EN 14476: 2025. 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).
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The EN 14476: 2025 standard includes the possibility of using the following viruses depending on the purpose of the test: Poliovirus, Adenovirus, Murine Norovirus, Vaccinia virus and Murine Parvovirus. The mandatory viruses required according to the intended application of the product and the mandatory conditions of the test are the following: 1) Hygienic handrub: Poliovirus, Adenovirus and Murine Norovirus must be used for the general virucidal activity; only Adenovirus and Murine Norovirus when a limited spectrum against enveloped viruses and against certain viruses specified by the standard (Norovirus, Adenovirus and Rotavirus); and only with Vaccinia virus when activity against enveloped viruses is desired*; test temperature of 20ºC (25ºC for Adenovirus); time of contact between 30 and 120 seconds*; and at least under clean conditions*; 2) Hygienic handwashing: only with Vaccinia virus for activity against enveloped viruses; assay temperature of 20ºC; time of contact between 30 and 120 seconds*; and at least under dirty conditions*;3) Instruments disinfection: Poliovirus, Adenovirus and Murine Norovirus must be used, or only Murine Parvovirus when temperature for disinfection is 40ºC or higher; and only with Vaccinia virus when activity against enveloped viruses is desired for pre-cleaning products (with a combined cleaner/disinfectant) (<40ºC)*; assay temperature between 20 and 70ºC* (≥40ºC only Parvovirus); time of contact not longer than 60 min; and under clean or dirty conditions*; 4) Surface disinfection: Poliovirus, Adenovirus and Murine Norovirus must be used for the general virucidal activity; only Adenovirus and Murine Norovirus when a limited spectrum against enveloped viruses and against certain viruses specified by the standard (Norovirus, Adenovirus and Rotavirus); and only with Vaccinia virus when activity against enveloped viruses is desired*; assay temperature between 4 and 30ºC*; time of contact no longer than 60 minutes*; and under clean or dirty conditions*; 5) Textile disinfection: Murine Parvovirus for virucidal activity or Vaccinia virus when activity against enveloped viruses is desired*(<40ºC); assay temperature between 30 and 70ºC*(< 40ºC for Vaccinia virus); time of contact between 10 and 20 min*, and under clean (for pre-washed process) or dirty conditions (for non-pre-washed process).
The standard leaves open the possibility of using any other relevant virus and conditions for any of the product's applications. 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 (these two last concentrations are selected by the testing laboratory). To consider the product as active a 4 logarithmic reduction in the infectivity of test viruses must be obtained. For hygienic handwash products, a 2 logarithmic reduction in the infectivity of Vaccinia virus must be obtained. The standard recommends conducting two tests on different days to calculate the average and improve the accuracy of the test results.
(*: the client must choose among the alternatives conditions and indicate the selected conditions in the test submission form).
Summary table of the minimum test conditions indicated by the EN 14476 standard
|
Test conditions |
Hygienic handrub |
Hygienic handwash |
Instrument disinfection |
Surface disinfection |
Textile disinfection |
|
Minimum test viruses |
Virucidal activity: Poliovirus, Adenovirus and Norovirus Limited spectrum virucidal activity: Adenovirus and Norovirus Activity against enveloped viruses: Vaccinia virus |
Activity against enveloped viruses: Vaccinia virus |
Virucidal activity: Poliovirus, Adenovirus and Norovirus Virucidal activity for temperatures ≥40ºC: Parvovirus Activity against enveloped viruses for pre-cleaning products(<40ºC): Vaccinia virus |
Virucidal activity: Poliovirus, Adenovirus and Norovirus Limited spectrum virucidal activity: Adenovirus and Norovirus Activity against enveloped viruses: Vaccinia virus |
Virucidal activity: Parvovirus
Activity against enveloped viruses (<40ºC): Vaccinia virus |
|
Test temperature |
20ºC (25ºC for Adenovirus) |
20ºC |
20-70ºC |
4-30ºC |
30-70ºC |
|
Contact time |
Between 30 and 120 seconds |
Between 30 and 120 seconds |
≤ 60 minutes |
≤ 60 minutes |
10-20 minutes |
|
Soiling |
Clean |
Dirty |
Clean or dirty |
Clean or dirty |
Clean (for pre-washed process) or dirty (for non-pre-washed process) |