Surgical Masks Standards Comparison

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Actual Test Results

Standard

EN 14683-2019ASTM F2100-2019YY 0469-2011
Type IType IIType IIRLevel 1Level 2Level 3

Bacteria Filtration Efficiency (BFE) @3μm

≥95%≥98%≥95%≥98%≥95%

≥99%
(For EN Type IIR and ASTM Level 3)

Particle Filtration Efficiency (PFE) @0.1μm

Not Required≥95%≥98%≥30%

≥99%
(For ASTM Level 3)

Synthetic Blood

Not RequiredPass at ≥120mmHGPass at 80mmHGPass at 120mmHGPass at 160mmHGPass at 120mmHG
  • Pass at 120mmHG for EN Type IIR
  • Pass at 16mmHG for ASTM Level 3

Differential Pressure (Breathability)

<40Pa/cm²<60Pa/cm²<5.0mmH2o/
cm²
<6.0mmH2o/cm²<49 Pa/cm²
  • Pass at <60Pa/cm² for EN Type IIR
  • Pass at <6.0mmH2o/cm² for ASTM Level 3

Microbial Cleanliness

≤30 cfu/gNot RequiredNot Indicated≤30 cfu/g

Flammability

Not indicated
(refer to European Medical Directive
(2007/47/EC, MDD 93/42/EEC)

Class 1 (≥3.5 Seconds)Not IndicatedClass 1 (≥3.5 Seconds)

Biocompatibility

  • Skin Sensitisation
  • Skin Irritation
  • In-Vitro Cytotoxicity
Recommended but Not Required
  • Skin Sensitisation
  • Skin Irritation
  • In-Vitro Cytotoxicity

Passed

  • Skin Sensitisation
  • Skin Irritation
  • In-Vitro Cytotoxicity

Ref taken online* updated wef Nov 2020