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) 4.4.1.2 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 CFU/g	coli group	Pseudomonas aeruginosa	Staphylococcus aureus	hemolytic streptococcus	fungus colony CFU/g
≤20	No detection	No detection	No detection	No detection	No detection