We carry out accredited tests of medical masks in accordance with EN 14683.
The scope of the accredited tests covers the whole of EN 14683:2019, with the exception of clause 5.2.6 (Biocompatibility – cytotoxicity), which is carried out by the partner National Institute of Biology (NIB):
LOTRIČ Metrology is accredited by Slovenian Accreditation with accreditation number LP-099 in the field of testing (ISO/IEC 17025).
The test shall be carried out in accordance with the requirements of EN 14683 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 and is prescribed as risk assessment in accordance with ISO 10993 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 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 and is prescribed in accordance with ISO 11737-1 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.
The test shall be carried out in accordance with the requirements of EN 14683 and is prescribed in accordance with ISO 22609 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 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).
Combustibility test on a medical mask
Splash resistance test
Breathing resistance test
Testing medical masks in the safety cabinet
Mask testing laboratory
Testing face masks
We are one of only 5 laboratories in the EU which can offer such a wide range of services.
All tests are performed in brand new laboratories equipped with modern testing equipment.
The reason we have such a great case study here
is that we are professional and flexible.
And we are able to deliver results
in a very short period of time.
About the integrity of an individual
who has signed the papers.
To either sell or buy or use
a piece of standardized equipment
such as the face masks.
We can offer manufacturers a comprehensive service in the field of certification of protective masks.
Certification body LOTRIČ Metrology, by enrolling in the NANDO database at the European Commission, we became Notified Body NB 2897 for respiratory protective devices – filtering half masks to protect against particles (EN 149), in accordance with the Regulation (EU) 2016/425 on personal protective equipment.
Choosing the right mask is a daunting task.
For the purpose of expert review of the documentation of medical or protective masks, we in LOTRIČ Metrology prepare a Technical Report with detailed descriptions of all established facts.
We carry out accredited tests:
After performing the calibration, testing, control and qualification procedures in the LOTRIČ Metrology Group, you will receive an approved certificate, which clearly states all the parameters that are important to your clients and enables you to prove and guarantee your quality.
We are recognised as a reference partner that has been working in the field of calibrations, testing, inspection and qualifications for decades. Simultaneously with the development of services, we also developed a certificate based on the wishes, needs and in-depth cooperation of our partners.
To review the instructions, we would like to thank doc. dr. Mateja Logar, Ph.D. med., specialist infectologist, Clinic for Infectious Diseases and Febrile Conditions, SPOBO, University Medical Center Ljubljana.
With the obtained certificate, you prove the safety of laboratory equipment for people and products.
A professional, impartial and independent procedure determines compliance to ensure security.
LOTRIČ Metrology certificate as proof of the quality and longevity of your product.
