What is changing with the ASTM standards?

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The ASTM standard for medical masks is transitioning from ASTM F2100-21 to ASTM F2100-23. This change came into effect in July 2025. The primary change impacts Particle Filtration Efficiency (PFE) testing, introducing new testing methods and updated PFE levels.

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How are the PFE levels different under the new standard?

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The PFE levels for medical masks are updated to reflect the requirements of a new test method that provides more reproduceable results from lab to lab and is closer to the method used for N95 testing.

Why was the testing method changed?

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The old test method, ASTM F2299, allowed some leeway in the test method parameters meaning lab to lab variation could lead to confusing or inconsistent results. The new method, ASTM F3502, uses a fixed particle size of 0.3 microns (often called the most penetrating size) and a fixed flow rate providing more repeatable results. This change also makes mask performance more comparable to NIOSH N95 respirators, improving transparency and user understanding.

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Does this mean mask quality has decreased?

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No, the quality of masks has not decreased.

• The new ASTM standards ensure testing consistency and accuracy. It does not mandate any changes to mask construction or materials.
• The new specifications for PFE were based on the change to the test method and by analyzing masks on the market.
• VIVIT Supply masks already exceed both old and new standards, so you can continue to rely on the same high level of protection.

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How will this change impact me as a user?

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• Improved Clarity: You’ll have a better understanding of the true protection levels of your mask.
• Same Quality: VIVIT Supply masks remain just as protective as before—no changes are needed to the masks themselves.

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Will the new ASTM standard affect the masks I currently use in acute care?

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No, the masks you currently use will remain effective. VIVIT Supply manufactured masks have been tested to meet the new ASTM F2100-23 standards, ensuring continued protection without changes to the mask itself.

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How does this change affect mask selection in high-risk environments?

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The updated ASTM levels clarify the true filtration capabilities of masks, making it easier to choose the appropriate level of protection for your environment. For high-risk procedures, N95 respirators or Level 3 masks are still recommended, depending on exposure risks.

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Are masks with lower PFE levels under the new standard less protective?

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No The 80% (Level 1) and 85% (Level 2/3) PFE ratings reflect more the new more rigorous test method. The actual performance of the mask hasn’t changed, only how it’s measured.

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Will this change the type of mask I should wear for different procedures?

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No, the selection criteria for masks remain the same:

• Level 1: Low-risk environments (e.g., basic patient care).
• Level 2: Moderate-risk environments (e.g., suturing, oral exams).
• Level 3: High-risk environments (e.g., surgical procedures, fluid exposure).

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How do these changes improve patient and staff safety?

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By introducing more accurate and consistent testing methods, the new ASTM standards:

• Provide greater confidence in mask performance.
• Align closer to NIOSH respirator testing standards, making it easier to compare products.
• Align closer to NIOSH respirator testing standards, making it easier to compare products.

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Do I need to stock different masks to prepare for the change?

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No, there’s no need to stock different masks. VIVIT Supply manufactured masks have been tested to meet the new ASTM F2100-23 standards, ensuring we continue to provide reliable protection.

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Are VIVIT Supply masks still compliant with infection control standards in acute care?

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Yes, VIVIT Supply masks meet or exceed both current (F2100-21) and new (F2100-23) ASTM standards. They remain fully compliant with infection control protocols for acute care settings.

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When did this change take effect?

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The transition to ASTM F2100-23 took effect in July 2025. Manufacturers like VIVIT Supply are compliant with the new standards.

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Helpful Resources to share with your team:

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We have put together three resources that you can share with your team to ensure they stay up-to-date with the latest ASTM changes.

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The ASTM Standards booklet helps you understand what’s behind the standards that define medical mask performance. It breaks down the key ASTM F2100 criteria: Bacterial and Particulate Filtration Efficiency, Breathability, Fluid Resistance, and Flame Spread in clear, practical terms.

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Designed for healthcare professionals and purchasing teams, this guide simplifies the science behind mask testing and protection levels (ASTM Levels 1, 2, and 3), helping you make informed choices for every clinical setting. It also explains how biocompatibility testing ensures safety and comfort for wearers.

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Whether you’re evaluating products or educating your team, this booklet is your quick reference to understanding what makes a medical mask truly protective—and why it matters.

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