What‘s the ASTFM2100 Level-3 standard for surgical mask?

The ASTM F2100 standard, formally known as the Standard Specification for Performance of Materials Used in Medical Face Masks, is a widely recognized standard in the United States and globally that defines the required performance characteristics for medical face mask materials. It categorizes masks into three levels based on their protective capabilities: Level 1 (lowest protection), Level 2 (moderate protection), and Level 3 (highest protection).

Key Requirements for Level 3 Masks

ASTM Level 3 masks offer maximum barrier protection and are intended for use in situations with a high risk of fluid exposure (heavy levels of spray, splatter, or aerosols).

A mask must meet stringent requirements in five key areas to achieve the Level 3 designation:

About Requirements:

• Fluid Resistance (160 mmHg): This is the most significant differentiating factor for Level 3. It means the mask can resist synthetic blood penetration at a high pressure (160 mmHg), which correlates with high-pressure scenarios such as trauma or surgical procedures involving high-pressure irrigation (e.g., orthopedics).

• Filtration Efficiency (BFE & PFE): Both the Bacterial Filtration Efficiency and Particulate Filtration Efficiency must be >98%. This indicates a high capability to filter out airborne particles, including bacteria and sub-micron particles.

• Differential Pressure (Delta P): This measures the air resistance, or breathability, of the mask. A value of <6.0mmH₂O/cm² indicates that while the filtration is high, the mask remains acceptably breathable for the user.

• Flammability (Class 1): The mask material must pass a test to ensure it does not easily ignite or spread a flame, which is critical in an operating room environment.

ASTM Level 3 masks are recommended for high-risk procedures where heavy exposure to blood, body fluids, aerosols, or sprays is anticipated. Common examples include:

• Major surgeries.

• Procedures involving high-speed devices or significant fluid generation.

• Trauma cases.

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