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BS EN 1499: 2013 – Chemical Disinfectant and Antiseptics. Hygienic Handwash (phase 2, step 2 test)
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 manufacturer’s 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 manufacturer’s 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 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.
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.
FAQs
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 customer’s request.
The effectiveness of hygienic handwash products is evaluated by contaminating the volunteers’ 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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