Face masks testings

LOTRIČ Metrology Ltd in collaboration with partner National Institute of Biology (NIB), perform face mask tests in accordance with EN 14683:2019. In addition to the produced masks, we are also testing materials intended for the manufacture of masks in the development phase.

The face masks on which we perform tests are divide into two groups:

These tests have a key role in conformity assessment of face masks. Based on these tests’ contracting authority obtains test certificates, based on which it can determine the conformity of the face masks with the standard EN 14683:2019.

Test results are important because they show a lot about material characteristics (permeability, filtration efficiency, biocompatibility or cytotoxicity, etc.). It is therefore easy to decide which material is suitable for the manufacture of personal masks, from a safety and health standpoint.

(1) A comprehensive risk assessment in accordance with ISO 10993-1:2009 is required.

(2) Only for sterile packaged medical face masks.

(3) Only for type IIR medical face masks.

(4) The manufacturer may decide for one or both tests.

For reusable mask, evaluation and testing within a risk management process is essential. If necessary, the tests shall be repeated according to the process prescribed for re-use of the products.

Location of testing laboratory and delivery address:

LOTRIČ Metrology Ltd.

Selca 163

4227 Selca

Slovenia, EU

The test shall be carried out in accordance with the requirements of EN 14683:2019 in order to determine the respiratory capacity of the person wearing the mask. The test determines the pressure drop at a constant flowrate through the body of the mask. Before that, the mask is conditioned at certain temperature and relative humidity, like that created by wearing the mask and breathing.

The test shall be carried out in accordance with the requirements of EN 14683:2019 and is prescribed as risk assessment in accordance with ISO 10993:2009 in order to analysing mask materials for the health of the person wearing the mask. The test determines the viability of model cell culture (cytotoxicity), which is exposed to the leaching of the material from which the mask is made. In this way, similarly to later skin contact, conditions are created like the wearing of a mask.

The test shall be carried out in accordance with the requirements of EN 14683:2019 in order to determine the mask filtration efficiency to the bacteria. The test determines the effectiveness of stopping the bacteria from passing through the body of the mask at a constant flowrate and loading the air with a certain number of bacteria. All bacteria passing the mask are captured and the colonies are counted after incubation. The bacterial filtration efficiency is calculated and expressed as a percentage. A similar but adopted test can be performed with model viruses (bacteriophages) that are slightly smaller than the SARS-CoV-2 virus instead of bacteria.

        The test shall be carried out in accordance with the requirements of EN 14683:2019 and is prescribed in accordance with ISO 11737-1:2018 in order to analyse the burden of the mask with microorganisms which may present a health hazard to the person wearing the mask. The word microbial cleanliness defines the absence of a population of living microorganisms on a product. The test determines the number of microorganisms present and is performed only for medical face masks that are sterile packaged.  

The test shall be carried out in accordance with the requirements of EN 14683:2019 and is prescribed in accordance with ISO 22609:2004 in order to determine the resistance to the splash which may present a health hazard to the person wearing the mask. The test is performed only for medical face masks type IIR, and normally used in surgery. The test simulates a splash of artificial blood on the mask at a similar pressure and volume as it occurs in the ruptured vein of a person.

A risk assessment shall be carried out in accordance with ISO 14971:2019 in order to analyse the risks of reuse of the mask, insofar as the process of preparing the mask before the next use can alter the results of the tests described above, which may pose a health risk to the person wearing the mask. If there are risks, one or more tests described above shall be repeated after a certain number of mask preparation before the next use as prescribed by the manufacturer (washing, disinfection, sterilisation or other form of preparation).