The Importance of Virucidal Activity and the Relevance of EN 14476
Targeted inactivation of viruses is a key quality feature of modern disinfectants – especially in medical environments, laboratories, and hygiene product manufacturing. The European standard EN 14476 defines the authoritative test method for determining the virucidal activity of chemical disinfectants and antiseptics. Only products that successfully pass this standard test meet the requirements for proven medical disinfection and offer legal certainty as well as market acceptance.
EN 14476 is the European standard for the quantitative determination of virucidal activity of chemical disinfectants and antiseptics in the medical field. It defines the standardized test method, requirements, and the test viruses to be used. EN 14476 is part of the standards framework according to EN 14885, which regulates the application and interplay of all relevant disinfectant standards.
EN 14476 is part of the European standards system for disinfectants.
The overarching EN 14885 – Application of European Standards for Chemical Disinfectants defines which activity tests (e. g., virucidal, bactericidal, fungicidal) are mandatory for specific product types and claims. It provides manufacturers, laboratories, and users with a comprehensive overview of requirements and the interaction of individual test methods.
Key points
Areas of application
Applies to disinfectants and antiseptics in the medical sector (e. g., hand, surface, instrument, and laundry disinfection)Virucidal criteria
Prerequisite for claims such as “virucidal”, “limited virucidal”, or “limited spectrum virucidal PLUS”EU regulations
Mandatory for approval, listing, and quality seals in Europe
The EN 14476 test procedure is based on a quantitative suspension test (Phase 2, Step 1), which evaluates the activity of a product under practical conditions.
Procedure and Requirements:
- Test viruses: Poliovirus type 1, Adenovirus type 5, murine norovirus, possibly murine parvovirus and vaccinia virus (depending on the claim)
- Contact times: Depending on the application, between 30 seconds and 60 minutes (e. g., hands: 30 – 120 s, surfaces: ≤ 60 min, laundry: 10 – 20 min)
- Test temperatures: 20 °C (or 25 °C for alcoholic hand disinfectants with adenovirus), others depending on application
- Interfering substances: Bovine serum albumin (low soiling: 0.3 g/l; high soiling: 3.0 g/l + 3 ml/l sheep erythrocytes)
- Evaluation criterion: Demonstration of a reduction in virus titer by at least 4 log steps (for hand washing ≥ 2 log steps)
- Validation: Reference substances (e. g., glutaraldehyde, formaldehyde) and control tests ensure reliability
The procedure simulates real-world conditions and ensures that only products with proven virucidal activity meet the requirements.
Testing according to EN 14476 is essential for:
Manufacturers of disinfectants
(for hands, surfaces, instruments, textiles)Medical and care facilities
(hospitals, practices, laboratories, nursing homes)Contract laboratories and testing service providers
Industrial partners
(e.g., laundries, kitchens, pharmaceuticals, biotechnology)Authorities and regulatory bodies
(e.g., for biocidal products, medical devices)
Only tested products may be marketed with claims such as “virucidal”, “limited virucidal”, or “limited spectrum virucidal PLUS” and meet the requirements for listings (e.g., VAH, IHO, RKI).
- Legal certainty:
Compliance with legal and regulatory requirements (e. g., Biocidal Products Regulation, Medical Device Regulation, EN 14885). - Market acceptance:
Recognition by authorities, professional societies, and customers – prerequisite for listing and distribution in healthcare. - Quality seal:
Proof of activity by independent, accredited laboratories – basis for certifications and building trust. - Competitive advantage:
Positioning as a manufacturer or provider of disinfectants with proven, standard-compliant virucidal activity - Digital test report – QES-signed:
You will receive a digital test report including a professional assessment, secured with a Qualified Electronic Signature (QES). This guarantees the legal validity, integrity, and immutability of your documents – recognized across the world. Our scientific director evaluates the results of the test reports.
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Accredited Expertise & Experience
Over 30 years of testing experience, DAkkS-accredited according to EN ISO/IEC 17025 – your reliable partner for EN 14476.Modern Laboratory & Expertise
State-of-the-art equipment and experienced specialists for standards-compliant, transparent testing processes.Fast Results & Individual Consultation
Efficient testing methods including customized test design.
Virucidal testing according to EN 14476 is a standardized laboratory procedure that demonstrates whether a disinfectant achieves sufficient inactivation of viruses under practical conditions. Only products that pass this standard test may be claimed as “virucidal” or “limited virucidal”.
All disinfectants intended for use in the medical field for virus inactivation (e.g., for hands, surfaces, instruments, textiles) require successful testing according to EN 14476 to carry the corresponding claims.
EN 14476 requires the use of poliovirus, adenovirus, and murine norovirus as test viruses. Depending on the claim and application, additional viruses (e.g., vaccinia virus, murine parvovirus) may be included. Testing is performed under defined conditions regarding temperature, contact time, and interfering substances.
Only products that pass EN 14476 testing meet the requirements for approval, listing (e.g., VAH, IHO), and marketing in healthcare. The standard test provides legal certainty and is a prerequisite for acceptance by authorities, professional societies, and customers.
After submitting your product documents, we advise you on the optimal test design. Testing is carried out in our accredited laboratory according to EN 14476. You receive a detailed test report that can be used for approval, listing, and marketing.