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BS EN 12791: 2016
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Quick understanding of the test
BS EN 12791: 2016 - Chemical disinfectants and antiseptics - Surgical hand disinfection (phase 2, step 2)
Application
- The test is performed on the resident microbial flora of volunteers’ hands and not on specified test organisms.
- Volunteers’ hands are pre-cleaned, and initial bacterial counts are measured using tryptic soy broth (TSB).
- Test and reference products are applied for specified contact times, and microbial levels are measured immediately after application and at 3 hours intervals.
- Results are compared to the reference product (60% Propanol-1) to assess efficacy.
- Validates the effectiveness of surgical hand disinfectants in reducing microbial contamination.
- Ensures compliance with European standards for products intended for medical settings.
Turnaround Time
Passing criteria
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Abstract
EN 12791 is applicable to surgical handrub and handwash formulations that are envisioned to be sold in the European market. This test evaluates the antimicrobial efficacy against transient and resident microbial flora found on the skin of a human hand.
EN 12791 is a (phase 2, step 2) carrier test in which volunteers hands are exposed to the disinfectant product for a given exposure time. The number of transient and microbial flora on the hand is evaluated pre- and post-exposure to the product and in a similar manner volunteers hand is exposed to a reference control. Based on the decreased number of organisms post-exposure to the product in comparison to the reference control, a conclusive remark can be made for the test disinfectant.
EN 12791 Test Conditions & Requirements
Subjects – 23 to 28 volunteers are required to perform the test analysis. Important to ensure that volunteers’ hands should not have any abrasions or cuts.
Contact time – 1 to 5 min
Reference product – Propanol-1 (60%)
EN 12791 Test Method
- Before treatment with disinfectant and reference products, volunteer hands are washed as per universal hand wash procedure to get rid of transient flora, dirt, and other unwanted debris from the skin.
- Then, fingertips are dipped into tryptic soy broth (TSB) to determine pre-values of viable bacteria present on the hands.
- In the next step, test handrub/ handwash and reference products are applied onto the hands of volunteers. After the disinfection process, microbial enumeration is performed immediately after the contact time and also after a gap of 3 hours.
- Conclusion is drawn by comparing the efficacy of microbial reductions from the hands treated with test handrub/handwash to the one treated with a reference product.
Importance of EN 12791 Test
Role of surgical hand formulations is to reduce microbial contamination of hands, which subsequently minimizes the risk of contact transmission of pathogens. EN 12791 specifies test requirements and efficacy criteria for surgical handrub and handwash formulations that are intended to be used in areas/situations where disinfection is medically necessary.
To meet EN 12791 passing criteria, tested products must not fall below 60% in potency compared to the reference control.
Conclusion
Microbe Investigations offers a comprehensive range of testing services for chemical disinfectants and antiseptics.
Our antibacterial, antiviral, antifungal/yeasticidal testing services are available from formulation under development stages, ingredient analysis, through to the final product and market launch.
Our labs are highly specialized and well equipped to analyze, assess, and track records for product samples in terms of chemical composition and antimicrobial activity.
Looking for EN 12791 testing services or having more queries regarding our testing capabilities, reach out to us here.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 12791 is phase 2, step 2 carrier test used to evaluate the antimicrobial efficacy of surgical hand disinfection products such as handrub and handwash. Test method determines whether a given product eliminates the transient and reduces resident flora microbial flora on hands.
EN 12791 test is applicable for surgical hand rub and handwash products which are planned to be used in areas where disinfection is medically indicated. Major areas include hospitals, community medical facilities, dental settings, and in clinics of schools.
EN 12791 test takes 2-3 weeks to complete.
At Microbe Investigations, we test for EN 12791 using the transient microflora found on human skin.
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