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TEST METHOD
Quantitative Test Method for the Evaluation of Bactericidal and Yeasticidal/Fungicidal and/or Tuberculocidal/Mycobactericidal Activity on Non-Porous Surfaces with Mechanical Action Employing Wipes in the Medical Area (4-Field Test)
EN 16615 is an essential European Standard used to evaluate the minimum bactericidal, yeasticidal/fungicidal and tuberculocidal/mycobactericidal activity requirements of wipes used in the medical area.
The infographic below provides a brief overview of the EN 16615 test method.
Understanding EN 16615 Testing
Application areas
These are the categories of test products tested under EN 16615:
- Surface disinfectant
- Ready-to-use wipes pre-soaked with surface disinfectant
Test Protocol
Step 1: The test suspension is inoculated onto test field 1 and allowed to dry.
Step 2: The unitary weight with the test wipe is moved from test field 1 to test field 4, followed by movement back from test field 4 to test field 1.
Step 3: After the selected contact time, sampling on each test field is performed using cotton swabs soaked in neutralizer.
Step 4: After the required mixing time, 1 mL of the neutralized mixture is plated and incubated. Surviving microbial colonies are then enumerated to determine the log reduction and assess microbial spread across the test fields.
The test protocol is performed under the specified conditions according to the product category, intended application, contact time and test conditions.
Test Microorganisms
These are the minimum test organisms for:
Bactericidal activity
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Enterococcus hirae
Yeasticidal/fungicidal activity
- Candida albicans
- Aspergillus brasiliensis (additionally for fungicidal activity)
Mycobactericidal/tuberculocidal activity
- Mycobacterium terrae
- Mycobacterium avium (additionally for mycobactericidal activity)
Wish to add more microorganisms? Click here for our full list of microorganisms.
Contact Time & Concentration
The test concentration is chosen according to the manufacturer’s recommendation.
The contact time should be chosen at a minimum of 1 minute and no longer than 60 minutes, depending on the manufacturer’s recommendation and practicality of use of the product.
Soiling Conditions
Interfering substances, or commonly referred to as soiling, are used to mimic organic substances found on human skin, surfaces, and instruments. These are the available soiling conditions according to the test method:
- Clean condition: 0.3 g/L bovine serum albumin
- Dirty condition: 3.0 g/L bovine serum albumin and 3.0 mL/L sheep erythrocytes
Repetitions and Precision
This test method lays out specific repetitions according to the following test schedule:
- Test Run 1: 1 carrier, 2 concentrations/contact times
- Test Run 2: 2 carriers, against the most resistant strain, claimed concentration and contact time
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