en 14683:2019 + AC:2019

EN 14683, a European standard, describes the requirements and testing methods of medical face masks. It’s most recent publication is EN 14683:2019+AC:2019 Medical face masks - Requirements and test methods.

The standard lays down guidelines in the design, production, performance requirements as well as test methods of medical face masks in order to limit contamination. It strictly regulates Bacterial Filtration Efficiency (BFE), Breathability (Pressure Drop) and Microbial Cleanliness.

Bacterial Filtartion Efficiency, the resistance of a material to bacterial/other microorganism penetration. It can be performed on masks and filtering media to evaluate the level of protection against biological aerosols. The main sources of contamination during operations are mounth, nasal cavities of the employees. During epidemics, it can prevent spreading of the infectious diseases.

EN 14683 standard performance tests includes tests for:

• In vitro evaluation of bacterial filtration efficiency

• Air permeability (differential pressure) test

• Microbial cleanliness test

• Splash resistance test under ISO 22609 standard  (only for Type IIR masks)

• Biocompatibility tests (optional)

The requirements are as follows:

   

Test	Type I	Type II	Type IIR
Bacterial filtering efficiency	≥95%	≥98%	≥98%
Differential pressure	<40 Pa/cm2	<60 Pa/cm2	<60 Pa/cm2
Splash resistance	-	-	At least 16,0 kPa
Microbial cleanliness	Up to 30 Cfu/g	Up to 30 Cfu/g	Up to 30 Cfu/g

The filtering efficiency and protective power of a face mask can be compromised when the mask is wet, torn or removed. Rule of thumg is the higher the protection value of a mask, the longer the filtering performance. Effective duration can change depending on User health condition, respiration, moisture, speech style.