- Swiss testing laboratory
BS EN 1500: 2013
Hassle-free testing experience
Need to get a product tested? No worries! To and fro logistics are on us; we collect your products, test them and, deliver them back to you.
Summary
EN 1500 is a phase 2, step 2 test used to evaluate the performance of hygienic hand rubs under practical use conditions. This standard measures a product’s capability to reduce transient microorganisms on artificially contaminated hands by comparing the performance with reference formulation. This helps demonstrate effective hygiene in healthcare and other medical settings.
Related tests for you
Quick understanding of the test
BS EN 1500: 2013 - Chemical disinfectants and antiseptics — Hygienic hand rub — Test method and requirements (phase 2/step 2)
Application
- Escherichia coli K12
- Volunteers’ hands are pre-washed to remove impurities and then immersed in a microbial suspension until dry.
- Fingertips are dipped into tryptic soy broth (TSB) to establish pre-contamination levels of viable bacteria.
- Hands are then rubbed with a sample of the handrub product for a predetermined contact time.
- After the contact time, fingers are immersed in a neutralizing solution to recover any remaining viable bacteria.
- A small sample of the neutralizing extract is plated and the bacteria are enumerated.
- Provides a standardized test to evaluate the efficacy of hygienic hand rubs in reducing transient microorganisms.
- The test simulates real-world usage conditions, making the results highly relevant and practical.
Turnaround Time
Passing criteria
Do you have a product that needs testing?
What is EN 1500?
The EN 1500 is an important test used to determine the efficacy of hygienic hand rubs. These products are tested to validate their effectiveness in high-risk areas such as hospitals, clinics, and other healthcare settings. EN 1500 evaluates whether hand rub products can significantly reduce transient microorganisms on users’ hands helping reduce the risk of infection spread.
EN 1500 Test Method Conditions & Requirements
The test method evaluates the efficacy of hand rub products under simulated practical conditions. The standard specifies the following conditions and requirements for testing:
- Mandatory test organisms
The primary organism used in testing is Escherichia coli K12.
- Subjects
The test requires 18-22 volunteers whose hands must be free of abrasions and cuts.
- Contact times
The contact time for the hand rub product ranges between 30-60 seconds or as recommended by the manufacturer.
- Reference product
Propan-2-ol (Isopropyl alcohol, IPA) is used as the reference product at 60% concentration by volume.
EN 1500 Test Procedure
Pre-wash
- Volunteers wash their hands with non-antimicrobial soap and water, then dry them with sterile paper towels.
Contamination
- Hands are immersed in an E. coli suspension for 5 seconds and then air-dried for 3 minutes.
Baseline sampling (initial value)
- Fingertips are rubbed over the base of the thumb of the other hand in a standard manner for 30 seconds using sample liquid (neutralizer + TSB). The sampling liquid is then pipetted into a sterile container.
Application of test product
- The test product is applied according to the manufacturer’s instructions, ensuring thorough coverage and rubbing for a specified time, usually 30 seconds.
Post-treatment sampling (immediate value)
- Immediately after rubbing, the baseline sampling process is repeated.
Incubation and enumeration
- An aliquot of the sample is taken, neutralized in a specified volume of neutralizing solution, plated onto TSA plates, and incubated at 36±1°C for 24±2 hours, followed by the counting of microbial colonies.
Reference procedure
- This procedure is repeated using the reference product (60% v/v propan-2-ol) with the same volunteers.
Neutralization and control
- Proper neutralization of the test product must be ensured by including neutralizer effectiveness controls.
Acceptance criteria
- The test product should demonstrate at least an equivalent or superior reduction in bacterial count compared to the reference product.
Benefits of EN 1500 certification for manufacturers
- EU Market Access & Regulatory Compliance – EN 1500 is one of the widely accepted European standard for hygienic hand rubs. Passing this test helps show compliance with European performance requirements and support market entry across the EU and other regions that recognize EN 1500.
- Achieving Brand Credibility- Independent EN 1500 testing validates that your hand rub effectively reduces transient microorganisms on human hands. This gives healthcare professionals, regulators, distributors and customers greater confidence in the product.
- Competitive Market Advantage – By comparing the test product performance against a standard reference alcohol formulation under real-use conditions, this test helps the product stand out from others that lack validated efficacy data.
- Supports formulation optimization- EN 1500 testing helps R&D teams optimize formulations of hand rubs by assessing product volume and application time. The results help identify the conditions needed to achieve the required efficacy levels.
