The need for effective viral infection prevention and control has increased post-COVID-19 pandemic. One effective method of infection control includes the use of disinfectants with virucidal activity. However, these disinfectant products must be released in the market only after being tested for their efficacy against viruses. One such standard that is internationally accepted to test their virucidal efficacy is EN 14476. This article gives a brief introduction to EN 14476, the importance EN 14476 testing for disinfectants, the test procedure, and its practical applications.
EN 14476 standard
EN 14476 is a quantitative suspension test which is used to assess the virucidal activity of disinfectants used in medical areas. The test ensures that the disinfected products tested meet the required level of efficacy against viruses under specified conditions.
The importance of virucidal testing
The importance of virucidal testing cannot be overstated. It is important for protecting public health, especially in healthcare settings where the risk of spread of viral infections is too high. Disinfectant products that pass the EN 14476 test contribute to infection prevention and control measures by effectively inactivating viruses.
Scope
A wide range of disinfectants used in various medical applications can be tested for their virucidal efficacy using the EN 14476 test method. These products include hand hygiene, surface disinfection, and instrument disinfection. Test conditions such as contact time, temperature, and the presence of interfering substances are maintained during the testing procedure to mimic practical conditions.
Key Components of EN 14476 Testing
Test Organisms
As per this standard, both enveloped viruses like vaccinia virus and non-enveloped viruses such as poliovirus can be used for testing the virucidal activity of disinfectants.
Test Conditions
EN 14476 outlines minimum test conditions, including:
- Contact Time: varies between 30 seconds to 60 minutes
- Temperature: 20℃
- Interfering Substances: Organic and inorganic substances that may affect the efficacy of the disinfectant are added to simulate dirty and clean conditions.
Test methodology
Titrating the virus
Methods such as TCID50 (Tissue Culture Infectious Dose 50) or plaque assays are used to determine the infectivity titer. These methods quantify the amount of virus present before and after treatment with the disinfectant.
Assessing cytotoxicity of disinfectants
Cytotoxicity control studies of the disinfectants need to be performed to ensure that the disinfectant solution does not cause cell damage. It is determined by testing the product test solution on cell cultures to observe for cytotoxic effects.
Validating test method
The EN 14476 test method is validated by verifying that the experimental conditions are consistent and reproducible. This includes checking the efficiency of virus inactivation and the accuracy of the results.
Interpreting the results
The virucidal activity of a disinfectant is expressed as the log reduction in virus titer. A product is considered effective if it achieves a significant reduction in viral infectivity, typically a 4-log (99.99%) reduction for both enveloped viruses as well as non-enveloped viruses.
Practical Applications
Surface Disinfection
EN 14476 tested disinfectant products are used for the surface disinfection in healthcare facilities. These products ensure effective surface disinfection thus preventing the spread of viral infections through high-touch surfaces.
Hand Hygiene
Hand hygiene products including hand sanitizers and handwashes used in medical and community settings must be tested using EN 14476 to ensure that they perform effectively.
Instrument Sterilization
Medical instruments which come in contact with blood, mucous membranes or other bodily fluids and tissues must be disinfected with products that are EN 14476 certified. This ensures that the instruments are free from any possible contaminations or the presence of viable viruses that could potentially cause infections.
The impacts of EN 14476 on manufacturers and healthcare providers
Manufacturers
EN 14476 compliance is important for manufacturers of disinfectants and antiseptics to ensure that they gain market access in Europe. Products that pass the EN 14476 test can be labeled as effective against viruses which provides manufacturers with a competitive edge in the market.
Healthcare Providers
Healthcare providers tend to trust products that meet EN 14476 standards to ensure effective infection control. The use of tested and certified virucidal disinfectant products helps reduce the risk of viral infections thus protecting both patients and healthcare workers.
Role of MIS
At Microbe Investigations Switzerland, we specialize in EN 14476 testing to verify the efficacy of disinfectants in preventing and controlling viral infections. Our expert microbiologists employ advanced testing methodologies to deliver precise and reliable results, ensuring your disinfectants meet stringent international standards for virucidal activity. Trust MIS to help you maintain high standards of infection control and enhance the safety of your products.
To learn more about our EN 14476 testing services or to schedule a consultation, please contact our specialists today.
