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EN 14476 Test
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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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Abstract
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.
Scope and application
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
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 procedure
- Preparation: A sample product is diluted or directly added to an interfering substance.
- Inoculation: The virus is inoculated into the test suspension.
- Incubation: The mixture is incubated at specified conditions.
- Inactivation: After the contact time, the virucidal action is stopped by an ice-cold maintenance medium.
- Titration: Serial dilutions of the residual virus are performed and inoculated on cell lines to measure viral infectivity using the TCID50 assay.
- Calculation: Reduction of virus titer under the effect of the disinfectant is calculated.
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
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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.
Products such as hygienic hand rubs, hand washes, textile disinfectants, surface disinfectants, and instrument disinfectants can be tested with EN 14476.
Typically, the test takes 2 to 4 weeks to complete, depending on the number of viruses tested.
As per this standard, a limited spectrum test is performed with Adenovirus and Murine norovirus. A full spectrum test includes the Poliovirus in addition to the limited spectrum viruses. For testing against enveloped viruses, the use of Vaccinia virus is recommended. This standard also allows for testing with a virus of the product manufacturer’s choice like SARS CoV-2, Beta Coronavirus (OC-43), Human Coronavirus (229E), Influenza A (H1N1) or Influenza A (H3N2), etc.
Strict safety measures include the use of biosafety cabinets and PPE, proper disposal of biohazard waste, and adherence to GLP guidelines.
Common challenges faced during this test include maintaining a consistent virus titer for comparative studies, avoiding any risk of contamination between the samples, maintaining the stability of the virus during the testing process, and accurately measuring the reduction of viral activity. In addition, differences in product formulations create variabilities in outcomes therefore, care must be taken during preparation and standardization.
The results of this test can significantly improve the marketability of your product based on the proof of antiviral effectiveness. This certification guarantees users and regulatory authorities that the product meets high European standards for disinfectants, thereby differentiating the product from competitors and boosting consumer confidence.
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. In this test, the test virus and the surface contaminated with it are treated with a sanitizer, and the reduction in viral infectivity is determined. A product exhibiting at least 4 log reduction in viral activity as per the requirements of the standard is considered to be effective.
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 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 in other standards, thus making this assay a unique antiviral efficacy assessment tool.
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