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TEST METHOD
Quantitative Suspension Test for the Evaluation of Mycobactericidal Activity of Chemical Disinfectants in the Medical Area Including Instrument Disinfectants
EN 14348 is an essential European Standard used to evaluate the minimum mycobactericidal activity requirements of various type of products used in the medical area.
The infographic below provides a brief overview of the EN 14348 test method.
Understanding EN 14348 Testing
Test Protocol
Step 1: Customer product is added to a mixture of the test suspension and interfering substance.
Step 2: After the selected contact time, 1 mL of the test mixture is transferred into a neutralizer containing distilled water to stop the disinfectant activity.
Step 3: After the required neutralization time, the neutralized mixture is plated and incubated. Surviving bacterial colonies are then enumerated to determine the log reduction.
The test protocol is performed under the specified conditions according to the product category and intended application.
Testing Note
For RTU products, the test preparation results in an effective product concentration of 80%. For concentrated products, the product will be prepared at 1.25× concentration to achieve 80%.
Test Microorganisms
These are the minimum test organisms:
- Mycobacterium avium (not required if testing for tuberculocidal efficacy only)
- Mycobacterium terrae
Contact Time & Concentration
The test concentration is chosen according to the manufacturer’s recommendation. The minimum contact time to be tested is 60 minutes. However, the manufacturer can test a shorter contact time, including 5, 15, and 30 minutes.
If EN 14348 is used to demonstrate mycobactericidal and/or tuberculocidal activity for hygienic handrub and handwash, surface disinfectant, or textile disinfectant, the contact times shall be chosen according to EN 13727 and EN 13624.
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 + 3.0 mL/L sheep erythrocytes
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