth and nose with two primary functions:

  1. To provide source control by containing the user’s respiratory secretions and “reducing the number of expelled droplets and aerosols from the wearer’s nose and mouth into the air”
  2. To help protect the user by providing “a degree of particulate filtration to reduce the amount of inhaled particulate matter”

Three Design and Performance Criteria for ASTM F3502

To ensure that barrier face coverings provide these functions, ASTM F3502 establishes design and performance criteria in three general areas: 1) protection, 2) comfort, and 3) reusability.

Performance Area Evaluation Criteria
1. Protection
(for yourself and others)
  • Fit: Design analysis and leakage assessment
  • Filtration: NaCl Aerosol Filtration at 0.3um
2. Comfort
  • Breathability: Air Flow Resistance
3. Reusability
  • Assessment of fit, filtration, and breathability both before AND after maximum number washing/laundering cycles  

 

1. Protection: Fit and Filtration

As described in our “Big Four: Criteria for Fabric Mask Materials” post, breathability and filtration are both key factors in face mask design and materials selection. Unfortunately, the materials that most effectively block droplets and particles typically have poorer breathability, fit, and usability.  Achieving a balance of these four factors is key to good mask design.

Fit

For masks designs that are not focused on creating a tight seal/fit to the face (e.g., pleated medical masks), air can leak around the edges of the mask, carrying unfiltered particles in and out. ASTM F3502 requires masks be designed to fit snugly to the face, covering both the mouth and nose, and reducing gaps. Masks must have a way of being held to the face, and sizing information should be provided. Designs must be analyzed to show that the product reduces leakage around the perimeter of the mask or other areas. Vents or valves are prohibited. [Section 5]

Filtration

In general, masks that provide more filtration offer the user more protection than those that provide less filtration. However, when it comes to filtration testing, results depend strongly on the size of the particles used and specific testing methods. Studies should always be compared “apples to apples” with the same particle sizes, materials, flow rates, and humidity levels.

ASTM F3502 follows the NIOSH procedure for NaCl Aerosols Testing (TEB-APR-STP-0059), using 0.3um particles [Section 8.1]. Importantly, 0.3um is the most highly penetrant size for most materials, making this a worst case filtration test. Filtration performance against larger particles, such as respiratory droplets between 1um and 10um, is generally much higher. 

The ASTM F3502 testing procedure is the same as that used to evaluate filtration performance of NIOSH respirators. While NIOSH respirators may be tested to the N95 standard (95% filtration at 0.3 um), N99 (99% filtration), etc., ASTM F3502-compliant masks can be tested to Level 1 (20% filtration), or Level 2 (50% filtration). 

Importantly, unlike testing for medical masks (e.g., ASTM 2100 and EN14683), breathability and filtration testing for ASTM F3502 is conducted on completed masks rather than fabric samples. This means that results should account for materials, design, and construction techniques.

Face Covering Type Classification Performance
Barrier Face Covering

(ASTM F3502)

Level 1 ≥ 20%
Level 2 ≥ 50%
Respirator

(42 CFR 84)

N95 ≥ 95%
N99 ≥ 99%

Although not required by this standard, ASTM F3502 does allow mask makers to include supplemental information about bacterial filtration efficiency, which evaluates filtration of larger 3 um particles according to ASTM F2101 [9.1.7].  

  • Click here to see the MakerMask testing plan, which includes formal laboratory testing of three-layer fabric masks and material samples using both 0.3um NaCl aerosol testing and 3um Bacterial Filtration Efficiency Testing. We’ll share the results of this testing as soon as we hear back from the lab!

2. Comfort: Breathability

In general, masks that are more breathable are more comfortable and can be worn for longer periods of time. ASTM F3502 establishes testing requirements for mask breathability, which is measured in terms of air flow resistance. This air flow resistance is measured as the difference in pressure as air flows across the mask, where lower pressure changes correspond to more breathable masks. Once again, the testing methods are similar to those required for respirators, with different performance requirements. ASTM F3502-compliant masks have two classifications for breathability: Level 1 (lower performance: 15 mm H2O) and Level 2 (higher performance: 5 mm H2O). Both of these are more breathable than N95s, which are allowed to have air flow resistance as high as 35 mm H2O, and may require pre-use medical evaluation or be uncomfortable for some users [4.1.2; TEB-APR-STP-0007]. 

