Medical Mask Standards Comparison

ASTM F2100 (North America)

ASTM F2100 grades surgical masks into three levels (1, 2 and 3) based on bacterial filtration efficiency, particulate filtration, differential pressure (breathability) and fluid resistance. Level 3 offers the highest fluid resistance for high-risk procedures.

• Level 1: low fluid resistance, general use
• Level 2: moderate fluid resistance
• Level 3: highest fluid resistance for surgery

EN 14683 (Europe)

EN 14683 classifies medical face masks as Type I, II or IIR. Type IIR adds splash resistance and is the type used in surgical settings. The standard measures bacterial filtration efficiency and breathability (differential pressure).

• Type I: general patient use
• Type II: healthcare professional use
• Type IIR: splash-resistant for surgery

GB standards (China)

Chinese standards such as GB/T 32610 and YY 0469 define requirements for daily protective masks and medical surgical masks. YY 0469 is the standard for medical surgical masks used in clinical settings.

How to read a mask label

Check the standard, the level or type, and the key performance numbers (BFE, fluid resistance, differential pressure). A mask that meets a higher level under one standard may not be equivalent under another, so match the standard to your target market.