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:
- Medical face masks
- Personal face masks
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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.
Medical face masks must comply with requirements defined in EN 14683:2019 as follow |
TEST OF BREATHABILITY (air permeability)
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TEST OF BIOCOMPATIBILITY – CYTOTOXICITY (1) |
TEST OF BACTERIAL FILTRATION EFFICIENCY – BFE |
TEST OF MICROBIAL CLEANLINESS (BIOBURDEN) (2) |
TEST OF SPLASH RESISTANCE (resistance against liquids) (3) |
For personal face mask we recommend the following tests
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TEST OF BREATHABILITY (air permeability) |
TEST OF BIOCOMPATIBILITY – CYTOTOXICITY (1) |
TEST OF BACTERIAL FILTRATION EFFICIENCY or VIRAL FILTRATION EFFICIENCY – BFE or VFE (4) |
(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
In brief: Testing of medical face masks in accordance with EN 14683:2019
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.
- TEST OF
BIOCOMPATIBILITY – CYTOTOXICITY
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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.
- TEST OF
BACTERIAL FILTRATION EFFICIENCY
(BFE) or VIRAL EFFICIENCY (VFE)
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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.
- TEST OF MICROBIAL CLEANLINESS (BIOBURDEN)
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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.
- TEST OF SPLASH
RESISTANCE
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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.
- RISK
ASSESSMENT (FOR REUSABLE MASKS)
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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).