BS EN 17111:2018 – Quantitative carrier test for the evaluation of virucidal activity for instruments used in the medical area (phase 2, step 2)
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
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EN 17111 (phase 2 step 2) |
Virucidal activity against enveloped viruses
(Pre-cleaning products with a combined cleaner/disinfectant )
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Virucidal activity
( Instrument disinfection when temperature is < 40 °C )
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Virucidal activity
(Instrument disinfection when temperature is ≥ 40 °C) |
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Mandatory test microorganisms |
Modified Vaccinia virus Ankara or Vaccinia virus strain Elstree |
Adenovirus and murine norovirus |
Murine parvovirus |
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Additional |
Any relevant strain |
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Test temperature |
According to the manufacturer’s recommendation, but at/between |
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20 °C |
20 °C and < 40 °C |
≥ 40 °C and 70 °C |
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Contact time |
According to the manufacturer’s recommendation , but no longer than |
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60 min |
60 min |
60 min |
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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 |
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Dirty conditions |
3.0 g/l bovine albumin solution plus 3.0 ml/l washed sheep erythrocytes
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3.0 g/l bovine albumin solution plus 3.0 ml/l washed sheep erythrocytes
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3.0 g/l bovine albumin solution plus 3.0 ml/l washed sheep erythrocytes
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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 prevention and control of viral outbreaks. Since disinfectants are regarded as the primary measure for 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.
MIS performs routine virucidal tests for disinfectants implied to use 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.
FAQs
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 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.
Contact us for more information
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