EN 1500 vs EN 1499
Parameter | EN 1500 | EN 1499 |
Purpose | To evaluate the bactericidal efficacy of hygienic hand rubs (alcohol-based hand sanitizers) | To evaluate the bactericidal efficacy of hygienic hand wash products (soaps and hand washes) |
Mandatory test strains | Escherichia coli K12 (NCTC 10538) | Escherichia coli K12 (NCTC 10538) |
Test phase | Phase 2 step 2 | Phase 2 step 2 |
Scope of products | Hygienic hand rubs intended for healthcare and other medical settings where hand disinfection is performed without water | Hygienic hand wash products intended for healthcare and other medical settings where hands are washed with water |
Passing criteria | The product must achieve a significant microbial reduction equivalent to or greater than 60% propan-2-ol under test conditions | The mean microbial reduction achieved by the test product must be greater than that of the reference product (unmedicated liquid soap) |
Common Reasons Products Fail EN 1500 test
There are several reasons why products fail EN 1500. Some of them include:
- Insufficient antimicrobial efficacy – The formulation does not achieve microbial reduction equivalent to or better than the reference alcohol formulation required by EN 1500.
- Packaging integrity issues – Damaged or poorly sealed containers can lead to alcohol evaporation or contamination during shipping and storage.
- Testing aged or degraded samples – Products tested after extended storage or beyond their recommended shelf life may no longer meet EN 1500 performance requirements.
- Inadequate application volume – During testing, using an application volume that is lower than required can impact the effectiveness of the product, hence results.
- Insufficient contact time – The product requires a longer rubbing time than the claimed instructions to achieve the required efficacy.
How can MIS help?
At Microbe Investigations Switzerland (MIS), the EN 1500 hand rub testing is performed by experienced professionals using advanced analytical techniques. Compliance with this test standard demonstrates that hand rub products are effective under practical conditions and help reduce the infection spread.
For more information about our EN 1500 testing services or to request a quote, connect with our experts at MIS today. Ensure your hand rub products meet the highest standards of efficacy and safety with our comprehensive testing solutions.
Frequently Asked Questions
DR. Martinoz Scholtz
The EN 1500 test simulates practical conditions to evaluate if hygienic hand rubs effectively eliminate transient microflora when used on artificially contaminated hands of volunteers.
The test applies to hand rub products used in hospitals, community medical facilities, dental settings, clinics of schools, kindergartens, and nursing homes.
The test takes 2-3 weeks to complete.
At Microbe Investigations, we perform the EN 1500 test using Escherichia coli (ATCC 8739). Additional strains can be added upon customer’s request.
This test is a European standard specifically developed for hygienic hand rubs. Unlike other tests focusing on different pathogens or conditions, this test quantifies the log reduction of transient microbial flora on hands under simulated real-life conditions. EN 1500 is unique as it involves human volunteers, ensuring effective performance in actual usage scenarios.
To pass, a hand sanitizer must demonstrate a statistically significant reduction in microbial flora comparable to a reference solution of 60% propan-2-ol, achieving effectiveness under the test conditions.
The test is primarily designed for alcohol-based hand rubs, the most commonly used hand sanitizers. While other formulations can be tested, they need comparison against the standard reference solution of 60% propan-2-ol, which may not always be relevant for non-alcohol-based products.
Testing should be conducted at the initial development and formulation stage. Re-testing may be necessary in case of substantial formulation changes or processes. Periodic testing ensures continuous compliance and effectiveness, especially during regulatory reviews or market audits.
Common reasons for failure include insufficient alcohol content, poor formulation, weak application method, or incorrect volume usage during testing. Production fluctuations or ineffective dispersion of active ingredients can also lead to failure.
To prepare, ensure the product has the appropriate alcohol concentration (typically 60-95% ethanol or isopropanol). Conduct thorough pre-testing to verify efficacy, adhere to precise formulation and production standards, and consult experts in microbiological testing. Conducting pilot studies can help identify and rectify potential issues before formal testing.
Meet the best of the blend of
R&D, Efficacy Testing,
Innovation and Passionate
Experts at MIS.
Explore More
Key Takeaways EN 13727 and
Key Takeaways EN 1040 is
Key takeaways EN 1276 is
Antimicrobial testing is important to
Antibacterial efficacy testing is an