Face Covering Type Classification Performance
Barrier Face Covering

(ASTM F3502)

Level 1 ≤ 15 mm H2O
Level 2 ≤ 5 mm H2O
Respirator

(42 CFR 84)

N95 ≤ 35 mm H2O

Previous breathability testing conducted on MakerMask prototypes by ATOR Labs provides examples of handmade masks constructed from between one and three layers of quilting cotton and/or nonwoven polypropylene (i.e., “basic fabric masks”) with a breathing resistance of 5.1 ± 1.2 mm H2O (n=7). Our prototype masks designed to provide increased filtration (untested, “fitted fabric masks”) had breathing resistances of 13.5 ± 2.5 mm H2O (n=4). These tests were conducted on a small number of mask prototypes (fewer than the 10 masks required by the new standard). For more information about this breathability testing, see: https://makermask.org/breathable-mask-testing-results/

3. Reusability

Unlike medical masks and respirators, which are certified only for one-time use, the new standard for barrier face coverings provides criteria for reusability. To satisfy these criteria, barrier face coverings must include instructions for laundering, and must demonstrate that they satisfy the requirements for fit, filtration, and breathability both when new AND after the maximum number of laundering cycles specified by the manufacturer. In addition, the service life (maximum number of laundering or cleaning cycles) of the mask must be included on the mask label or package insert [11.1.4].

For those interested in more details on the ASTM standard, the see the Appendix, which takes a deeper dive into the standard and the testing requirements.

Part C: What does this standard mean for mask users, sewists, and mask?

Relevance for Mask Users

In the near future you may be able to walk into a store or hop online and buy masks that are advertised as compliant with ASTM standards, and which provide performance levels for filtration and breathability. Such labels will allow for more informed comparison shopping across a wide range of designs and materials. 

In general, masks with Level 2 filtration will offer better protection than those with Level 1 protection, and masks with Level 2 breathability will be more comfortable to wear than masks with Level 1 breathability. However, in most cases masks with higher filtration performance will have lower breathability (i.e., comfort) levels. 

Classification
Level 1 Level 2
Filtration: Sub-micron particulate filtration efficiency (~0.3 um)

 

≥ 20% ≥ 50%
Breathability: Air flow resistance

 

≤ 15 mm H2O ≤ 6 mm H2O

Relevance for Sewists and Makers

Face coverings that are compliant with these new standards are most likely to be produced by medium-to-large scale manufacturers that have the resources and access to accredited testing labs required to be in compliance with all the ASTM F3502 standards described above (see the Appendix for additional details on testing costs etc). However, this does not mean that sewists should stop making masks, nor does it mean that there is nothing useful in these standards for sewists and small-scale mask makers.

The Standard is Not Mandatory

First, it’s important to note that these standards are not mandatory and mask makers are not required to comply with them. At this point, we have no idea whether or not these standards will be broadly adopted by large scale manufacturers, or whether certified masks will be required for public use.

The Standard Asserts the Importance of Fit, Filtration, and Breathability

Second, although the standard doesn’t provide specific guidance on mask materials or designs, it does assert the importance of mask fit, and it establishes testing requirements and performance criteria for masks in terms of both filtration and breathability. Although testing the 10 or 20 masks required by the standard (to the tune of $2000 to $4000) may not be feasible for many, testing one or two masks (to the tune of $200 to $400) is more approachable and may provide important context for how a given mask performs relative to the standards. 

MakerMask continues to follow these standards closely, and is testing prototypes using two different fabric combinations. Although this will not fully satisfy the requirements of ASTM F3502, it will provide us with representative data to compare the performance of our masks with others. We look forward to more scientific studies that leverage this standard and allow for “apples to apples” comparisons!

The Standard Can Be Used to Inform Best Practices

Finally, the ASTM standard can be used to inform ‘best practices’ for mask makers in terms of the type of information they should include with their masks:

Final Thoughts

For those curious about how the ASTM F3502 testing requirements compare to other mask and respiratory standards, they are summarized in the figure below:

Comparison of mask standards in the U.S. and Europe including the new ASTM standard for barrier face coverings.

[Edit (April 21, 2021)] For information about the performance of spunbond nonwoven polypropylene (NWPP) in fabric mask layering combinations (either NWPP-NWPP-NWPP or Cotton-NWPP-NWPP) compared to the test requirements used for ASTM F3502 and ASTM F2100 click here for the MakerMask Fabric Mask Testing Results Post.

Appendix: Digging into the Details of the ASTM Standards

For those interested in the details of what is and is not required by the new ASTM standard, especially in terms of testing. This appendix dives into some of the details.

