In 2025, a proficiency test will evaluate the bactericidal activity of disinfectant products in the medical field, using Enterococcus hirae as the reference organism, following the EN 13727:2012+A2:2015 standard. This test targets laboratories that work with antiseptics and disinfectants in medical applications, meeting the necessary requirements for disinfecting hands, surfaces, and instruments.
EN 13727:2012+A2:2015 Standard
The EN 13727:2012+A2:2015 standard, widely recognized across the European medical sector, sets a quantitative suspension method for assessing the bactericidal activity of chemical disinfectants in the medical area. This test ensures that disinfectants meet efficacy standards in hospitals, clinics, and laboratories, where minimizing infection risk is paramount.
The scope of this standard includes critical applications, such as surface disinfection by wiping or spraying, instrument immersion in disinfectant solutions, and surgical and hygienic handwashing. EN 13727:2012+A2:2015 defines the criteria and methods for evaluating bactericidal efficacy against bacteria known for their role in nosocomial infections, like Enterococcus hirae (ATCC 10541). Additional test organisms included are Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa.
Enterococcus hirae as a Test Organ ism
The gram-positive bacterium Enterococcus hirae is frequently used in proficiency testing due to its significance in hospital infections. This model organism is suitable for evaluating the bactericidal activity of disinfectants, especially in environments where disinfection is key to infection prevention. Disinfectants effective against E. hirae fulfill medical standards for safety and efficacy.
Test Conditions for Enterococcus hirae According to EN 13727
EN 13727:2012+A2:2015 specifies conditions to ensure accuracy and reproducibility of bactericidal tests, aligned with real clinical scenarios. These conditions include variations in cleanliness (clean and dirty conditions) and the contact time and temperature of the disinfectant with the bacteria.
- Clean Conditions: To simulate clinical environments free from organic contamination, a bovine albumin solution at 0.3 g/L is used. This condition represents situations where visible residues have been removed before disinfectant application.
- Dirty Conditions: Here, organic matter presence is simulated with a mixture of bovine albumin (3.0 g/L) and erythrocytes (3.0 mL/L), representing high-contamination scenarios, such as cleaning surfaces in contact with bodily fluids.
For E. hirae testing, the temperature can range between 20°C and 40°C, depending on the product, with contact times varying from 1 to 60 minutes depending on the application. Shorter times are generally used for rapid-action disinfectants, such as those applied for handwashing.
Test Methods for Enterococcus hirae Compliance with EN 13727
The standard prioritizes the dilution-neutralization method, which stops the disinfectant’s antimicrobial activity after the contact time, ensuring results reflect the efficacy within the specified timeframe.
This method requires prior validation of the neutralizing agent to ensure it does not interfere with the viability of E. hirae or the disinfectant’s activity. This step is crucial for accurate and reliable product efficacy results. When neutralization is not viable, membrane filtration can be used, which retains the microorganisms for subsequent counting and evaluation of bacterial reduction achieved.
Efficacy Requirements
To meet the EN 13727:2012+A2:2015 standard, disinfectant products must demonstrate a 5-logarithmic reduction in the colony-forming units (CFU) of Enterococcus hirae, equivalent to a 99.999% bacterial population elimination. This level of efficacy is essential for critical care areas in clinical settings, where pathogen elimination is vital to patient safety.
Participate in Our Proficiency Testing
Starting January 25, 2025, the proficiency test will follow EN 13727:2012+A2:2015 guidelines to evaluate disinfectants against Enterococcus hirae. Participating laboratories will prepare a bacterial suspension exposed to the disinfectant under controlled conditions, with variables such as contact time and temperature adjusted as per the standard.
The proficiency test has multiple objectives that are crucial to ensuring quality and technical competence of the participating laboratories:
- Compliance with Accreditation Requirements: The test will enable laboratories to meet EN ISO/IEC 17025 requirements, which mandate regular proficiency testing programs to ensure technical co mpetence within the accreditation scope.
- Identification of Technical Issues: Laboratories can identify any issues in their testing methods and take corrective actions to enhance precision and reliability.
- Increased Client Confidence: Participating laboratories will receive a certificate validating their competence, providing clients with greater confidence in the services offered.
The disinfectant product (Alkyl (C12-16) dimethylbenzyl ammonium chloride) for testing will be supplied by SHAPYPRO, and a detailed protocol will be provided, specifying testing conditions such as contact time, temperature, and clean or dirty conditions. This protocol will allow laboratories to perform tests under standardized conditions that mirror practical situations in which disinfectants are used.
Alkyl (C12-16) dimethylbenzyl ammonium chloride
The test will have two stages:
- Effective Concentration Determination: Participating laboratories will calculate the minimum concentration of disinfectant needed to achieve the required reduction in E. hirae.
- Reduction Rate Determination: Once the effective concentration is established, laboratories will assess the reduction rate of the disinfectant under the conditions prescribed by the standard (based on contact time and temperature).
This proficiency test is designed for laboratories meeting the following profiles:
- Laboratories accredited under EN ISO/IEC 17025.
- Laboratories in the accreditation process looking to improve technical competence in disinfectant evaluation.
- Laboratories seeking ongoing performance monitoring to ensure consistency and quality in their results.
Additionally, SHAPYPRO ensures that the organization and processing of results are conducted according to applicable international standards, such as ISO/IEC 17043, ISO 5725, and ISO/IEC Guide 35, ensuring comparability and validity of results across participating laboratories.
For more information on this proficiency test or participation requirements, feel free to contact us at SHAPYPRO.
Why Choose SHAPYPRO’s Proficiency Tests?
With over 10 years of experience in evaluating the efficacy of disinfectant products, we offer proficiency testing programs that comply with the requirements of ISO/IEC 17043 and conform to EN 14885:2022/AC:2023.
We are the only accredited provider worldwide in this field of testing under ISO/IEC 17043. [Click here to download the accreditation]
Our extensive knowledge allows us to assist clients in developing new methods and R&D projects. We have previously developed proficiency testing programs under EN 13727.
Additionally, we are manufacturers of soft diluted soap necessary for both developments.
We provide customized proficiency tests. All tests are conducted in accordance with internationally validated standards and guidelines.
Interested in our 5-year schedule? Contact us!