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 shows a brief insight of EN 16615.
CUSTOMER PROCESS
Step 1: Which category does your product fall under?
These are the categories of test products tested under EN 16615:
- Surface disinfectant
- Ready-to-use wipes pre-soaked with surface disinfectant
Step 2: Select your 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.
Step 3: Select an appropriate contact time and concentration for your test product
The test concentration is chosen according to the manufacturer’s recommendation.
These are the minimum contact times given by the test method:
- Between 1 to 5 minutes for surfaces which are frequently touched by different people
- Between 1 to 60 minutes for other surfaces
Step 4: What are the soiling conditions associated with your test product?
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
Step 5: Place an order and send your sample to us
Fill the test request form and place an order via email at info@tecolab-global.com. We will advise on the quantity of sample required for testing.
You can deliver the sample to us via courier and provide us the tracking code. We will monitor the delivery status and inform you when we receive the sample.
Step 6: Track the status of your request
Step 7: Download your password-protected test report
Download your readily available test report online with just a single click using the link and password provided via email notification. We will receive a notification once you have downloaded the test report.
For safety purposes, the uploaded test report will self-destruct after 7 days.
Step 8: Analyze your passing criteria in the test report with our laboratory experts
In order to pass the test, the product shall demonstrate at least a 5 decimal log (lg) reduction for bacteria and at least a 4 decimal log (lg) reduction for yeast on test field 1. The mean number of colonies on test fields 2 to 4 shall not exceed 50.
Need assistance with your test report? Discuss your results with our microbiologists for more information.
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