In September 2025, SHAPYPRO will conduct a proficiency test in compliance with EN 1500:2013 standard, designed to validate the technical competence of laboratories in evaluating the bactericidal activity of disinfectants and antiseptics used for hygienic hand treatment. This proficiency test provides laboratories with the opportunity to strengthen their technical competence and demonstrate that their procedures meet the rigorous international standards governing disinfection methods in clinical and community settings.
The proficiency test will focus on the use of Escherichia coli K12 as a model organism, a safe and representative microorganism that enables the evaluation of the accuracy and consistency of the analytical procedures employed by laboratories. Through this proficiency test, SHAPYPRO will provide a technical and methodological framework that facilitates the intercomparison of results among participants, ensuring compliance with EN 1500:2013 standard and promoting quality in analytical processes.
Scope of EN 1500:2013 Standard
EN 1500:2013 standard establishes a standardized method for evaluating the bactericidal activity of disinfectants and antiseptics used for hygienic hand treatment by rubbing. This method simulates real-world conditions in settings such as hospitals, medical centers, nursing homes, industrial kitchens, daycare centers, and other environments where proper hygiene is critical to preventing the spread of infections.
The purpose of the standard is to determine whether the products used meet the established biocidal capacity criteria by comparing them to a 60% propan-2-ol reference solution. This standard serves as a benchmark to ensure that the methods used in the evaluation of disinfectants and antiseptics are technically valid and reproducible, enabling continuous improvement in the quality of analytical processes.
Hygienic hand treatment plays a fundamental role in reducing transient microbiota, consisting of microorganisms that can easily transfer between surfaces, individuals, or food. Therefore, the accurate evaluation of the biocidal capacity of disinfectants and antiseptics is essential to ensure safety in these settings and to enhance the technical competence of participating laboratories.
Escherichia coli K12 as a Proficiency Test Organism
Escherichia coli K12 is selected as a model organism in this assay due to its microbiological relevance and safety for participants. This strain, classified as non-pathogenic and low risk, is commonly used in microbiological assays due to its ability to provide reproducible and relevant results, including biocidal capacity assessment assays.
In the context of testing according to EN 1500:2013, E. coli K12 acts as a representative of the transient microbiota present on hands. Its use allows laboratories to accurately evaluate the methods used to determine the biocidal capacity of disinfectants and antiseptics under practical conditions.
The preparation of E. coli K12 bacterial suspensions is carried out under strict protocols that guarantee uniformity in the initial load of microorganisms. This homogeneity is essential to ensure that results obtained in different laboratories are comparable, thus allowing technical validation of analytical procedures. This approach allows the results obtained in different laboratories to be comparable, reinforcing the technical competence and ensuring the validity of the procedure.
Proficiency Test Methodology and Testing Conditions
The test follows the principles established in EN 1500:2013 standard, which outlines a rigorous protocol designed to guarantee the reproducibility and accuracy of results. The procedure begins with the preparation of bacterial suspensions and the recruitment of volunteers who will participate in the tests under controlled conditions.
First, the hands of the volunteers are uniformly contaminated with a suspension of E. coli K12, ensuring a homogeneous microbial load. Next, the disinfectant or antiseptic under evaluation is applied by rubbing, following a standardized protocol that specifies the product volume and contact time, which ranges between 30 and 60 seconds depending on the manufacturer’s specifications.
After treatment, microbiological samples are collected from the hands using validated techniques, allowing the determination of the number of viable microorganisms before and after the application of the disinfectant or antiseptic. This approach provides an accurate measure of the disinfectant’s biocidal capacity observed under testing conditions.
A critical component of the procedure is the use of a validated neutralizer, which halts the action of the disinfectant or antiseptic at the end of the specified contact time. The prior validation of the neutralizer ensures that it does not affect bacterial viability or introduce interferences into the results. Statistical tools like the z-score help confirm that the data obtained accurately reflect the biocidal capacity of the disinfectant under evaluation.
Requirements and Key Parameters
EN 1500:2013 standard establishes specific criteria that must be met during the test, contributing to the technical competence of participants. Among these is the comparison of the results obtained with the 60% propan-2-ol reference solution, which serves as the standard for evaluating the biocidal capacity of the disinfectant being tested.
According to the standard, for a disinfectant product to be considered effective, its biocidal capacity must not be inferior to that of the reference solution. The effectiveness of disinfectants and antiseptics is measured in terms of the logarithmic reduction of viable microorganisms.
The test is conducted at a controlled temperature of 20 ± 1°C, simulating real-world environmental conditions. Additionally, the contact time of the disinfectant must be adjusted to the manufacturer’s specifications, allowing for a representative evaluation of its performance under practical conditions.
Bacterial samples are cultured on appropriate media, and results are expressed in terms of the logarithmic reduction in the number of viable microorganisms. This analysis determines whether the methods employed by laboratories meet the technical and regulatory requirements established, using statistical tools like the z-score to verify the consistency of results.
Benefits of Participating in the Proficiency Test
Participation in this proficiency test organized by SHAPYPRO offers several significant benefits for laboratories. First, it allows participants to validate their analytical procedures in accordance with international standards, ensuring that their methods are technically competent and comply with the requirements of EN 1500:2013 standard.
Additionally, this proficiency test facilitates the identification of potential deficiencies in technical competence, enabling laboratories to implement improvements that enhance the quality of their internal processes. Inter-laboratory comparisons provide valuable insights into the consistency and reproducibility of results. A detailed z-score analysis helps identify areas for improvement and build confidence in the analytical services offered.
Another highlight is the issuance of a participation certificate upon completion of the test. This document supports the laboratory’s technical competence, increasing its credibility and reinforcing clients’ trust in the results obtained.
Why Trust SHAPYPRO
SHAPYPRO has over 10 years of experience in organizing proficiency tests and evaluating disinfectants and antiseptics in compliance with international standards. Its expertise and commitment to excellence position it as a recognized leader in this field, providing participating laboratories with comprehensive technical support throughout all stages of the proficiency test.
With tests designed to meet the requirements of ISO/IEC 17043 and other relevant standards, SHAPYPRO ensures that each exercise aligns with the most stringent quality standards.
Participation in a test organized by SHAPYPRO not only strengthens laboratories’ positions in the sector but also enables continuous improvement of their procedures, demonstrating their commitment to quality and technical competence.
For more information or to secure your spot in this proficiency test program, do not hesitate to contact us. SHAPYPRO is here to help you achieve your goals and ensure compliance with the highest standards in analytical evaluation.