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EN 16615 - Evaluation of Bactericidal and Yeasticidal Activity of Disinfectant Wipes Used in the Medical Area
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Summary
EN 16615 is a phase 2 step 2 quantitative test standard used to evaluate the efficacy of disinfectant wipes on non-porous surfaces. It involves wiping a contaminated surface across four defined fields under controlled conditions. The method assesses both the disinfectant action and the risk of microorganisms contamination during the wiping process. The method is commonly used to substantiate bactericidal and fungicidal claims for disinfectant products intended for disinfection of medical devices and surfaces via wiping.
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Quick understanding of the test
EN 16615 - Evaluation of Bactericidal and Yeasticidal Activity of Disinfectant Wipes used in the Medical Area
EN 16615 test is a quantitative carrier test for determining the bactericidal and yeasticidal activity of hospital-grade disinfectant wipes.
Application
- Pseudomonas aeruginosa (ATCC 15442)
- Staphylococcus aureus (ATCC 6538P)
- Enterococcus hirae (ATCC 10541)
- Candida albicans (MTCC 3017)
- Test surfaces are divided into four fields, inoculated with microbial suspension, and allowed to dry.
- After drying, disinfectant wipes are moved across the fields with a specified weight to mimic hand wiping.
- After the contact time, microorganisms are extracted using cotton swabs.
- Cotton swabs are transferred to a neutralizing solution, followed by plating, and incubation to determine viable microorganisms.
Benefits
- Assesses both antimicrobial activity and mechanical removal of microbes.
- Tests for both bactericidal and yeasticidal activity, thus allowing a broad spectrum of microorganisms to be tested.
Turnaround Time
Passing criteria
To meet EN 16615 standards, the disinfectant wipe must achieve:
- 5-log reduction for bactericidal activity.
- 4-log reduction for yeasticidal activity.
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What is EN 16615?
EN 16615 test, also known as the 4 field test, is a quantitative test method for determining the bactericidal and yeasticidal activity of hospital-grade disinfectant wipes. This phase 2 step 2 test method assesses the efficacy of disinfectant wipes in eliminating bacteria and yeast from non-porous surfaces using mechanical action.
Prior to EN 16615, standard methods used to check the efficacy of disinfectant products were not able to clarify the mechanical removal of test organisms in real conditions. EN 16615 standard thoroughly assesses the efficacy of disinfectant wipes including bactericidal and yeasticidal activity, and mechanical removal of microbial contamination.
EN 16615 Test conditions and requirements
Test organisms |
|
Test temperature | In between 4 °C and 30 °C |
Contact time | As suggested by the manufacturer (should not exceed 60 minutes) |
Interfering substance |
|
Log reduction |
|
EN 16615 Test Method (4 - Field Test)
1.4-Field surface setup
- 4-field test fields (with squares of 5 × 5 cm) are marked on PVC (Polyvinyl chloride) with PUR (polyurethane) surface coating material.
2.Inoculation and drying of microorganisms
- The first field is inoculated with a test suspension of bacteria or yeast in a solution of interfering substance and is dried.
3.Wiping simulation with standard pressure
- After the drying of the inoculum on test surfaces, test wipes are rapidly moved to and fro (from fields 1- 4 and back). A specific weight (approximately 2.3–2.5 kg) is attached to the test wipes. This weight ensures the same pressure on the test surface which is usually created while wiping the surfaces with hands.
- At the end of the contact time, test organisms are extracted from each test field using moistened cotton swabs.
4.Neutralization and recovery
- The swabs are put into a broth containing the neutralizer to halt further bactericidal/ yeasticidal activity of the disinfectant.
5.Enumeration and log reduction calculation
- The neutralizing extract is plated and incubated to analyze the bactericidal and yeasticidal activity of test samples.
Understanding EN 16615 results and Log reduction criteria
EN 16615 measures log reduction of microbial load in the initial field and prevention of microbial transfer in 2, 3 and 4 fields.
