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TEST METHOD
Quantitative Suspension Test for the Evaluation of Virucidal Activity in the Medical Area
EN 14476 is an essential European Standard used to evaluate the minimum virucidal activity requirements of various type of products used in the medical area.
The infographic below provides a brief overview of the EN 14476 test method.
Understanding EN 14476 Testing
Application Areas
The test covers the following categories of products:
- Hygienic handrub and handwash
- Instrument disinfectant
- Surface disinfectant
- Textile disinfectant
Test Protocol
Step 1: The customer product is added to a mixture of interfering substance and virus test suspension.
Step 2: The test product is neutralized by adding the contents of Test Tube A to an ice-cold medium.
Step 3: The contents of Test Tube B are further diluted, and each dilution is added to a 96-well plate.
Step 4: Cell culture medium is added to the 96-well plate, followed by observation for the presence of cytopathic effects (CPE).
Test Microorganisms
These are the mandatory test organisms for hygienic handrub and handwash:
- Poliovirus, adenovirus, and murine norovirus for a fully virucidal activity claim
- Adenovirus and murine norovirus for a limited spectrum virucidal activity claim
- Vaccinia virus for a virucidal activity against enveloped viruses claim
For instrument disinfectants:
- Poliovirus
- Adenovirus
- Murine norovirus
- If usage temperature is ≥40°C, parvovirus only
For surface disinfectants:
- Poliovirus
- Adenovirus
- Murine norovirus
For textile disinfectants:
- Parvovirus
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 contact times recommended by the test method:
- Hygienic handrub and handwash : Between 30 to 120 seconds
- 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
- Textile disinfectant: No longer than 20 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 + 3.0 mL/L sheep erythrocytes
These are the obligatory soiling conditions for the respective categories of products:
- Hygienic handrub : Clean condition
- Hygienic handwash : Dirty condition
- Instrument disinfectant : Clean or dirty condition
- Surface disinfectant : Clean or dirty condition
- Textile disinfectant : 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.