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EN 17430 Test
Virucidal Efficacy Test for Hygenic Handrubs
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Quick understanding of the test
EN 17430 Test - Virucidal Efficacy Test for Hygenic Handrubs
Phase 2 step 2 test to evaluate the virucidal efficacy of hygienic handrub products onto artificially contaminated hands of volunteers.
The test is applicable to hygienic handrub products used in areas where disinfection is medically indicated.
- Murine norovirus
- The hands of volunteers are contaminated with the test virus.
- Pre-sampling is conducted to determine the initial titre of the test virus.
- The test product is applied according to the manufacturerโs instructions for a specified contact time.
- After contact time, fingers are dipped into sampling fluid and the reduction in virus titre is determined.
- Ensures product efficacy by simulating real-world conditions.
- Strengthens product credibility in regulatory and commercial markets.
Turnaround Time
The test typically takes 3- 4 weeks to complete.
Results
The result is determined by comparing the mean logโโ reduction in viral titre after using a handrub, compared to the baseline (pre-treatment) level.
To pass, the handrub must demonstrate a mean log10 reduction in viral titre that is statistically significant and meets or exceeds the 4 log10 reduction benchmark set by EN 17430, compared to the pre-treatment viral load.
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Abstract
EN 17430 is a phase 2 step 2 test that specifies the test requirements and methodology for assessing the virucidal efficacy of hygienic handrub formulations under practical use conditions.
Before, EN 14476 has been used to determine the virucidal activity of hand rub formulations. However, as a phase 2 step 1 test, EN 14476 evaluates virucidal efficacy in suspension, which may not reflect real-world conditions. Whereas, EN 17430 focuses on in vivo testing by assessing efficacy of hand sanitizers on artificially contaminated hands of volunteers.
Applications of EN 17430 Standard
The standard is particularly applicable to hygienic handrub products used in areas and situations where disinfection is medically indicated. These areas may include but are not limited to:
- Hospitals, community medical facilities, dental institutions, clinics
- School clinics kindergartens, and nursing homes
- Workplaces and public spaces
- Other relevant areas such as kitchens and laundries that supply products directly to patients.
EN 17430 Test Requirement
- Test virus: Murine norovirus
- Test volunteers: 18 to 22
- Test temperature: 21.5 โ ยฑ 3.5 โ
- Contact time: Between 30s to 60s (or according to manufacturerโs recommendations)
- Passing criteria: The mean reduction in the test organism should be greater than the reduction in viral load by reference handrub (70% ethanol).
Claim requirements:
To support virucidal claims under European standards, a product must pass EN 14476:
- For full virucidal activity, it must demonstrate efficacy against Poliovirus, Adenovirus, and Murine Norovirus.
- For limited spectrum virucidal activity, it must demonstrate efficacy against Adenovirus and Murine Norovirus.
- EN 17430 can be used as an in vivo test to validate these claims under practical use conditions, strengthening product credibility.
EN 17430 Test Method
- Prior to testing, volunteersโ hands are washed thoroughly to avoid external contamination.
- Hands of volunteers are artificially contaminated with the test virus.
- Pre-sampling is performed wherein volunteers dip their fingers into sampling fluid to determine the initial virus titre.
- The test product (hygienic handrub) is applied according to the manufacturerโs instructions, ensuring thorough coverage and rubbing for a specified contact time, usually 30 seconds to 60 seconds.
- After contact time, fingers are dipped into sampling fluid and the reduction in virus titre is determined.
- Virucidal efficacy is evaluated by comparing the mean logโโ reduction in viral titre after using a handrub, compared to the baseline (pre-treatment) level.
Importance of EN 17430 Test Standard
The EN 17430 is a key standard to guarantee the effectiveness of hygienic hand rubs in fighting viral contamination, especially in the medical and healthcare environments. The standardized test method ensures the products’ virucidal effectiveness. This guarantees that the products adhere to stringent regulatory standards and aids infection control within hospitals, clinics, and other high-risk environments.
Adherence to this standard not only promotes patient and healthcare worker safety but also assists manufacturers in creating consistent, evidence-based hygiene products that prevent the transmission of infections.
Benefits of EN 17430 Test
- Simulates practical conditions: Unlike lab-only tests, this standard mimics real-world hand hygiene practices.
- Supports compliance & market access: Meets European regulatory requirements for disinfectants and antiseptics.
- Covers a wide range of use cases: Applicable to products used in hospitals, laboratories, dental clinics, nursing homes, schools, and food processing industries.
- Strengthens product claims: Enhances consumer trust by proving the product meets high safety and hygiene standards.
- Competitive market advantage: Strengthens credibility in regulatory and commercial markets.
Conclusion
For businesses seeking to certify their hand sanitizers under EN 17430, professional testing and validation services are available.
At Microbe Investigations Switzerland (MIS), we provide expert guidance and compliance support to help manufacturers meet this new standard. Additionally, we also provide EN 14476 tests to complement your EN 17430 testing needs.
Contact our experts today to learn more about our services or to schedule an appointment.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 17430 is a European standard that evaluates the virucidal efficacy of hygienic handrub products under real-use conditions by artificially contaminating volunteers hands.
EN 17430 is a Phase 2, Step 2 test that evaluates the virucidal efficacy of hygienic hand rubs under real-life conditions using human volunteers. In contrast, EN 14476 is a Phase 2, Step 1 test that assesses virucidal activity in suspension.
Murine norovirus is used to test handrub products.
Products must demonstrate a significant reduction in viral load on volunteers’ hands to meet the required efficacy threshold for virucidal activity.
The test evaluates the reduction of viral contamination on volunteersโ hands after the application of the handrub product, ensuring it meets the required reduction level.
EN 17430 is applicable to handrub products used in areas like healthcare, workplaces, public spaces, and food processing industries.
EN 17430 is a European standard, and while it is recognized across the EU and many international markets, acceptance depends on local regulatory authorities outside Europe.
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