Log reduction criteria:
- ≥ 5 log reduction in field 1 for bactericidal activity
- ≥ 4 log reduction in field 1 for yeasticidal activity
- Mean of CFU ≤ 50 in field 2 – 4
Water control – Mean of CFU ≥ 10
Scope of EN 16615 standard
The standard is applicable to disinfectant products that are used in medical areas to disinfect non-porous surfaces. This includes ready-to-use wipes which are impregnated with antimicrobial agents. The standard applies to areas and sectors where disinfection is medically necessary such as:
- Hospitals and dental institutions.
- Community medical facilities
- Clinics of Schools, nursing homes, and workplaces.
- Instrument disinfectants and products regulated under the EU Medical Devices Directive.
- Other Areas: Laundry disinfectants and those used in kitchens that supply products directly to patients.
Test organisms used in EN 16615
For bactericidal activity –
- Staphylococcus aureus (ATCC 6538)
- Pseudomonas aeruginosa (ATCC 15442)
- Enterococcus hirae (ATCC 10541)
For yeasticidal activity –
- Candida albicans (ATCC 10231)
Regulatory relevance of EN 16615
EN 16615 plays a critical role in evaluating disinfectant efficacy for products intended for healthcare environments, particularly wipes used on non-porous surfaces. EN 16615 provides validated, real-world evidence of bactericidal and fungicidal activity. The standard supports compliance with European regulatory frameworks such as biocidal products regulation (BPR) by providing evidence of performance under real-world conditions. Regulatory authorities often expect data generated from EN 16615 testing if the claims involve surface disinfection through wiping.
The standard ensures that the disinfectants approved for market release meet stringent regulatory requirements. Manufacturers can demonstrate their compliance with regulations by showcasing the efficacy test results. This also facilitates manufacturers in smooth navigation through the product approval process. Successfully tested products instill a sense of confidence and trust among customers and professionals alike.
Why products fail EN 16615 testing
Possible reasons for a product to fail EN 16615 could be:
- Insufficient disinfectant concentration
- Poor formulation stability
- Uneven liquid release from wipes
- Inadequate contact time during wiping.
- Testing errors
Rechecking the formulation, concentration and performing a retest can help improve the product’s efficacy
Why choose MIS for EN 16615 testing
At Microbe Investigations Switzerland (MIS), we provide accurate and compliant EN 16615 testing to validate the efficacy of your disinfectant products. Our expertise extends to other Phase 2 Step 2 tests, including EN 1650, EN 12791, and EN 13697, ensuring comprehensive microbial efficacy assessment.
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Frequently Asked Questions
DR. Martinoz Scholtz
EN 16615 test or 4 field test is the standard protocol that specifies the test procedure for determining the bactericidal and yeasticidal activity of disinfectant wipes intended to be used in hospitals for disinfection of non porous surfaces.
EN 16615 helps validate the efficacy of disinfectant wipes with mechanical action under real-world conditions. It stimulates practical use and provides results on the wipe performance which is considered credible among the regulatory authorities to support claims related to disinfectant wipes.
The test requires :
- ≥ 5 log reduction for bactericidal activity
- ≥ 4 log reduction for yeasticidal activity
Yes, EN 16615 specially assesses the cross contamination or spread of microbes across adjacent surfaces during wiping.
EN 16615 test uses non-porous surfaces, typically standardized Polyvinyl chloride (PVC) or similar coated plastic carriers that simulate medical and environmental surfaces.
EN 16615 typically takes 1 week to complete.
No, this standard is designed specifically to evaluate bactericidal and yeasticidal activity. For virucidal testing, other standards such as EN 14476 are recommended.
EN 16615 is a phase step 2 carrier test which closely replicates the real world conditions by testing the product against dried microorganisms on surfaces.
The tests can be applied for disinfectants in healthcare settings such as surface disinfectant products including disinfectant wipes, surgical hand rubs, and instrument disinfectants.
Apart from the mandatory strains, MIS can provide testing against relevant additional strains upon manufacturers requirement.
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