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EN 14476 Test
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Quick understanding about test
EN 14476 Test - Quantitative suspension test for the evaluation of virucidal activity of disinfectants used in the medical area
- Non-enveloped viruses: Poliovirus, Adenovirus, Murine Norovirus (Parvovirus for high temperatures).
- Enveloped viruses: Vaccinia virus.
- The disinfectant is inoculated with test viruses and incubated under specified conditions. After the contact time, the virucidal action is stopped, and viral infectivity is measured using the TCID50 assay.
- Ensures patient safety by reducing healthcare-associated infections.
- Enhances regulatory compliance and market credibility.
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Abstract
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:
- Poliovirus
- Adenovirus
- Murine norovirus
- Vaccinia virus
- 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 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 |
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.
Importance in medical settings
1. Patient Safety
2. Trust and Credibility
3. Regulatory Compliance
4. 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.
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Frequently Asked Questions
DR. Martinoz Scholtz
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.
As per this standard, a limited spectrum test is performed with Adenovirus and Murine norovirus. A full spectrum test includes the Poliovirus in addition to the limited spectrum viruses. For testing against enveloped viruses, the use of Vaccinia virus is recommended. This standard also allows for testing with a virus of the product manufacturer’s choice like SARS CoV-2, Beta Coronavirus (OC-43), Human Coronavirus (229E), Influenza A (H1N1) or Influenza A (H3N2), etc.
Strict safety measures include the use of biosafety cabinets and 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, maintaining the stability of the virus during the testing process, and accurately measuring 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.
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