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BS EN 1499: 2013
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Quick understanding of the test
BS EN 1499: 2013 - Chemical Disinfectant and Antiseptics. Hygienic Handwash (phase 2, step 2 test)
- Escherichia coli K12
- Volunteers’ hands are washed to remove impurities.
- Hands are artificially contaminated with a microbial suspension.
- Pre-values of viable bacteria are determined.
- Contaminated hands are washed with the test product for the specified contact time.
- After the contact time, fingers are placed in a neutralizing solution.
- The neutralized extract is plated and incubated to determine the remaining viable microorganisms.
- By using human volunteers, the test demonstrates the product's effectiveness under practical usage conditions.
- Provides a quantitative analysis of the productโs efficacy rather than qualitative results.
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Passing criteria
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Abstract
Hygienic hand wash products must undergo rigorous testing and meet stringent regulatory standards to ensure their safety and efficacy before they are launched in the European market. BS EN 1499 plays a crucial role in this evaluation process. It is a phase 2 step 2 quantitative suspension test used for evaluating the efficacy of hygienic hand wash products in reducing transient microbial flora. This test simulates real-world conditions to provide a reliable measure of how well these products perform in reducing microbial load.
Products tested
BS EN 1499 is applicable to antimicrobial handwash intended to be used in environments where disinfection is medically indicated. This includes areas such as hospitals, community medical facilities, dental institutions, clinics in schools, kindergartens, nursing homes, workplaces, homes, and services like laundries and kitchens, providing direct product supply to patients.
BS EN 1499 Test Conditions & Requirement
Mandatory test organisms: Escherichia coli K12
Subjects: The test is conducted on 12-15 volunteers. The volunteers are divided into 2 groups, namely, control and test. Volunteers’ hands are artificially contaminated with the test organism, i.e., Escherichia coli.
Contact time: 30-60 seconds or as per the manufacturerโs instructions.
BS EN 1499 Test Method
Preparation
Before contamination, the hands of both groups (control and test) are washed to remove dirt and other impurities.
Contamination
Hands are immersed in microbial suspension and dried. Pre-values of viable bacteria are determined by dipping fingertips into tryptic soy broth (TSB).
Handwashing
Contaminated hands are washed with the hand wash product for 30-60 seconds or as per the manufacturerโs recommendation.
Neutralization
After the specified contact time, fingers are placed in a neutralizing solution to recover the remaining viable microorganisms.
Incubation and counting
A portion of the neutralized extract is plated and incubated to determine the remaining viable microorganisms.
Result analysis
Results are analyzed by comparing the number of microorganisms isolated from contaminated hands that were washed with the test product to the microorganisms recovered from contaminated hands that were washed with unmedicated liquid soap.
Passing Criteria
To pass the EN 1499 test, the mean reduction in the release of microbes achieved by the hygienic handwash with the product under test should be larger than that achieved by a specified reference hygienic handwash (unmedicated liquid soap).
Importance of BS EN 1499 Test
BS EN 1499 plays an important role in public health by providing a standardized, objective measure of a product’s efficacy against microorganisms.
Benefits of Performing the Test
- Regulatory compliance: Testing helps manufacturers meet international regulatory requirements thus ensuring their products are safe and effective for use.
- Builds consumer trust: Products that pass the test are trusted to provide reliable protection against harmful microorganisms. This aids in enhancing consumer confidence.
- Supports market access: Compliance with this standard can be a requirement for market entry in various regions. Thus, compliance facilitates wider distribution and acceptance of the product.
Conclusion
At Microbe Investigations Switzerland, we specialize in EN 1499 testing to assess the efficacy of handwash products. Our expert team is committed to delivering precise and reliable results, ensuring your products are capable of reducing the microbial load on treated surfaces.
To learn more about our EN 1499 handwash efficacy testing or to schedule a consultation, please contact our specialists today.
Frequently Asked Questions
DR. Martinoz Scholtz
The BS EN 1499 is a phase 2 step 2 quantitative suspension test. This test simulates practical conditions to check whether hand wash products are capable of inactivating transient microbial flora on artificially contaminated hands of volunteers.
The test applies to hygienic hand wash products designed to be used in areas where disinfection is medically indicated.
It takes 2-3 weeks to complete the test.
At Microbe Investigations Switzerland, we perform this test using the following microbial strains: Escherichia coli (ATCC 8739). Additional stains can be added at the customerโs request.
The effectiveness of hygienic handwash products is evaluated by contaminating the volunteersโ hands with E. coli. The number of bacteria released from the fingertips into sampling fluids is measured before and after handwashing with the test product. The reduction in microbial count indicates the product’s efficacy.
To pass this test, the mean reduction in the release of microbes achieved by the hygienic handwash with the product under test should be larger than that achieved by a specified reference hygienic handwash (unmedicated liquid soap).
Yes. The test can compare the efficacies of different handwashes by testing them under the same conditions and comparing their microbial reduction results.
Your test report provides information on the microbial counts before and after handwashing, the reduction in microbial load, and an evaluation of the product’s efficacy against the reference handwash.
Yes. The test results support product claims and regulatory compliance by providing scientifically validated evidence of the product’s antimicrobial efficacy.
Testing the product depends on regulatory requirements, product formulation changes, and quality assurance protocols. Regular testing is recommended to ensure continued compliance.
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