International Standards For Medical Face Mask Testing
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 |
2020-03-30 17:39
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