EN 14476 Quantitative Suspension Test for the Evaluation of Virucidal Activity of Chemical Disinfectants and Antiseptics in Human Medicine

Purpose of Test

The purpose of this test is to determine the minimum virucidal activity of a chemical disinfectant in contact with medical instruments, surfaces or hands, according to EN test methods developed by the CEN (European Committee for Standardization) to support registrations within Europe. The method described is intended to determine the activity of chemical disinfectants that form a homogeneous, physically stable preparation in hard water – or in the case of ready-to-use products – with deionized water, and in the conditions in which they are used.

Summary of Test

A suspension of virus is added to a solution of interfering substances; the interfering substance used is dependent on the product claim. The prepared test product is added to the suspension of virus in interfering substance and is maintained at the requested temperature for the requested exposure time(s). At the end of the exposure time, aliquots are taken and the virucidal activity against the test virus is immediately neutralized or suppressed by dilution in ice-cold test medium. Serial dilutions are performed and the dilutions are then assayed for viral infectivity by an assay method specific for the testing virus. Appropriate controls are performed in parallel with the assay. Reduction of virus infectivity is calculated from differences of log virus titers before and after treatment with the product.

Test Organisms Adenovirus, Poliovirus Bovine, Parvovirus, and additional pathogens
Purpose of Test Suspension-based study used as a presumptive test to evaluate virucidal activity.
Typical Performance Criteria
(Requirements may vary by claim)
4 log reduction