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EN 14476 Test
Quantitative suspension test for the evaluation of virucidal activity in the medical area
EN 14476 is used for the quantitative evaluation of the virucidal activity that performs the measurement of viral antimicrobial activity for sanitizers and disinfectants
EN 14476 is a quantitative suspension test used to evaluate whether the given disinfectant or antiseptics has the virucidal activity to control the spread of viral infection.
All the medical health facilities are a potential risk factor for spreading viral infections. In such situations, cleaning and disinfection become crucial to prevent the outbreak of diseases and even the spread of nosocomial infections (hospital-acquired infections). Chemical disinfectants and antiseptics that contain antiviral agents are preferably used in the healthcare sector for hygiene and sanitation.
Whereas, EN 1276 is used to evaluate the bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas.
Products that can be tested with EN 14476
- Hygienic handrub and handwash
- Instrument disinfection
- Surface disinfection
- Textile disinfection
- Disinfection in patient care, nursing home, and in clinics of schools and of kindergartens
EN 14476 Test Conditions
EN 14476 test method is used to determine the virucidal activity against both a limited and broad spectrum of test organisms. To perform this method, recommended contact time, temperature conditions, and other conditions are maintained as per the manufacturer’s requirements or using standard guidelines.
EN 14476 Test Procedure
- 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 the test suspension.
- The incubation period and temperature are maintained as per the manufacturer’s requirement and the 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.
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FAQs
EN 14476 is a European Standard test method that is used to determine the virucidal activity of chemical disinfectants in the medical area.
EN 14476 test applies to products such as hygienic handrub, hygienic handwash, textiles, and instrument disinfection. These products are used in hospitals, dental care facilities, nursing homes, kindergartens, and school health clinics where disinfection is important for preventing infections.
The EN 14476 test method takes 2 – 4 weeks depending on the number and type of viruses against which the test is performed.
As per the EN 14476 guideline, a limited spectrum test is performed against Adenovirus and Murine norovirus. A full spectrum test includes Poliovirus along with the viruses from the limited spectrum. Vaccinia virus is recommended for test against Envelope viruses. Furthermore, EN 14476 also has an option to test against any virus of choice such as SARS CoV-2, Beta Coronavirus (OC-43) (ATCC VR-1558), Human Coronavirus (229E) (ATCC VR-740), Influenza A (H1N1) (ATCC VR-1469) Influenza A (H3N2) (ATCC VR-1679).
