EN 14347 is a European Standard which provides guidelines for evaluating if a product under development is capable of effectively eliminating resistant bacterial spores. By providing standard test methods and requirements, the EN 14347 test ensures that only products meeting a high standard of sporicidal activity are developed for use across various sectors including domestic, food hygiene, industrial, institutional, medical and veterinary fields.
What are the test conditions and requirements for the EN 14347 test?
- Test temperature and contact time: Use of a temperature of 20°C and contact times 30, 60 or 120 minutes is specified in EN 14347 standard.
- Mandatory test strains: The standard specifies the use of spores of Bacillus subtilis and Bacillus cereus for evaluating sporicidal activity.
- Passing criteria: A disinfectant should demonstrate a log reduction of at least 4 in the number of viable spores, to pass the EN 14347 efficacy criteria.
What is the EN 14347 test procedure?
- Preparing bacterial spore suspension – The first step involves preparing bacterial spore suspensions of the test organisms. Spores are cultured under conditions that promote their development followed by their isolation. The concentration of spores in the suspension is adjusted to ensure a consistent starting point for the test typically to a level where the suspension contains a known number of colony-forming units (CFU) per milliliter.
- Dilution of the test product – The product to be tested is prepared according to its intended use instructions or at a specified concentration. This preparation includes diluting the product with sterile water to achieve the desired test concentration ensuring it is representative of how the product would be used in a practical setting.
- Exposing spores to the test product – A measured volume of the spore suspension is added to the diluted test product. The mixture is then maintained at a temperature of 20°C (±1°C) for a contact time of 30, 60 or 120 minutes to evaluate the sporicidal activity of the product over different time periods.
- Neutralization and enumeration – Following the exposure period, an aliquot of the mixture is transferred to a neutralizing solution to stop the sporicidal activity of the test product. A series of dilutions of the neutralized sample is prepared and cultured on a suitable growth medium such as Tryptone Soya Agar (TSA) to allow any surviving spores to germinate and form colonies.
- Calculation of sporicidal activity – After an incubation period of 24 – 48 hours, the colonies formed from surviving spores are counted. The sporicidal activity of the test product is determined by comparing the number of viable spores before and after exposure to the product. A log reduction in the number of viable spores is calculated to quantify the product’s efficacy.
- Validating test conditions – To ensure the reliability of the test results, control tests are conducted alongside the main test. These include checking the neutralizing solution’s effectiveness, verifying the initial concentration of the spore suspension and conducting tests with known sporicidal and non-sporicidal agents to confirm the test system’s sensitivity and specificity.
- Reporting of results – The final step involves compiling and reporting the test results detailing the conditions under which the test was conducted, the sporicidal activity observed and any deviations from the standard procedure. This report provides a transparent and replicable record of the product’s efficacy against bacterial spores as determined under the guidelines of EN 14347 test.
What is the role of antimicrobial testing labs?
Antimicrobial testing laboratories test the disinfectant products according to the standard guidelines, under specified conditions to provide accurate and reliable results. Thus they play an important in evaluating the sporicidal activity of disinfectants.
MIS stands at the forefront of testing and validation services. With a deep understanding of the EN 14347 test and a commitment to excellence, MIS offers comprehensive testing services to validate the performance of disinfectants claiming sporicidal action. We aim to provide quality testing services to our clients by using cutting-edge technology thus ensuring accurate and reliable results.
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