EN 16777 is a phase 2 step 2 specifying the requirements for the activity of disinfectant products to be used in the medical area. These products should be for use on non-porous surfaces and without the use of mechanical action. This can include products used for disinfecting non-porous medical device surfaces.
A sterile stainless steel disc is inoculated with a suspension of virus and interfering substances and dried. The product is applied to this dried film and maintained at a specified temperature for a specified contact time. The virucidal action is then immediately suppressed and the remaining viable virus is quantified. Efficacy against vaccinia virus can be used for an enveloped virus claim and the full or limited spectrum virucidal activity claim can be achieved with adenovirus and murine norovirus (dependent on the results of the EN 14476 test). This test can be adapted outside of the standard to include other viruses, temperatures and contact times.
- Required organisms: Adenovirus, murine norovirus and vaccinia (enveloped viruses only). Other viruses are available on request
- Contact time: according to manufacturer’s instructions, not longer than 5 minutes or 60 minutes, depending on product type.
- Test temperature: between 18°C and 25°C
- End point: TCID50
- Efficacy: ≥ 4 Log reduction
