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BS EN 17111:2018
Evaluation of virucidal activity for instrument disinfectants used in the medical area
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Quick understanding of the test
BS EN 17111:2018 - Quantitative carrier test for the evaluation of virucidal activity for instruments used in the medical area (phase 2, step 2)
Applicable to disinfectant products intended for disinfection of medical instruments in areas such as hospitals, nursing homes, dental clinics and more.
- Modified Vaccinia virus Ankara or Vaccinia virus strain Elstree
- Adenovirus
- Murine Norovirus
- Murine Parvovirus
- Test suspension of viruses with interfering substances is spread on a glass carrier and allowed to dry.
- The carrier with the dried inoculum is immersed in disinfectant.
- At the end of contact time, the carriers are transferred into a maintenance medium. Viruses are recovered from the carrier surfaces by shaking and viral titre assay is performed to determine the number of viable viral particles.
- Helps manufacturers comply with European market regulations for successful market entry.
- Simulates real-world application scenarios to validate the product's efficacy.
Turnaround Time
Passing criteria
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Abstract
EN 17711 is a quantitative carrier test designed to evaluate the virucidal efficacy of chemical disinfectants and antiseptics intended for disinfection of medical instruments. The test simulates real-world conditions by applying a viral suspension to a defined carrier surface, allowing it to dry, and then exposing it to the disinfectant. This Phase 2, Step 2 test employs the carrier surface to mimic contamination scenarios relevant to surgical instruments, anesthesia equipment, and other reusable medical devices requiring immersion disinfection
EN 17111 complements EN 16777, which assesses virucidal activity on non-porous surfaces without immersion or mechanical action. It also extends the principles of EN 14476 (phase 2 step 1 test) which establishes the baseline for virucidal efficacy assessment to more practical conditions. For a product to claim general virucidal activity, it must meet EN 14476 requirements with Poliovirus, Adenovirus, and murine Norovirus, and EN 16777 requirements with Adenovirus and murine Norovirus
Scope of products that can be tested with EN 17111 standard
The EN 17111 standard is applicable to chemical disinfectant and antiseptic products used for disinfection of medical instruments via immersion. This includes products intended for use in:
- Hospitals and surgical centers
- Community healthcare facilities
- Dental clinics
- Nursing homes and elder care centers
- Clinics at schools and kindergartens
EN 17111 Test Conditions & Requirements
EN 17111 Test Method
- Test suspension of viruses with interfering substances is spread on a glass carrier and allowed to dry. This is kept to dry out for sometime.
- In the next step, the carrier with the dried inoculum is immersed into disinfectant. In parallel, a control test is run wherein the glass carrier is immersed in hard water (control sample) instead of disinfectant.
- Both treated and control samples are maintained for specific contact times.
- At the end of contact time, the carriers are further transferred into a maintenance medium containing glass beads. Viruses are recovered from the carrier surfaces by shaking.
- The maintenance medium with the recovered virus is subjected to infectious viral titer assay to determine the number of viable viral particles.
- Virucidal activity is calculated by comparing the results of treated sample with control sample
Passing Criteria
To pass the EN 17111 test, the disinfectant product must demonstrate a โฅ 4 log reduction in comparison to the control test.
Importance of EN 17111 Test
Hospital-acquired infections pose a serious risk to patient safety, and ineffective disinfection of medical instruments can be a major source of viral transmission. EN 17111 addresses this problem by evaluating the virucidal efficacy of chemical disinfectants on instruments under realistic conditions.
By simulating real-world conditions, including organic soiling, use of carrier surfaces and drying of viral suspensions, it ensures reliable disinfection of instruments. The standard establishes precise efficacy criteria guiding manufacturers in product development and optimization.
Conclusion
MIS performs routine virucidal tests for disinfectants implied to be used in different areas of applications.
Our state-of-the-art testing facility is one of only a few facilities worldwide which provides efficacy research and data for products that have antiviral/ virucidal potential.
Additionally, MIS offers the EN 16777 test to support virucidal efficacy claims for disinfectants.
To get a quote on the EN 17111 test or need any additional information regarding our testing services, please contact our experts today.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 17111 test is designed to check activity of virucidal products intended for instrument disinfection in medical areas. As phase 2 step 2 carrier test, EN 17111 stimulates real-life conditions to ensure whether or not disinfectant products are capable of inactivating the viruses.
EN 17111 test is applicable to products designed to be used for the disinfection of surgical instruments, anesthesia materials, endoscopes, etc.
EN 17111 is a quantitative carrier test that evaluates the virucidal efficacy of products intended for medical instruments disinfection by immersion while EN 16777 is a surface test that assesses virucidal activity on non-porous surfaces without mechanical action.
EN 17111 test takes 4-5 weeks to complete.
At Microbe Investigations Switzerland, we test for EN 17111 using the following viral strains: Vaccinia virus strain Elstree (ATCC VR-1549), Human Adenovirus 5 (ATCC VR-5), and Murine Norovirus S99. However, we can use other viruses as per the need/request from the client.
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