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BS EN 16777
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Quick understanding of the test
BS EN 16777 - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in medical area.
Application
Applicable to disinfectants used in hospitals, medical centers, dental clinics, nursing homes, and school infirmaries.
- Adenovirus
- Norovirus
- Vaccinia virus
- The viral suspension with interfering substance is applied to discs and is allowed to dry.
- The dried surfaces are treated with disinfectant under specified conditions of temperature and contact time.
- After neutralization, the titre of virus inoculum is determined and reduction in virus titre is compared to the control sample.
- Validates disinfectants for effective viral pathogen reduction, ensuring hygiene and infection control in medical settings.
- Helps manufacturers develop high-quality virucidal products compliant with European standards.
Passing criteria
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Abstract
EN 16777 (phase 2, step 2) is a quantitative suspension test for the determination of virucidal activity of products intended for use in medical areas for disinfecting non-porous surfaces including surfaces of medical devices without mechanical action.
EN 16777 test is applicable to the situations and/or areas where disinfection is medically indicated including –
- hospitals,
- medical care centres,
- nursing homes,
- infirmaries of schools,
- And dental care facilities.
In addition, suspension test EN 14476 is also used to assess the virucidal activity of disinfectant products.
EN 16777 Test Conditions and Requirements
- Test microorganisms used – SARS CoV-2 (Omicron, Delta, Wuhan variant), Betacoronavirus 1 (OC43) (ATCC VR-1558), Human coronavirus 229E (ATCC VR-740), Influenza A (H1N1) (ATCC VR-1469), Influenza A (H3N2) (ATCC VR-1679), Human Poliovirus type 1 (FLI LSc-2ab), Human Adenovirus type 5 (ATCC VR-5), Murine Norovirus (FLI S99), Vaccinia virus (ATCC VR-1549), and Feline calicivirus (FLI strain F-9)
- Test temperature – Between 18 °C and 25 °C
- Contact time – As per manufacturer’s recommendations, but no longer than 5 or 60 minutes
- Interfering substance – Clean Conditions: 0.3g/l bovine albumin solution and Dirty conditions: 3g/l of bovine albumin solution plus 3 ml of erythrocytes
- Log reduction – Tested product must achieve 4 log reduction value to pass EN 16777 standard
EN 16777 Test Method (Carrier test)
- Virus suspension is mixed with interfering substances (for both dry and clean conditions) and spread over the stainless-steel disc (test surface). Then, surface is allowed to dry out.
- In the next step, disinfectant is applied on the dried inoculated test surface and kept under specific temperature and contact period times.
- At the end of the contact period, treated test surfaces are transferred into the cell maintenance medium to neutralize the reaction.
- Infectious titre of virus recovered from test surface is determined and results are compared with infectious titre of virus from control sample (discs treated with hard water).
- According to EN 16777 standard, a sample product to exhibit virucidal activity or limited spectrum virucidal activity must possess 4 log reduction in virus titre.
Importance of EN 16777
In hospital environments, chemical disinfectants play a pivotal role to reduce the risk of infections by eliminating or reducing pathogenic microbes.
Based on epidemiological studies, contaminated hospital surfaces are one of the major risk factors leading to cross-contamination and nosocomial infections.
The European Standard (EN 16777) is established to check whether virucidal agents used in chemical disinfectants are capable of destroying or inactivating viral pathogens. In addition, this test helps manufacturers to develop high-quality virucidal products that ensure proper hygiene and infection prevention.
Conclusion
At MIS, we perform both suspension (EN 14476) and carrier (EN 16777) test methods to determine the virucidal activity of chemical disinfectants.
Our experts understand testing requirements and conduct testing and analysis that is most appropriate for our client’s products.
In addition, we are specialized in evaluating the antibacterial efficacy of detergent formulations used in medical, food, and other areas. EN 1276, EN 16615, EN 13693, PAS2424, AOAC Use Dilution Test, and so on are performed for antibacterial disinfectant products at MIS.
Looking for EN 16777 testing of your products, please contact our experts here for more details.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 16777 standard specifies the non-porous surface test method to determine the virucidal activity of chemical disinfectants used in medical areas.
EN 16777 test applies to the products used for disinfection in hospitals, dental care facilities,
medical care centres, nursing homes, and infirmaries of schools and kindergartens.
EN 16777 test takes 4-5 weeks to complete.
At Microbe Investigations, we test for EN 16777 using the following microbial strains:
SARS CoV-2 (Omicron, Delta, Wuhan variant), Betacoronavirus 1 (OC43) (ATCC VR-1558), Human coronavirus 229E (ATCC VR-740), Influenza A (H1N1) (ATCC VR-1469), Influenza A (H3N2) (ATCC VR-1679), Human Poliovirus type 1 (FLI LSc-2ab), Human Adenovirus type 5 (ATCC VR-5), Murine Norovirus (FLI S99), Vaccinia virus (ATCC VR-1549), and Feline calicivirus (FLI strain F-9).
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