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EN 17111:2018 Virucidal Carrier Test for Medical Instrument Disinfectants
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Summary
EN 17111:2018 is a quantitative carrier test used to validate virucidal claims for medical instrument disinfectants under practical conditions. It simulates real-use contamination on surfaces and confirms whether your formulation achieves the required โฅ4-log viral reduction. For manufacturers, EN 17111 is a critical standard to substantiate virucidal claims for instrument disinfectants within the European regulatory framework.
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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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What is EN 17111 Virucidal Testing?
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 EN 17111:2018 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
Viruses Required Under EN 17111
- Modified Vaccinia virus Ankara or Vaccinia virus strain Elstree
- Adenovirus
- Murine Norovirus
- Murine Parvovirus
EN 17111 Test Conditions & Requirements
| Parameter | Pre-cleaning products (Cleaner/Disinfectant) | Instrument disinfection (< 40 ยฐC) | Instrument disinfection (โฅ 40 ยฐC) |
|---|---|---|---|
| Virucidal activity scope | Virucidal activity against enveloped viruses | Virucidal activity | Virucidal activity |
| Mandatory test microorganisms | Modified Vaccinia virus Ankara (MVA) or Vaccinia virus strain Elstree | Adenovirus and Murine norovirus | Murine parvovirus |
| Additional microorganisms | Any relevant strain | Any relevant strain | Any relevant strain |
| Test temperature | According to manufacturerโs recommendation, but at 20 ยฐC | According to manufacturerโs recommendation, between 20 ยฐC and < 40 ยฐC | According to manufacturerโs recommendation, between โฅ 40 ยฐC and 70 ยฐC |
| Contact time | According to manufacturerโs recommendation, but โค 60 min | According to manufacturerโs recommendation, but โค 60 min | According to manufacturerโs recommendation, but โค 60 min |
| Interfering substance โ Clean conditions | 0.3 g/L bovine albumin solution | 0.3 g/L bovine albumin solution | 0.3 g/L bovine albumin solution |
| Interfering substance โ Dirty conditions | 3.0 g/L bovine albumin solution + 3.0 mL/L washed sheep erythrocytes | 3.0 g/L bovine albumin solution + 3.0 mL/L washed sheep erythrocytes | 3.0 g/L bovine albumin solution + 3.0 mL/L washed sheep erythrocytes |
EN 17111 Test Procedure
Carrier preparation & drying
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.
Exposure of contaminated dried carriers to the disinfectant
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.
Neutralization & Viral Recovery
- 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 the treated sample with the control sample.
EN 17111 Log Reduction Requirements
To pass the EN 17111 test, the disinfectant product must demonstrate a โฅ 4 log reduction in comparison to the control test.
EN 17111 vs Other Standards
Category | EN 17111 | EN 16777 | EN 14476 |
Purpose | Evaluates virucidal efficacy of disinfectants used for immersion of medical instruments under simulated practical conditions | Evaluates virucidal efficacy of disinfectants for non-porous surfaces in medical areas under practical conditions | Evaluates virucidal activity in a quantitative suspension test under defined lab conditions |
Test Phase | Phase 2 Step 2 (Carrier test) | Phase 2 Step 2 (Carrier test) | Phase 2 Step 1 (Suspension test) |
Mandatory test organisms | Adenovirus, Murine Norovirus, Murine parvovirus, Modified Vaccinia virus Ankara | Adenovirus and Murine Norovirus for general virucidal claims Vaccinia virus for enveloped virus claims | Enveloped & non-enveloped viruses such as Poliovirus, Adenovirus, Murine Norovirus, Vaccinia virus |
Scope of products | Disinfectants for immersion of medical instruments and devices | Disinfectants intended for non-porous surface disinfection in medical areas without mechanical action | Disinfectants, antiseptics, hand hygiene products, and textile disinfectants for medical/healthcare applications |
Passing criteria (Log reduction) | โฅ 4 log reduction | โฅ 4 log reduction | โฅ 4 log reduction |
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.
Why Choose Our Lab for EN 17111 Testing
Microbe Investigations Switzerland ensures your textile products meet the highest antiviral performance standards by deliver reliable protection. Our EN 17111 testing services provide robust, standardized antiviral efficacy data to support product compliance, strengthen regulatory acceptance, and reinforce customer confidence in your hygiene and performance claims.
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Frequently Asked Questions
DR. Martinoz Scholtz
Itโs a quantitative carrier test for evaluating the virucidal activity of chemical disinfectants and antiseptics used to immerse medical instruments under practical conditions (Phase 2, Step 2).
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.
A disinfectant must achieve at least a 4 log10 (โฅ99.99%) reduction to meet the passing criteria.
EN 17111 is a carrier surface test simulating real-world instrument disinfection (Phase 2, Step 2), while EN 14476 is a suspension test (Phase 2, Step 1) conducted in liquid.
If your product is intended for immersion disinfection of medical instruments, Phase 2 Step 2 data is typically expected to support virucidal claims in Europe.
Adenovirus, Murine norovirus, modified Vaccinia virus Ankara (and/or vaccinia Elstree), and Murine parvovirus.
It refers to a European standard testing stage where products are evaluated under realistic practical conditions (e.g, dried virus on carriers) for efficacy, beyond basic suspension tests (Phase 2 Step 1).
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