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EN 14476 Test
Quantitative suspension test for the evaluation of virucidal activity of disinfectants used in the medical area
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Summary
EN 14476 testing evaluates the virucidal activity of chemical disinfectants using a quantitative suspension method. It confirms whether a product achieves the required level of virus inactivation defined by the standard. Our lab provides precise log-reduction data, fast turnaround times, and test reports that support compliance needs and product claims prior to market launch.
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Quick understanding about test
EN 14476 Test - Quantitative suspension test for the evaluation of virucidal activity of disinfectants used in the medical area
EN 14476 is a phase 2, step 1 suspension test used to assess the virucidal activity of disinfectants and antiseptics intended for medical areas.
- Non-enveloped viruses: Poliovirus, Adenovirus, Murine Norovirus (Parvovirus for high temperatures).
- Enveloped viruses: Vaccinia virus.
- The disinfectant is inoculated with test viruses and incubated under specified conditions. After the contact time, the virucidal action is stopped, and viral infectivity is measured using the TCID50 assay.
- Ensures patient safety by reducing healthcare-associated infections.
- Enhances regulatory compliance and market credibility.
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What Is EN 14476?
EN 14476 is phase 2 step 1 suspension test employed to assess the virucidal efficacy of disinfectants used in the medical areas. It provides a quantitative assessment to ensure that products effectively inactivate viruses, meeting the high safety requirements necessary for both the European market and hospital-grade applications.
What Does EN 14476 Test For?
The standard applies to products intended for use in the medical field, including but not limited to:
- Hygienic hand rubs and hand washes
- Instrument disinfectants
- Surface disinfectants
- Textile disinfectants
- Disinfectants used in patient care, nursing homes, clinics of schools, and kindergartens
EN 14476 Update : What’s Likely to Change in the 2024 Draft?
The draft EN 14476:2024 introduces several updates.
- It now includes peracetic acid as a reference substance.
- Handwash claims are segregated in a separate section with virucidal activity tested with enveloped virus (Vaccinia virus) and the log reduction requirements have been adjusted to 2 log for handwash products and 4 log for others.
- Virucidal activity against enveloped viruses has been added for instrument and textile disinfection.
- The Large Volume Plating (LVP) method and calculations have been moved from the annex into the main text and harmonized with EN 13727.
- Cell line references have been clarified, noting that listed numbers are only examples. Importantly, previous test results remain valid, except for cases using gel filtration detoxification without parallel titration.
It is to note that prEN 14476:2024 is currently under CEN enquiry (review stage) and has not yet been officially published.
Test conditions and requirements for EN 14476 test method
Efficacy Criteria: Products must demonstrate at least 4 log reductions in virus titers to pass the test, ensuring they perform effectively under practical conditions.
The virucidal activity shall be tested using non-enveloped and enveloped viruses.
The contact times for surface disinfectant products applicable for health care facilities should be maximum of 5 minutes. The area of disinfection may include patient’s care area, medical staff, equipment, floors, and other surface areas. Whereas, products other than those mentioned above may be tested with a contact time of a maximum of 60 minutes.
EN 14476 Test Method We Follow
- To prepare a test suspension, a sample product is either diluted or directly added (ready-to-use product) to an interfering substance.
- In the next step, the virus is inoculated into test suspension.
- The incubation period and temperature are maintained as per the manufacturer’s requirement and assay is performed under clean and dirty conditions depending on the test product.
- At the end of the contact time, an aliquot (small portion) of the sample is taken immediately and its virucidal action is suppressed by an ice cold maintenance medium.
- Serial dilutions of the virus are transferred onto monolayer cell culture using 96 well plates and viral infectivity is measured by using TCID50 assay.
- After incubation, cells are examined for CPE (cytopathic effect).
- Reduction of virus infectivity is measured from the differences of virus titer with control (without test product) and after the treatment with test product.
Control Tests
Control tests are run to ensure that observed reduction in viral infectivity is truly due to the disinfectant being tested, and not due to other variables. The 4 control tests are:
Virus control
Assesses the infectivity of the test virus suspension. For the test to be valid, the virus load in the control must be sufficient to enable a 4-log reduction.
Cytotoxicity control
This test checks if the disinfectant itself harms the cell structure, ensuring that any virus reduction is due to its antiviral action and not cell damage.To pass the test, live cells should not show toxic reaction or damage to a point where the achievement of 4-log reduction becomes impossible.
