EN 14476-Virucidal activity test against Influenza A H1N1 virus, following the methods recommended by the standard UNE-EN 14476:2014 + A1:2015 for chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (phase 2, step 1).
Test assay accredited by ENAC (National Accreditation Entity).
Note: the EN 14476 guideline requires as mandatory to perform the assay the following three strains: Poliovirus type 1, Adenovirus type 5 and Murine Norovirus. This is due that these virus are more resistant to disinfectants action and when a disinfectant is active against them it is considered that it is active against other non-tested viruses. If the test is performed with other species/strains (e. gr. Influenza A H1N1 virus) it can be certified that the testes product shows activity against this species/strains of virus but it does not meet the requirement of the guideline to be considered virucidal in general.
UNE-EN 14476: 2014 + A1: 2015.
The new 2013/2014 version of the assay EN 14476, have Increased the number of viruses from two to three. The following mandatory viruses and conditions for the assay are summarized as: 1) Hygienic handwashing or hygienic handrub (Poliovirus, Adenovirus and Murine Norovirus or only Adenovirus and Murine Norovirus when a limited spectrum against enveloped viruses is desired, or alternatively only Vaccinia virus when activity against enveloped viruses is desired *; assay temperature of 20ºC, contact time of between 30 and 120 seconds *; and at least under clean conditions for hygienic handrub, or dirty conditions for hygienic handwashing *); 2) Instruments disinfection (Poliovirus, Adenovirus and Murine Norovirus, or only Parvovirus when temperature for disinfection is 40ºC or higher; assay temperature between 20 and 70 *; time of contact not higher of 60 min, and under clean or dirty conditions *); 3) Surface disinfection (Poliovirus, Adenovirus and Murine Norovirus; assay temperature beteen 4 and 30ºC *; time of contact of 5 min or 60 min *; and under clean or dirty conditions *); 4) Tissue or clothes disinfection (Parvovirus; assay temperature between 30 and 70ºC *; contact time not higher than 20 min *, and under dirty conditions). The product must be assayed at least at three concentrations, including one in the non-active concentration range and another in the active concentration range. To consider the product virucidal a 4 logarithmic reduction in the infectivity of viruses must be obtained (*: the customer must chose among the alternatives conditions, and Indicate in the test submission form).
Important: the products can be tested at a concentration equal or lower than 80%. The ready-to-use products can be tested at 97% concentration If they do not pass the test at 80%. The maximum concentration of test products for hygienic handwashing is 50%.