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TEST METHOD
Quantitative Carrier Test for the Evaluation of Bactericidal Activity of Instruments Used in the Medical Area
EN 14561 is an essential European Standard used to evaluate the minimum bactericidal activity requirements of instrument disinfectant used in the medical area.
The infographic below provides a brief overview of the EN 14561 test method.
Understanding EN 14561 Testing
Application areas
This test method is only suitable to evaluate the bactericidal activity of instrument disinfectant used in medical area.
Test Protocol
Step 1: Test suspension is inoculated on a sterile glass slide.
Step 2: Inoculated glass slide is transferred into customer product.
Step 3: After contact time, glass slide is transferred into sterile neutralizer.
Step 4: After neutralization, plate 1 mL of mixture and enumerate colonies after incubation.
Test Microorganisms
These are the minimum test organisms:
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Enterococcus hirae
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 minimum contact time to be tested is 60 minutes. However, the manufacturer can test a shorter contact time, including 5, 15, and 30 minutes.
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
Need help with your testing requirements?
Have questions about this test method or your product? Our technical team is here to assist you.