Suppression control
It verifies that the neutralization process successfully stops the virucidal action of the test product after the set exposure time.
Interference control
The purpose is to ensure that the susceptibility of the cells to the virus infection is not negatively affected by the test sample
EN 14476 vs Other standards
| Category | EN 14476 | EN 16777 | EN 17122 |
| Claims | Antiviral | Antiviral | Antiviral |
| Mandatory test organisms | Enveloped & non-enveloped viruses such as Poliovirus, Adenovirus, Murine Norovirus, Vaccinia virus (representative panel) | Adenovirus and Murine Norovirus for general virucidal claims; Vaccinia virus for enveloped virus claims | Murine Norovirus |
| Scope of products | Disinfectants, antiseptics, hand hygiene products, and textile disinfectants for medical/healthcare applications | Disinfectants intended for non-porous surface disinfection in medical areas without mechanical action | Medical gloves used in healthcare and medical settings |
| Passing criteria (Log reduction / evaluation) | ≥ 4 log reduction | ≥ 4 log reduction | ≥ 4 log reduction |
How MIS can help you with disinfectant efficacy testing services ?
If you are interested in ensuring that your disinfectants meet the highest standards of virucidal efficacy, contact Microbe Investigation Switzerland today. Our expert team is ready to provide comprehensive testing and validation services tailored to your needs. Ensure the safety and effectiveness of your products by trusting MIS for all your microbiology testing requirements.
Request EN 14476 Testing
Need to validate virucidal efficacy of your disinfectant in accordance with EN 14476? Contact us today to schedule testing and obtain reliable, standards-compliant results.
Frequently Asked Questions
DR. Martinoz Scholtz
Yes, compliance with EN 14476 is recognized globally and can aid in acquiring approvals in various countries due to its stringent testing requirements.
Typically, the test takes 2 to 4 weeks to complete, depending on the number of viruses tested.
Products such as hygienic hand rubs, hand washes, textile disinfectants, surface disinfectants, and instrument disinfectants can be tested with EN 14476.
The key differences between EN 14476 and other assays for viral efficacy are mainly associated with specific protocols, viruses tested, and applied performance criteria. Other assays from organizations like the in US EPA will have different requirements and test methods. Apart from that, specific conditions of the tests and log reduction criteria under EN 14476 are different from those other standards, thus making this assay a unique antiviral efficacy assessment tool.
This standard is a European test method that evaluates the virucidal activity of chemical disinfectants. In comparison, US regulations, such as those enforced by both EPA and FDA, include similar efficacy testing that would apply different methods and possibly different viruses for testing. In either case, the goal is to ensure that a product will be effective against viral pathogens, although regulatory requirements and accepted test protocols differ
The results obtained from this test will be useful in highlighting the strengths and weaknesses of your products. This information can be used to enhance your formulation to improve the efficacy of the product. Also, conducting these tests ensures compliance with regulatory standards.
This test validates the hand sanitizers by measuring the reduction in viral load on the skin or another surface. The test involves contaminating the surface or skin with a virus, applying the sanitizer, and then determining the reduction in viral infectivity. A product exhibiting at least 4 log reduction in viral activity as per the requirements of the standard is considered to be effective.
For a full virucidal activity claim the EN 14476 suspension test is typically performed against the following mandatory test viruses:
- Poliovirus type 1 (very resistant, non-enveloped)
- Adenovirus type 5 (non-enveloped)
- Murine norovirus or similar norovirus surrogate (non-enveloped)
Passing against all three supports a broad (full) virucidal claim.
Contact times in EN 14476 vary based on product type and intended application. Typical ranges include:
- Hygienic handrubs/handwashes: 30–120 seconds
- Instrument disinfectants: up to 60 minutes
- Surface disinfectants: 5 – 60 minutes
- Textile disinfectants: up to 20 minutes
A ≥4-log reduction means a 99.99% reduction in infectious virus.
Common interfering substances include bovine serum albumin (BSA) for clean conditions. For dirty conditions, higher BSA levels and sheep erythrocytes are used.
Testing is performed at specified temperatures relevant to the product’s intended use. Temperature influences viral inactivation efficiency. It must be controlled and documented during testing.
Neutralisation stops the disinfectant’s action after the contact time. This is done using validated chemical neutralisers or dilution methods. Neutralisation controls confirm accuracy of results.
Yes. EN 14476 covers both virus types depending on the claim. Non-enveloped viruses are required for full virucidal activity, while enveloped viruses support limited virucidal claims.
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