- Swiss testing laboratory
BS EN 17111:2018
Hassle-free testing experience
Need to get a product tested? No worries! To and fro logistics are on us; we collect your products, test them and, deliver them back to you.
Related tests for you
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)
- 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
Do you have a product that needs testing?
Abstract
EN 17111 test is employed for disinfectants that claim virucidal activity when used on medical instruments. EN 17111 is a phase 2, step 2 carrier test which stimulates more real conditions of practical use of the product than phase 2 step 1 suspension test.
Scope of products that can be tested with EN 17111 standard
- Surgical instruments,
- Anesthesia material,
- Endoscopes,
- Also applicable for other areas/ situations where disinfection is medically indicated.
EN 17111 Test Conditions & Requirement
EN 17111 (phase 2 step 2) | Virucidal activity against enveloped viruses
(Pre-cleaning products with a combined cleaner/disinfectant) | Virucidal activity (Instrument disinfection when temperature is < 40 ยฐC) | Virucidal activity (Instrument disinfection when temperature is โฅ 40 ยฐC) | |
Mandatory test microorganisms | Modified Vaccinia virus Ankara or Vaccinia virus strain Elstree | Adenovirus and murine norovirus | Murine parvovirus | |
Additional | Any relevant strain | |||
Test temperature | According to the manufacturerโs recommendation, but at/between | |||
20 ยฐC | 20 ยฐC and < 40 ยฐC | โฅ 40 ยฐC and 70 ยฐC | ||
Contact time | According to the manufacturerโs recommendation, but no longer than | |||
60 min | 60 min | 60 min | ||
Interfering substance – Clean conditions | 0.3 g/l bovine albumin solution | 0.3 g/l bovine albumin solution | 0.3 g/l bovine albumin solution | |
Dirty conditions | 3.0 g/l bovine albumin solution plus 3.0 ml/l washed sheep erythrocytes | 3.0 g/l bovine albumin solution plus 3.0 ml/l washed sheep erythrocytes | 3.0 g/l bovine albumin solution plus 3.0 ml/l washed sheep erythrocytes | |
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
Importance of EN 17111 Test
The nosocomial spread of viral infections (healthcare-associated infections – HAI) has become an increasing concern worldwide. Improper cleaning and disinfection of surgical instruments is identified as a key risk factor of infection among patients, hospital workers, patients attendants and visitors.
Therefore, decontamination and effective sterilization of medical equipment can play a crucial role in the prevention and control of viral outbreaks since disinfectants are regarded as the primary measure for the inactivation of viral, bacterial, and all other types of germs in medical areas.
In Europe, disinfectants labeled with virucidal claims need to be tested for their efficacy as per EU disinfectant standards. EN 17111 standard specifies test methods and optimal conditions under which disinfectant is intended to be used.
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, 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.
Meet the best of the blend of
R&D, Efficacy Testing,
Innovation and Passionate
Experts at MIS.
Explore More
In the cosmetics industry, safety
Evidently, with the expanding cosmetics
In the competitive world of
