EN 14347 establishes a test methodology to evaluate the sporicidal activity of disinfectants. It is a quantitative suspension test which plays a vital role in the early product development stages for ensuring that these products possess the necessary antimicrobial properties against spore-producing bacteria.
Why is EN 14347 testing important?
EN 14347 is a fundamental part of the registration process for disinfectants within Europe signifying the product’s efficacy against harmful bacteria. It specifies the manufacturing and performance criteria for disinfectants ensuring they meet the effectiveness standards required in various settings including medical, veterinary and food industries.
What are the test requirements?
- Mandatory test organisms: The standard mandates the use of Bacillus subtilis (ATCC 6633) and Bacillus cereus (ATCC 12826) as the test microorganisms to determine a product’s efficacy against resilient pathogens.
- Test temperature: The test should be conducted at 20°C to mimic room temperature conditions.
- Contact times: The contact times of 30, 60 and 120 minutes are specified by the standard to evaluate the disinfectant’s efficacy over different periods.
- Passing criteria: A disinfectant must demonstrate a log reduction of at least 4 in the number of viable spores, to pass the EN 14347 efficacy criteria.
What are the steps involved in the EN 14347 testing ?
- Test sample preparation: The test sample is prepared by adding a specified volume of the bacterial spore suspension to the disinfectant sample at the required concentration.
- Incubation: The test sample is then incubated at 20 °C for a predetermined contact time to allow interaction between the disinfectant and the bacterial spores.
- Neutralization: Immediately after the incubation period an aliquot of the test sample is transferred into a neutralizing solution. This step stops the sporicidal activity of the disinfectant ensuring that any change in the number of viable spores is due to the disinfectant’s activity during the contact time and not afterward.
- Cultivation and enumeration: The neutralized sample is then cultured on a suitable medium and incubated for a period (usually 4 – 7 days). During this incubation period, any surviving spores germinate and form colonies. The colonies are then counted to determine the number of viable spores that survived the disinfectant treatment.
- Calculation of log reduction: The effectiveness of the disinfectant is then quantitatively determined by calculating the log reduction in the number of viable spores compared to a control sample (treated with water or a neutral solution instead of the disinfectant).
How does EN 14347 testing impact public health?
The rigorous assessment of disinfectants and antiseptics through EN 14347 has profound implications for public health. By establishing a standardized method for evaluating sporicidal activity the standard plays an important role in ensuring the availability of effective disinfectants across various sectors.
What is the role of antimicrobial testing labs?
Antimicrobial testing laboratories play an important role in the EN 14347 validation process. They provide the expertise, equipment and environment necessary to accurately assess disinfectants claiming sporicidal activity. Through thorough testing these labs help manufacturers refine their products to meet the stringent requirements set by EN 14347 ensuring public safety and product efficacy.
At MIS, our expertise encompasses comprehensive microbiology testing for sanitizers, antiseptics, and surface disinfectants, serving a wide range of sectors such as human and veterinary health and include both domestic and institutional environments.
Equipped with advanced testing laboratories and a seasoned team of experts, MIS delivers in-depth testing solutions to ensure your products meet EN 14347 standard and additional essential standards with precision.
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