Site: Home > Home > News and events

International Standards For Medical Face Mask Testing

2020-03-30 17:39

      BS EN 14683:2019 specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.

EU Standard: EN 14683 – 2014

Testing items Type Ia Type II Type II R Test method
BFE(%) ≥95 ≥98 ≥98  
pressure difference (Pa/cm²) 29.4 29.4 49.0  
Hemodialysis (KPa) non non ≥16(120mmHg) ISO 22609
Microbial cleanliness (cfu/g) ≤30 ≤30 ≤30 ISO 11737 – 1

Remark: Test at least 5 samples. 32 masks, no more than 3 through the blood.

ASTM F2100-2004 covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. 
US Standard: ASTM F2100-2004

performance index Low barrier Moderate barrier High barrier
BFE(%) ASTM F2101


(28.3LPM·3.0μm Glucose bacterial particles)

≥95 ≥98 ≥98
Pressure difference (mmH2O/cm²) of MIL-M-36954C (8.0LPM)

<4.0 <5.0 <5.0
PFE(%) 0.1μm emulsion particle


ASTM F2299

Not required ≥98 ≥98
Hemodialysis (mmHg)


ASTM F1862, ISO 22609

80 120 160
Flame resistance  16CFR Pat 1610 Class 1 Class 2 Class 3

YY 0469 – 2004 (medical surgical mask)


YY 0469 – 2004 (medical surgical mask)

performance index BFE(%) PFE(%) Obstruction (pa) Hemodialysis (mmH2O) Remarks
Requirement 95 30 49 120 dip water grade 3
bacterial colony



coli group Pseudomonas aeruginosa Staphylococcus aureus hemolytic streptococcus fungus colony



≤20 No detection No detection No detection No detection No detection

Related News

2023-10-26How do you measure oxygen levels in an experiment?
2023-10-26What is ASTM D6413?
2023-10-26What is ASTM D 695 standard test method for compressive properties of rigid plas
2023-10-26What types of construction materials are covered by ASTM standards?
2023-10-25Differences in the testing procedures between ASTM D2863 and ASTM D2863 17
2023-10-25What is the test method for limiting oxygen index?
2023-10-24What is 50% stretch in fabric?
2023-10-24How do you test fabric quality?
2023-10-24How are the materials are tested as per ASTM standards?
2023-10-24Can the oxygen index test be used to compare the fire resistance properties of d

Copyright 2022:Qinsun Instruments Co., Limited

High-end textile tester supplier | Textile Testing Equipment pdf | Tel:021-67800179 |