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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 17111 is a Phase 2 step 2 quantitative carrier test specifically designed to evaluate the virucidal efficacy of chemical disinfectants and antiseptics intended for medical instruments. As a carrier test, it closely simulates real-world conditions and ensures that disinfectants are tested under stringent conditions to verify their effectiveness in infection-sensitive settings.
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
EN 17111 is a critical European standard that defines a quantitative carrier test method for evaluating the virucidal activity of chemical disinfectants and antiseptics specifically used for medical instruments. Its primary importance lies in ensuring that disinfectants used in healthcare settings are not only effective under ideal lab conditions but also under realistic clinical conditions, such as the presence of organic matter (e.g., blood, proteins) and varying temperatures. The standard simulates the actual application conditions, such as viruses dried onto surfaces and later exposed to disinfectants during immersion cleaning. This makes it particularly relevant for surgical instruments, endoscopes, and anesthesia equipment, where viral contamination poses a significant risk.
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, EN 16777 test is also available for disinfectant virucidal claims in MIS lab.
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 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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