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EN 12791 Surgical Hand Disinfection Efficacy Test
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Summary
ISO 846 testing is done to evaluate the resistance of plastics to microbial growth and biodeterioration under controlled laboratory conditions. This test helps plastic manufacturers understand material durability, surface contamination risks, and long-term performance in real-use environments. MIS lab performs ISO 846 testing to deliver reproducible data to support microbial resistance and material durability claims for compliance and product decisions.
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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 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
Passing criteria
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What is EN 12791?
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 EN 12791 standard
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 overview
Pre-wash Procedure Before Testing
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.
Pre-treatment Sampling (Baseline Count)
Then, fingertips are dipped into tryptic soy broth (TSB) to determine pre-values of viable bacteria present on the hands.
Product application and contact time
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.
Microbial enumeration
Conclusion is drawn by comparing the reduction in microbial counts from the hands treated with test handrub/handwash to the one treated with a reference product.
Understanding log reduction results
To pass EN 12791
- Immediate and 3-hour effects of product – product ≥ reference (60% v/v propan-1-ol)
- To claim sustained effect of products – 3 hours effect of the product > reference (60% v/v propan-1-ol)
EN 12791 vs EN 1500 vs EN 13727
Parameter | EN 12791 | EN 1500 | EN 13727 |
Purpose | To evaluate the effectiveness of surgical handrubs and handwash in reducing resident skin flora immediately and over a sustained period | To evaluate the efficacy of hygienic handrubs in reducing transient microbial flora on hands | To evaluate the bacterial efficacy of chemical disinfectants and antiseptics used in medical areas |
Test phase | Phase 2 step 2 | Phase 2 step 2 | Phase 2 step 1 |
Test organisms | Resident skin flora | Escherichia coli K12 | Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus hirae |
Scope of products | Surgical handrubs and handwash solutions | Hygienic handrubs used in hospitals, schools, dental institutions and nursing homes | Hygienic handrub, handash, surgical handrub, handwash, instrument disinfectants and surface disinfectants |
Passing criteria |
| Microbial reduction of product ≥ reference (60% v/v propan-2-ol) |
|
Why products fail EN 12791 testing
Products fail EN 12791 due to several reasons:
- Insufficient reduction of resident flora – EN 12791 compares a product’s antimicrobial efficacy against a reference alcohol (usually propan-1-ol). If the test product does not achieve an equal or greater reduction in the natural skin microbiota (resident flora), it fails.
- Weak sustained activity (especially at 3 hours) – A key requirement of EN 12791 is prolonged antimicrobial effect. After initial application, the product must continue suppressing microbial regrowth for up to 3 hours.
- Inconsistent application protocol – The test method is highly standardized, including defined contact time, volume, and application technique. Any variability can lead to inconsistent results and failure
- Formulation volatility or rapid evaporation – Products that evaporate too quickly may not maintain sufficient skin contact time. This reduces both immediate efficacy and residual action, making it difficult to meet EN 17291 performance criteria.
Regulatory relevance of EN 12791
EN 12791 test method is a critical requirement for supporting surgical hand disinfectant claims, as it generates validated evidence of efficacy against resident skin flora. It supports compliance with EU disinfectant regulations and is often necessary for the approval of products intended for use in hospitals and clinical environments. By meeting this standard, manufacturers can ensure their formulations deliver consistent and reliable infection control performance.
When should you choose EN 12791
Choose EN 12791 if your product:
- Is a surgical hand disinfectant
- Requires validation under european standards
- Needs proof of sustained antimicrobial activity
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.
Why choose MIS
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.
EN 12791 is specifically designed for surgical handrubs and evaluates both immediate and sustained reduction of resident skin flora on human volunteers, rather than just in-vitro microbial kill.
The reference product used in EN 12791 is 60% v/v propan-1-ol
This helps to ensure that product maintains prolonged antimicrobial activity under gloved conditions. This helps confirm that microbial regrowth is controlled throughout procedures.
It is not mandatory but is often expected by regulators for making surgical handrub claims under European regulatory frameworks.
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