What products does this standard cover?

ASTM F3502-compliant barrier face coverings are:

  • Designed to fit snugly to the face, covering both the mouth and nose, and reducing gaps [Section 5.1.1]
  • Primarily intended for use as source control and are not considered medical masks or respirators [Sections 5.1.5 and 10.2]
  • Can be either disposable and reusable coverings [Sections 5.1.5 and 10.2].
What are the Testing Requirements?

To be considered ASTM F3502-compliant, the covering must be tested by an accredited lab, meet minimum requirements for particle filtration and breathability, and comply with guidance for design, labeling, user instruction, reporting and classification, and conformity assessment.

Testing Performance:

To qualify as ASTM F3502-compliant, the minimum criteria (Level 1) for both sub-micron particulate filtration efficiency of 20% and air flow resistance 15 mm H2O must be met. In addition, a higher performance criteria (Level 2) for filtration is available for masks with 50% filtration efficiency. For breathability, Level 2 performance classification is available for masks with an air flow resistance of 6 mm H2O. It is important to note that filtration and breathability are evaluated separately, so it is possible to have Level 1 filtration and Level 2 breathability and vice versa. Classifications are based on the poorest results of all tested samples.

Testing Requirements:

For this new ASTM F3502 standard, both the breathability and filtration can be tested on the same face coverings. To satisfy the requirements for reusable face coverings, testing needs to be conducted on a total of 20 masks: 10 face coverings tested when new, and 10 face coverings tested after the maximum number of laundering cycles specified by the maker/manufacturer (see Table below). This testing needs to be performed by an accredited lab if compliance with the standard is claimed.

Required Tests Number of Masks Tested Approximate Cost of Testing
New After Washing Cycles Total
NaCl Aerosol Testing:

  • Sub-micron particulate filtration efficiency (~0.3um)
  • Air flow resistance
10 10 20 $4000 – $5000

Testing Details: For this standard, both filtration and breathability are tested using one piece of equipment: the TSI 8130 or TSI 8130A. This $80,000 equipment is the industry standard for NaCl aerosol testing of sub-micron particle filtration. For reusable masks, commercial testing typically runs roughly $4000 for full ASTM F3502-compliant testing at the time of this publication.

Check out the video of the TSI 8130A in action below (skip to 1:20 to see demo).

 

Deeper Dive: Test Methods and Requirements for ASTM F3502

Filtration Test Methods. Testing should be conducted using NaCl aerosols according to Subpart K of 42 Code of Federal Regulations (CFR) Part 84 (see TEB-APR-STP-0059). The lowest measured PFE of the tested masks is used to determine compliance with the standards. Note: “For products with inserts, the area around the insert shall be included in the specimen area to be tested.”

Breathability Test Methods. “A face velocity of 10±0.5 cm/sec shall be used. The specimens shall be tested at a flow rate of 85 ± 4 Lpm. If the specimen lays flat in the filter holder, adjust the flow rate to achieve a face velocity of 10 cm/sec. For example, with a filter area that has an area of 100 cm2, the challenge flow rate would be approximately 60 Lpm to achieve the face velocity of 10 cm/sec.” The highest measured airflow resistance of the tested masks is used to determine compliance with the standards.

Testing Facility: “For the purposes of claiming that a product meets this specification, testing for sub-micron particulate filtration efficiency and air flow resistance specified in Section 8 shall be performed by a laboratory that is accredited in accordance with the requirements of ISO/IEC 17025 where the laboratory’s scope of accreditation encompasses the specific tests within this specification.”

Note: Unlike testing for medical masks (e.g., ASTM 2100 and EN14683), breathability and filtration testing for this standard (ASTM F3502) is conducted on completed masks and not on fabric samples.

Fit: Design Requirements

In addition to quantitative evaluation of breathability and filtration, the new guidance establishes a number of additional design requirements that should be addressed in a report they refer to as the “Product Design Analysis Self-Declaration”. The emphasis of the design analysis is on mask fit, and the strategies used to minimize the leakage of exhaled air around the mask, however, the appropriateness of mask materials and flammability are also addressed. 

