The latest revision of EN 14476, the Phase 2, Step 1 suspension test for evaluating virucidal activity of disinfectants in the medical area was officially published on October 1st. This new revision replaces the EN 14476:2013+A2:2019 version and takes effect immediately. Since the last amendment, the CEN members with the collective effort of experts in the infection control field have gained significant insights through multiple studies and ring trials which have been incorporated into a new, more harmonized and refined standard method, ensuring greater consistency and reliability in standard virucidal testing.
“What happens to the tests we had just done with the previous EN 14476 standard? Do I need to retest my products?” – How does EN 14476:2025 differ from the old version? Will these changes affect your product claims? Here is all you need to know about the new EN 14476:2025 standard.
What’s new in EN 14476:2025?
In this blog, we will focus solely on the changes affecting testing conditions and product claims that manufacturers and end users should be aware of, and less on the changes relating to the technical test procedure implementation by laboratories.
| PRODUCT TYPE | WHAT CHANGED? | WHY IT MATTERS? |
| Hygienic handrub | Test temperature for alcohol-based products against adenovirus to be tested at 25°C only. | Studies have shown that adenovirus is more resistant towards alcohol at lower temperatures1. Temperature of human hands are closer to 25°C compared to 20°C in the previous standard. This change in obligatory test temperature prevents false-negative results when tested against adenovirus, allowing products to pass the test easier. |
| Hygienic handwash | Passing criteria set at 2 log reduction upon testing at 50% concentration as ready-to-use product. | Harmonizes virucidal evaluation with other European Standards such as EN 13727 and EN 13624 which sets the passing criteria of handwash products 2 log below the standard passing criteria. |
| Instrument disinfection | Virucidal activity against enveloped viruses spectrum added with vaccinia virus as the obligatory strain. | In the previous version, this spectrum was only listed for hand and surface disinfection, but is still generally accepted by regulators in various regions for other product types. This new adaptation now officially allows such claim to be made according to the standard method. |
| Textile disinfection |
There are no changes to the obligatory strains for each spectrum of activity.
Besides that, the addition of glutaraldehyde as the reference chemical in the inactivation test is also an important inclusion in ensuring consistency of results between different laboratories. Viruses or microorganisms in general are living organisms beyond our control that may grow into varying resistance level. Therefore, running the reference inactivation test with additional fixed references allows us to check that the resistance of viruses is as expected and not reduced or increased leading to false-positive or false-negative results. At TECOLAB, we always verify the viruses we use with reference products, ensuring they fall within the acceptable criteria for valid testing.
Do you need to retest?
Good news! The answer is no. The changes of this new revision have no impact on the test results therefore the results from EN 14476:2013+A2:2019 are still valid with the exception of tests using gel filtration detoxification. Therefore, it is most likely a majority of products will not need retesting.
If you would like advice on whether the new EN 14476 revision affects your disinfectant claims, our experts here at TECOLAB are always available to help you navigate compliance with the latest standard, from reviewing your current reports to advising on future test planning. Drop us an email and leave the rest to us!
References:
1. Ruhlandt, Marina, et al. “Impact of concentration, temperature and pH on the virucidal activity of alcohols against human adenovirus.” American Journal of Infection Control 51.9 (2023): 1011-1016.