Affordable
Global Footprint
Speed
LIMS system

EN 14476

Determine Virucidal activity of Disinfectants & Sanitizers

Home >> Antiviral >> EN 14476

EN 14476 Test – (Quantitative suspension test for the evaluation of virucidal activity of disinfectants used in the medical area)

EN 14476 is a key standard in microbiological testing, especially for the assessment of the virucidal action of chemical disinfectants and antiseptics used in the medical field. The purpose of this guide is to help you further explore and understand the significance of this EN standard, the testing procedures, and how it aids in setting the standard for proper disinfection processes.

Scope and application

The standard applies to products intended for use in the medical field, including but not limited to:

  • Hygienic hand rubs and hand washes
  • Instrument disinfectants
  • Surface disinfectants
  • Textile disinfectants
  • Disinfectants used in patient care, nursing homes, clinics of schools, and kindergartens

Test conditions and requirements for EN 14476 test method

 

  • Test Viruses: The standard requires that both enveloped and non-enveloped viruses be tested to simulate different levels of resistance and infection risk. Viruses used for the test include:
        1. Poliovirus
        2. Adenovirus
        3. Murine norovirus
        4. Vaccinia virus
        5. Additional viruses such as coronaviruses and influenza virus may be used depending on the relevance and specific claims of the product.
  • Test Conditions: It stipulates conditions such as temperature, contact time, and organic load (interfering substances) that might affect virucidal activity.
  • Efficacy Criteria: Products must demonstrate at least 4 log reductions in virus titers to pass the test, ensuring they perform effectively under practical conditions.

Summary of test conditions and requirements

Test Conditions 

Hygienic handrub  and handwash

Instrument  disinfection

Surface disinfection 

Textile disinfection

Mandatory  test organisms

Non – enveloped viruses

Virucidal activity 

Poliovirus 

Adenovirus 

Murine Norovirus 

Virucidal activity 

Poliovirus 

Adenovirus 

Murine Norovirus 

when the temperature is  40 °C or higher, only  Parvovirus

Virucidal activity 

Poliovirus 

Adenovirus 

Murine Norovirus 

Parvovirus

Limited spectrum   virucidal activity 

Adenovirus 

Murine Norovirus 

-NA –

Limited spectrum  virucidal activity 

 Adenovirus

Murine norovirus

-NA –

Enveloped viruses

Virucidal activity against enveloped viruses 

Vaccinia virus

-NA –

Virucidal activity against enveloped viruses 

Vaccinia virus

-NA –

Additional

Any relevant test organism

Test temperature

According to the manufacturer’s recommendation, but at/between 

20 °C

20 °C and 70 °C 

4 °C and 30 °C

30°C and 70 °C

Contact time 

According to the manufacturer’s recommendation 

between 

30 s and 120 s

But no longer than

    60 min

  5 min or 60 min

    20 min

Interfering substance – clean conditions 

0,3 g/l bovine albumin solution (hygienic handrub)

0,3 g/l bovine albumin solution 

0,3 g/l bovine albumin  solution 

3,0 g/l bovine  albumin solution plus  3,0 ml/l erythrocytes

     

Interfering substance – dirty conditions 

3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (hygienic handwash)

3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes

3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes

3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes

BS EN 14476 Test Procedure

  • Preparation: A sample product is diluted or directly added to an interfering substance.
  • Inoculation: The virus is inoculated into the test suspension.
  • Incubation: The mixture is incubated at specified conditions.
  • Inactivation: After the contact time, the virucidal action is stopped by an ice-cold maintenance medium.
  • Titration: Serial dilutions of the residual virus are performed and inoculated on cell lines to measure viral infectivity using the TCID50 assay.
  • Calculation: Reduction of virus titer under the effect of the disinfectant is calculated.
EN 14476 Test Procedure

Importance in medical settings

Patient Safety: Certified disinfectants reduce Healthcare-Associated Infections (HAIs) and restrict virus transmission in healthcare facilities.

Trust and Credibility: Certified products instill confidence in patients and healthcare staff.

Regulatory Compliance: Using certified disinfectants ensures adherence to regulatory requirements and minimizes legal risks.

Market Access and Product Endorsement: Certification allows manufacturers to access certain markets and enhances product credibility.

Global Relevance of EN 14476

Though EN 14476 is a European standard, its principles and testing procedures are universal and widely recognized globally.

If you are interested in ensuring that your disinfectants meet the highest standards of virucidal efficacy, contact Microbe Investigation Switzerland today. Our expert team is ready to provide comprehensive testing and validation services tailored to your needs. Ensure the safety and effectiveness of your products by trusting MIS for all your microbiology testing requirements.

FAQs

Yes, compliance with EN 14476 is recognized globally and can aid in acquiring approvals in various countries due to its stringent testing requirements.

Products such as hygienic hand rubs, hand washes, textile disinfectants, surface disinfectants, and instrument disinfectants can be tested with EN 14476.

Typically, the test takes 2 to 4 weeks to complete, depending on the number of viruses tested.

Strict safety measures including the use of biosafety cabinets, PPE, proper disposal of biohazard waste, and adherence to GLP guidelines.

Common challenges faced during this test include maintaining a consistent virus titer for comparative studies, avoiding any risk of contamination between the samples, the stability of the virus during the testing process, and accurate measurement of the reduction of viral activity. In addition, differences in product formulations create variabilities in outcomes therefore care must be taken during preparation and standardization.

The results of this test can significantly improve the marketability of your product based on the proof of antiviral effectiveness. This certification guarantees users and regulatory authorities that the product meets high European standards for disinfectants, thereby differentiating the product from competitors and boosting consumer confidence.

This standard is a European test method that evaluates the virucidal activity of chemical disinfectants. In comparison, US regulations, such as those enforced by both EPA and FDA, include similar efficacy testing that would apply different methods and possibly different viruses for testing. In either case, the goal is to ensure that a product will be effective against viral pathogens, although regulatory requirements and accepted test protocols differ.

The results obtained from this test will be useful in highlighting the strengths and weaknesses of your products. This information can be used to enhance your formulation to improve the efficacy of the product. Also, conducting these tests ensures compliance with regulatory standards.

This test validates the hand sanitizers by measuring the reduction in viral load on the skin or another surface. In this test, the test virus and the surface contaminated with it are treated with a sanitizer, and the reduction in viral infectivity is determined. A product exhibiting at least 4 log reduction in viral activity as per the requirements of the standard is considered to be effective.

The key differences between EN 14476 and other assays for viral efficacy are mainly associated with specific protocols, viruses tested, and applied performance criteria. Other assays from organizations like the US EPA will have different requirements and test methods. Apart from that, specific conditions of the tests and log reduction criteria under EN 14476 are different from those in other standards, thus making this assay a unique antiviral efficacy assessment tool.

Contact us for more information



    Explore Other Tests

    Leaving Already?

    Did not find the information you were looking for or need something specific!


      Sign up with Us! Enter your email address for a 10% discount!