Some of the primary design considerations for fit include:

  • Should be designed to cover the mouth and nose and fit snugly to the face [Section 5.1.1]. 
  • Design features should reduce leak and minimize the flow of air around the face covering and should not include valves or vents [Sections 5.1.6 and 5.1.7]. 
  • Retention System (Ties, loops, head harnesses et al.) should be designed to hold the BFC in place throughout the range of activities typical of usage and can include plastic toggles or slides to improve individualized fit [Section 5.2.1].
Fit: Reporting Requirements

The new standard requires a design analysis declaration report that includes a Leakage Assessment, which evaluates the leakage of air around the mask both when the mask is new AND after the maximum number of washing cycles. The Leakage Assessment can be done:

  • Mathematically, through modeling, through conformance to AATCC M14-2020 sizing characteristics, 
  • Or through quantitative fit testing of the masks according to ASTM F4307  [Section 5.4.1 and Section 8.3]. If quantitative assessment through ASTM F4307 is used, the leakage ratio is calculated as the average across the 10 participants and should be calculated for both the new and laundered BFC.

Deeper Dive: Other Design Requirements

Consistent with the FDA EUA on face coverings, the ASTM standard also includes information about skin contacting materials and flammability.

Skin Contacting Materials: BFCs should be constructed from nonirritating and nontoxic materials [Section 5.1.2]. The standard recommends using materials that have previously been tested and demonstrated nonirritating/nontoxic. However, is that information isn’t available it can be tested according to existing standards for masks and/or textiles. For example, ISO/ANSI/AAMI 10993-10: Tests for Irritation and Skin Sensitization (~ $11,000) and ISO/ANSI/AAMI 10993-5: Tests for Cytotoxicity (~ $500).

Flammability: The standard also specifies that face coverings should be constructed from materials that DO NOT pose a flammability hazard. Flammability testing for textile-based coverings are subject to 16 CFR 1610, ~$400 – $9000) [Section 5.1.3]. Although not referenced in the standard, the language recommended by the FDA in their guidance on face masks suggests wording that products that haven’t been tested for flammability be “labeled with a recommendation against use in the presence of high intensity heat source or flammable gas.

What Information is Included in the Formal Report of Testing Data?

The information required in the testing report provides a recap on the important elements required to satisfy the ASTM criteria for barrier face coverings.

Test Report Information:

  • Manufacturer’s Name:
  • Product Name/Model:
  • Test Laboratory Name and Accreditation Credentials:
  • Reportable Testing Information
    • Sub-Micron Particulate Filtration Efficiency [Section 8.1]
    • Air Flow Resistance [Section 8.2]
  • Product Design Analysis
  • Description of Laundering/Cleaning Process (if reusable)
  • Supplemental Testing Data (optional)
    • Optional: Average BFE when tested in accordance with ASTM F2101 [Section 9.1.7]
    • Optional: Quantitative Leakage Assessment Testing [Section 8.3; Section 9.1.8]
  • Classification (i.e., Level 1, Level 2)
What are the Labeling Requirements?

For masks that pass ASTM F3502-compliant testing and reviews, the standard provides additional information and guidance on labeling. This includes the specific labeling information for labels/tags on each face covering, information to be included on the mask package, and finally the information to be included in the package insert for each mask.

This information must include donning and doffing instructions. In addition, for reusable masks care and use instructions as well as instructions for laundering or cleaning the face coverings, and the service life (maximum number of launderings or cleanings cycles) appropriate for each face covering must also be included. For example, the package insert should include the following information:

The package insert/instructions should include the following information

  1. The manufacturer, product, and compliance information, and warning statements [Section 10.2]
  2. Information on how to select the correct size and make adjustments in the fit (if applicable).
  3. Procedures for donning (how to put on) and doffing (how to take off)
  4. If the product is reusable then inspection, use, and care instructions, including laundering or cleaning and the service life (maximum number of launderings or cleanings cycles) shall be included. Information on how to prepare these care and use instructions can be found in 16 CFR Part 423 as well as in the Guides: D3938 and D5489.
  5. Any other cautions and limitations (e.g., barrier face coverings should not be placed on very young children (< 2 years) or anyone who has trouble breathing, or anyone who is unconscious, incapacitated or otherwise unable to remove the barrier face covering without assistance, etc.)
  6. Conditions of storage and the shelf life, if applicable or known (if stored without use).
  7. How to tell when the barrier face covering has reached the end of its useful life (i.e., when it should be replaced).
  8. Procedures for disposal of product following use.

Reference

ASTM F3502-21, Standard Specification for Barrier Face Coverings, ASTM International, West Conshohocken, PA, 2021, www.astm.org

ASTM International has granted free access to COVID-19 related standards including the new ASTM F3502 standard. Click here for more information

 

New ASTM Standard for Face Coverings: ASTM F3502

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