EN 14476: 2013 + A2: 2019. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (phase 2, step 1).
Test accredited by ENAC (Spanish National Accreditation Entity), for standard mandatory viruses and additionals.
The new trial version 2013 + A2: 2019 has increased the number of viruses from two to three. The mandatory viruses and test conditions are: 1) Handrub treatment and hygienic handwashing (Poliovirus, Adenovirus and murine Norovirus or Adenovirus and murine Norovirus only when a limited spectrum -envelopped viruses- is desired; test temperature of 20ºC, contact time between 30 and 120 seconds *; and clean conditions for handrub treatment and dirty conditions for hygienic handwashing); 2) Disinfection of instruments (Poliovirus, Adenovirus and murine Norovirus, or only Parvovirus when the disinfection temperature is 40ºC or higher *; test temperature between 20 and 70ºC *; contact time not exceeding 60 min *; clean or dirty conditions *); 3) Surface disinfection (Poliovirus, Adenovirus and murine Norovirus; test temperature between 4 and 30ºC *; contact time of 5 minutes maximum when close to patients surfaces or 60 minutes maximum for other surfaces *; clean or dirty condition *) ; 4) Disinfection of textiles (Parvovirus; test temperature between 30 and 70ºC *; contact time not exceeding 20 min *; dirty conditions). The product should be tested at least at three concentrations including one in the non-active interval and another in the active interval. To consider the product virucidal must demonstrate a 4 log reduction in infectivity. (*: The applicant of the test must choose within the ranges or alternative indicated). Important note: the products can be tested at a concentration equal to or less than 80%. Products ready for use can be tested at 97% if not pass the procedure at 80%. Products for handwashing, its maximum concentration in the assay is 50%.