Our Certifications
U-Mask is a true technological revolution.
U-Mask Model 2.2 is a reusable filtering mask.
It is not classified as PPE (Personal Protective Equipment).
It is not certified as a MD (Medical Device).
Test
Test Goal
Test Method
Result
Bacterial Filtration Efficiency (BFE),
In → Out, (%)
A measurement of a mask material's resistance to penetration of bacteria, from the inside to the outside of the mask.
UNI EN 14683:2019
99,89 %
Breathability (Pa/cm^2)
Aimed at determining the air permeability of the mask.
UNI EN 14683:2019
57,8 Pa/cm^2
Bioburden (UCF/g)
An assessment of the absence of a population of viable microorganisms on the mask and / or packaging.
UNI EN 14683:2019
7,3 CFU/g
Splash test (kPa)
Detects the resistance of the mask to the penetration of blood splatters or synthetic liquids
UNI EN 14683:2019
Passed
Biocompatibility & Toxicological Report Biolayer
Check for the absence of negative or unwanted side effects generated by the materials used to build the mask (allergies, redness, irritation, toxicity, etc.).
ISO 10993-1:2018
Passed
Bacterial Filtration Efficiency (BFE),
Out → In, (%)
A measurement of a mask material's resistance to penetration of bacteria, from the outside to the inside of the mask.
UNI EN 14683:2019
99,88 %
Particle Filtration Efficiency (PFE) (%)
Evaluates the nonviable particle retention or filtration efficiency of masks, usually at sub-micron levels.
ASTM F2299 / F2299M
98.50 %
Antiviral Activity on Biolayer (Human Coronavirus 229E)
States the difference of the infectivity titer of the virus found on an antiviral-treated product compared to an untreated product after inoculation with and contact to the virus.
ISO 18184:2013
99.90%
Antibacterial Activity
on Biolayer
(Staphylococcus aureus and Klebsiella pneumoniae)
States the difference of the infectivity titer of bacteria found on an antibacterial-treated product compared to an untreated product after inoculation with and contact to bacteria.
ISO 20743:2013
99.995 % and 99.959 %
Antibacterial Activity after Aging on Biolayer (Staphylococcus Aureus and Klebsiella pneumoniae)
States the difference of the infectivity titer of bacteria found on an antibacterial-treated product compared to an untreated product after inoculation with and contact to bacteria, after materials are aged.
ISO 20743:2013
99.797 % and 99.861 %
Bacterial Filtration Efficiency (BFE),
In → Out, after 200 h
in-vivo (%)
A measurement of a mask material's resistance to penetration of bacteria, from the inside to the outside of the mask; performed on masks that have been used for 200 hours.
UNI EN 14683:2019
99,89 %
Breathability, after 200 hours in-vivo (Pa/cm^2)
It is aimed at determining the air permeability of the mask; performed on masks that have been used for 200 hours.
UNI EN 14683:2019
43.4 Pa/cm^2
Splash test after 200 hours in-vivo (kPa)
Detects the resistance of the mask to the penetration of blood splatters or synthetic liquids; performed on masks that have been used for 200 hours.
UNI EN 14683:2019
Passed
Acknowledgements
EU Seal of Excellence
Recognition obtained by the European Commission for the U-Mask Model Two project as part of the COVID-19 proposals.
