EN 1500 and EN 1499 are European standards that assess the bactericidal efficacy of hand hygiene products, but they apply to different product types and answer different practical questions. For professionals in product development, quality, regulatory affairs, or infection prevention, understanding this distinction is crucial, not only for selecting the correct test, but also for designing claims, ensuring compliance, and building products that perform reliably in healthcare environments.
What is the difference between EN 1500 and EN 1499?
- EN 1500 is the European standard for hygienic handrub (alcohol-based rubs/gels). It measures bactericidal activity when a product is applied and rubbed in without rinsing.
- EN 1499 is the European standard for hygienic handwash. It simulates washing hands with water and a product, followed by rinsing and drying, and compares results to a reference handwash.
Similarities between two standards : EN 1500 and EN 1499
Both standards are phase 2, step 2 tests that use artificially contaminated human volunteers and quantitative recovery of bacteria from the hands. Theyโre not suspension tests; they employ practical, volunteer-based methods intended to reflect real use more closely than in-vitro tests.
Target strain – Both the test methods use Escherichia coli K12 as the challenge organism and rely on controlled contamination, sampling, and statistical comparison to a reference procedure.
Area of application – EN 1500 and 1499 are applicable to products which are used in medically relevant situations, such as hospitals, community healthcare settings, dental clinics, schools, kindergartens, nursing homes, workplaces, and kitchens engaged in patient care.
Differences in Methodology
EN 1500: Hygienic Hand Rub Testing
- Methodology: Volunteers contaminate their hands with a test organism, Escherichia coli, then apply a reference hand rub and the product under evaluation. The bacterial load on the hands is measured before and after application to find out the reduction in bacteria.
- Contact time: 30-60 seconds
- Passing criteria: The test product should demonstrate at least an equivalent or superior reduction in bacterial count compared to the reference product (60% propan-2-ol).
For more details, check EN 1500
EN 1499: Hygienic Hand Wash Testing
- Methodology: Volunteers’ hands are artificially contaminated with a test organism, usually Serratia marcescens, following which the hands are washed with the product under test using a standardized procedure. Remaining viable bacteria are counted after washing to determine the effectiveness of the product.
- Contact time: 30-60 seconds
- Passing criteria: The test product must achieve larger log reduction compared to the reference product
For more details, check EN 1499
In summary, EN 1500 and EN 1499 are two complementary benchmarks that explain how the various hand hygiene products should be evaluated. EN 1500 confirms the efficacy of waterless handrubs, while EN 1499 validates the performance of handwash formulations with soap and water. Put together, they provide a structured means for manufacturers, regulators, and healthcare teams to compare products, align claims with real-life use, and ensure each formulation is tested under conditions representative of its intended use.
How MIS can help you !
At MIS, we offer professional testing and validation of hand hygiene products to ensure safety and effectiveness. Our services involve testing against standards such as EN 1500 and EN 1499. We can help manufacturers and healthcare providers alike to prove the efficacy of hand rubs and washes against targeted microorganisms.
We also offer testing of hand scrub formulations via ASTM E1115.
Whether your products serve healthcare settings, food safety applications, or general public health environments, our testing services provide the scientific assurance you need.
Contact us today to learn how we can assist you in validating your hand rubs and hand washes for healthcare, food safety, and public health environments.
