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TEST METHOD
Quantitative Suspension Test for the Evaluation of Fungicidal or Yeasticidal Activity in the Medical Area
EN 13624 is an essential European Standard used to evaluate the minimum fungicidal or yeasticidal activity requirements of various type of products used in the medical area.
The infographic below provides a brief overview of the EN 13624 test method.
Understanding EN 13624 Testing
Application areas
This testing method applies to the following product categories:
- Hygienic Handrub and Handwash
- Surgical Handrub and Handwash
- Instrument Disinfectants
- Surface Disinfectants
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 8 mL + 1 mL + 1 mL 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%. If the product does not meet the passing criteria at 80%, a modified method is available for testing at 97% concentration.
Test Microorganisms
These are the minimum test organisms:
- Candida albicans
- Aspergillus brasiliensis (not required if testing for yeasticidal efficacy only)
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.
These are the minimum contact times given by the test method:
- Hygienic handrub and handwash: Between 30 to 60 seconds
- Surgical handrub and handwash: Between 1 to 5 minutes
- Instrument disinfectant: No longer than 60 minutes
- Surface disinfectant: No longer than 5 minutes for surfaces frequently touched by different people, and no longer than 60 minutes for other surfaces
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
These are the minimum soiling conditions for the respective categories of products:
- Hygienic handrub: Clean condition
- Hygienic handwash: Dirty condition
- Surgical handrub: Clean condition
- Surgical handwash: Dirty condition
- Surface disinfectant: Clean or dirty condition
- Instrument disinfectant: Clean or dirty condition
Need help with your testing requirements?
Have questions about this test method or your product? Our technical team is here to assist you.