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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 volunteersโ 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 estimated 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
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Abstract
EN 12791 is applicable to surgical handrub and handwash formulations that are intended 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.
Scope of products for testing
The EN 12791 test is applicable for testing the efficacy of surgical handrubs and handwash solutions that are intended for use in areas or situations where disinfection is medically necessary such as:
- Hospitals
- Community medical facilities
- Dental institutions
- Clinics of schools, kindergartens
- Nursing homes
- Also includes the laundries and kitchens supplying products to patients.
EN 12791 Test Conditions & Requirements
Subjects – 23 to 28 volunteers are required to perform the test analysis. It is important to ensure that volunteers’ hands should not have any abrasions or cuts.
Contact time – 60 seconds
Reference product – Propanol-1 (60%)
EN 12791 Test Method
- Before treatment with test product and reference product, 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 Standard
EN 12791 is a critical European standard for evaluating the efficacy of surgical hand disinfectants, ensuring they provide both immediate and long-lasting antimicrobial action under real-world conditions. Unlike general hand hygiene standards, EN 12791 is specifically designed for surgical settings where a high level of microbial reduction and sustained protection is essential to prevent surgical site infections. By adhering to this standard, manufacturers demonstrate that their product meets stringent, harmonized EU requirements, supporting regulatory approval, clinical acceptance, and effective infection control in high-risk medical environments.
Strengths of EN 12791 Test Method
- The EN 12791 test method mimics actual surgical hand disinfection conditions, providing practical relevance.
- It offers measurable data on microbial reduction to confirm the immediate and long-term effectiveness of a product.
- It facilitates comparative testing with a reference disinfectant, guaranteeing that new products satisfy established efficacy standards.
Conclusion
At Microbe Investigations Switzerland, we recognize the critical role of surgical hand antisepsis in infection prevention. Our EN 12791 testing services are designed to support manufacturers in validating the efficacy of their surgical hand rubs and hand washes, ensuring they meet the highest regulatory standards.
With advanced laboratory infrastructure and a team of skilled microbiologists, MIS delivers accurate and compliant results you can rely on.
Contact us today to learn how we can support your product development and compliance journey.
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 Switzerland, we test for EN 12791 using the transient microflora found on human skin.
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