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EN 16615 (4 field method)
Evaluation of Bactericidal and Yeasticidal Activity of Disinfectant Wipes used in the Medical Area
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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
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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Abstract
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.
Scope and Applications of EN 16615 Test Method
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.
EN 16615 Test conditions and requirements
EN 16615 Test Method (4 - Field Test)
- 4-field test fields (with squares of 5 ร 5 cm) are marked on PVC (Polyvinyl chloride) with PUR (polyurethane) surface coating material.
- The first field is inoculated with a test suspension of bacteria or yeast in a solution of interfering substance and is dried.
- 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 2.3โ2.5 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.
- The swabs are put into a broth containing the neutralizer to halt further bactericidal/ yeasticidal activity of the disinfectant.
- The neutralizing extract is plated and incubated to analyze the bactericidal and yeasticidal activity of test samples.
Importance of EN 16615 Test Services
In hospital settings, inanimate surfaces are key sources of pathogenic microorganisms, making effective disinfection critical to preventing surface colonization and cross-contamination. However, studies show that cross-infection can still occur, as not all disinfectants are equally effective against resilient pathogens.
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.
Conclusion
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.
Partner with us to ensure your solutions meet the highest standards of microbial efficacy. Contact us today to learn more or schedule a consultation!
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.
EN 16615 tests can be applied for surface disinfectant products including disinfectant wipes, surgical hand rubs, and instrument disinfectants used in health care settings.
EN 16615 test takes 3-4 days to complete.
At Microbe Investigations Switzerland, we test for the EN 16615 using the following bacterial and fungal strains: Pseudomonas aeruginosa (ATCC 15442), Escherichia coli (ATCC 8739), Staphylococcus aureus (ATCC 6538P), Enterococcus hirae (ATCC 10541), Klebsiella pneumoniae (ATCC 4352), MRSA (ATCC 33591), Salmonella enterica (ATCC 10708), Candida albicans (MTCC 3017).
No, this standard is designed specifically to evaluate bactericidal and yeasticidal activity. For virucidal testing, other standards such as EN 14476 are recommended.
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