Face mask tests according to EN 14683 for type II and type IIR masks

We offer comprehensive test packages for verifying the quality of type II and type IIR face masks according to the EN 14683 standard. The tests included in the packages are required to label face masks with the CE marking.

Medical face masks are divided into Types I and II according to their bacterial filtration efficiency. Type I masks are not intended for healthcare professionals, but for the public to prevent the spread of infectious diseases. Type II masks are further classified based on whether they are splash-resistant (Type IIR) or not (Type II).

To comply with the European Standard EN 14683, Type II face masks must undergo the following quality tests:

• Bacterial filtration efficiency (BFE) - The ability of the face mask to filter the bacterium Staphylococcus aureus. The BFE is expressed as the percentage of colony-forming units (cfu) that have passed via aerosol through the facemask. If a face mask consists of two or more areas with different characteristics, these areas will be tested separately.

• Breathability (Differential pressure) - The amount of differential pressure required to draw air through a measured surface area at a constant flow rate.

• Microbial cleanliness (Bioburden) - The measurement of colony forming units per gram as per EN ISO 11737-1.

• Biocompatibility - The medical face mask manufacturer shall complete a biocompatibility evaluation according to ISO 10993-1 as a surface device with limited contact. The applicable toxicology testing regimen shall also be determined.

In addition to the above, Type IIR masks require the following test:

• Splash resistance - Performed according to ISO 22609, this test determines the ability of a face mask to resist penetration of splashes of liquid at different pressures.

The lower displayed price applies to the Type II mask test package, while the higher price also includes the splash resistance test required for Type IIR masks.