ASTM Standards Update

What is changing with the ASTM standards?

The ASTM standard for medical masks is transitioning from ASTM F2100-21 to ASTM F2100-23. In Canada, no specific implementation date has been mandated, however it will be effective July 2025 in the USA. The primary change impacts Particle Filtration Efficiency (PFE) testing, introducing new testing methods and updated PFE levels.

How are the PFE levels different under the new standard?

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.

Does this mean mask quality has decreased?

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.
• PRIMED masks already exceed both old and new standards, so you can continue to rely on the same high level of protection.
  ‍

How will this change impact me as a user?

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

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

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

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

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.
‍

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

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.
‍

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

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).
  ‍

How do these changes improve patient and staff safety?

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.
  
• Reduce the risk of misunderstanding mask capabilities in critical situations.
  ‍

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

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

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

Yes, PRIMED 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.
‍

When will this change take effect?

The transition to ASTM F2100-23 will take effect in July 2025 in the US. Canadian regulators have not indicated a specific transition date at the time of writing. Manufacturers like PRIMED are already compliant with the new standards.
‍

How can I learn more about this transition?

Visit our website or scan the QR code below for detailed information about the ASTM transition and how it impacts medical mask performance.
‍