What is EN 14476?
EN 14476 is a quantitative suspension test for the evaluation of virucidal activity in the medical area. Products which are tested against this European test standard are proven to be effective against all enveloped viruses including Coronaviruses and SARs-CoV2.
How is the test conducted?
The virucidal efficacy test is set up with three concentrations of test product solution and a 5‐minute contact time. Virus is exposed to disinfectant in 24‐well plates, then neutralised, serially diluted and virus titred in 96‐well tissue culture plates to determine the tissue culture infectious dose50 (TCID50) of surviving virus. Vaccinia virus VR‐1549 Elstree strain / Vero cells are assayed in parallel in each test.
- Cytotoxicity control: The test product solution is measured for its effects on the host cells used to propagate the virus, to determine the
sensitivity of the assay.
- Interference control: The effect of the cells after treatment of the test product solution are verified to ensure the cells can show
susceptibility for virus infection. This is compared against cells that have not been treated with test product.
- Disinfectant suppression control VS1: Virus is added to the highest concentration of test product solution and then the mixture immediately removed
and neutralised. The neutralised virus titre is then determined to assess the efficiency of the neutralisation
- Disinfectant suppression control VS2: Internal control which adds virus to neutralised test product solution to assess the efficiency of the neutralisation
- No column Control: Internal control on the highest contact time to assess any impact of the Microspin™ S 400 HR columns.
- Virus recovery control: Virus titre is determined for virus in contact with sterile distilled water at t=0, t = 5 and at t =15. The virus titre after 5 minutes is then compared to the recovery of disinfectant‐treated virus to measure the log reduction in virus titre. The virus titre at 15 minutes is compared to the reference virus inactivation control.
- Reference virus inactivation control: Virus is exposed to 0.7% W/V formaldehyde and the recovery of virus determined by TCID50 after 5 and 15 minutes,
in order to assess that the test virus has retained reproducible biocide resistance. In addition, the formaldehyde cytotoxicity of neutralised formaldehyde is determined, to measure assay sensitivity.
Products tested according to EN 14476 are effective against all enveloped viruses as listed below. This therefore includes all Coronaviruses and SARS‐CoV‐2.
Products which have been tested according to EN 14476 with efficacy of 30 seconds:
- Zappy Isopropyl Alcohol Wipes
- Zappy Ultimate Antiseptic Wipes
- HospiCare 70% Isopropyl Alcohol Wipes
- HospiCare 3525 Alcohol Wipes
- HospiCare Waterbased Disinfectant Wipes