VFE Certification

The aim of CSMED medical face masks is, further to compliancy with the applicable norms, the assurance of meaningful protection against SARS-CoV-2. In cooperation with Nelson Laboratories LLC, we conducted focused Viral Filtration Efficiency (VFE) study and tests that assure effective protection against the SARS-CoV-2 particles.

TESTING ACCORDING TO EN 14683:2019

BACTERIAL
FILTRATION EFFICIENCY (BFE)

According to Regulation (EU) 2017/745 Medical Face Masks are tested according to EN 14683:2019+AC for their Bacterial Filtration Efficiency and according to their performance (and additional criteria) are classified to types I, II, and IIR.

The bacterial particles of the BFE test have an approximate size of 1μm, whereas the size of SARS-CoV-2 viral particles is 0.1μm. In other words, SARS-CoV-2 viral particles are 10 times smaller in comparison with the bacterial particles used to test medical face masks.

CSMED medical face masks are classified to types II and IIR with BFE ≥ 99.9%, according to laboratory tests of EU accredited bodies.

TESTING AGAINST VIRAL PARTICLES

VIRAL
FILTRATION EFFICIENCY (VFE)

Nelson Laboratories conduct the focused Viral Filtration Efficiency (VFE) test, which evaluates protection from a wide range of viruses with diameter 0,025 μm i.e., viruses with diameter even 4 times smaller compared to SARS-CoV-2.

The test is made under the STP 0007 Rev 16 procedure and the US FDA 21CFR directive and responds to the needs for reliable protection against SARS-CoV-2.

Nelson labs’ studies and test report for CSMED medical face masks prove filtration efficiency of viral particles up to 4 sizes smaller compared to SARS-CoV-2, 99.20% or higher.