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Must-have test items for medical mask November 6,2020.

Testing requirements for medical masks

Medical masks need to undergo mask molding, pressing, edge trimming, ear strap spot welding, nose bridge line fitting, packaging, bacteria filtration, particle filtration, blood penetration and air flow resistance & differential Pressure.

The testing of medical mask products includes factory inspection and type inspection.

Test Procedure:

The factory inspection items should have at least the following items: appearance, structure and size, nose clip, bacteria filtration indicators, particulate filtration indicators, blood penetration indicators; air flow resistance& differential pressure indicators.

Type inspection should be a full performance inspection of product standards.


Bacteria filtration of medical masks:

According to relevant regulations, the bacterial suspended particle content index of medical masks under the specified flow rate must meet the standard. Inspection departments, scientific research institutes, medical mask manufacturers and other relevant departments must improve sampling accuracy and test the performance of bacterial filtration efficiency of medical surgical masks.

But many factory could not produce the mask totally meet the requirement of this, so need to check the indicator by the BFE to ensure could meet the requirement.

Reference Standard of BFE%:

ASTM 2101

EN 14683:2019

LEVEL 1

LEVEL 2

LEVEL 3

Type I

Type II

Type IIR

≥95

≥98

≥95

≥98


Particulate indicator test of medical mask:

According to relevant regulations, medical masks must pass the test of particle filtration efficiency to determine the resistance of ordinary fabrics and medical protective masks to constant airflow. Particulate filtration efficiency is measured by measuring the particle concentration of the airflow tested before and after passing through the respirator and by subsequent calculations. The size distribution of the test particles is represented by the count median diameter.

The PFE tester could help to ensure the mask can meet the requirement.

Reference Standard of PFE%:

ASTM 2101

EN 14683:2019

LEVEL 1

LEVEL 2

LEVEL 3

Type I

Type II

Type IIR

≥95

≥98

Not required


Blood penetration test of medical mask:

According to relevant regulations, medical masks must meet the required standards for the penetration of synthetic blood splashes. Manufacturers of medical masks should measure the penetration of the masks to synthetic blood and other liquid-derived injections under continuous applied pressure, in order to evaluate their safety and protective performance.

Reference Standard of Splash resistance pressure:

ASTM F 1862

EN 14683:2019

LEVEL 1

LEVEL 2

LEVEL 3

Type I

Type II

Type IIR

80 mmHg

120 mmHg

160 mmHg

Not required

≥16.0kpa


Air flow resistance& differential pressure test of medical mask

The air flow passes through a certain area of the medical mask, and the current pressure should be detected by the pressure sensor. The calculated result is the pressure difference. According to relevant regulations, medical masks must be tested for air flow resistance and differential pressure in order to check their breath ability. In case the manufactured medical mask can not meet the requirement, the manufacturer can test the mask by a Air flow resistance& differential pressure tester.

Reference Standard of differential pressure:

ASTM F 2100-2019

EN 14683:2019

LEVEL 1

LEVEL 2

LEVEL 3

Type I

Type II

Type IIR

5.0H2O/cm²

6.0H2O/cm²

40Pa/cm²

60Pa/cm²



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