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. For US hospital procurement, Level 2 or 3 is the common specification.

• Level 1: low fluid resistance, general use
• Level 2: moderate fluid resistance
• Level 3: highest fluid resistance for surgery
• Level 2 or 3 is the common US hospital spec

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). For European export, Type IIR with 120 mmHg splash resistance is the surgical standard.

• Type I: general patient use
• Type II: healthcare professional use
• Type IIR: splash-resistant for surgery
• Type IIR is the standard for European surgical export

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, and GB 2626 covers respirators such as KN95.

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 rather than assuming cross-standard equivalence.