European Norms (EN) are standards which specify requirements, guidelines, or processes to ensure quality, safety, and efficiency of products/services. These standards are important as they establish recognized levels of quality and safety for products and processes, facilitating trade, ensuring product compatibility, and improving consumer safety.
EN 14347 is a phase 1 suspension test that specifies the test method and requirements for assessing the basic sporicidal bactericidal activity of chemical disinfectants and antiseptics. Specifically, it targets products intended for use across a wide range of settings that include agricultural, domestic, industrial, institutional, and medical areas.
This article talks about the science behind the EN 14347 test method and its implications to enable a comprehensive understanding of its importance, methodology, and impact on both industry practices and consumer safety.
The science behind EN 14347 standard
The EN 14347 is built upon a foundation of microbiological and chemical principles. The standard outlines specific test methods that assess the efficacy of disinfectants against spores produced by bacteria including both gram-positive and gram-negative bacterial strains.
- Microbiological principles
The EN 14347 standard is based on the principle of measuring the sporicidal activity of disinfectants. It considers factors such as how bacteria resist disinfectants, the effect of organic matter, and how different types of bacteria react to these cleaning agents. The standard uses specific bacteria, such as Bacillus subtilis and Bacillus cereus, as test organisms to assess if a product can effectively neutralize the spores under set conditions.
- Chemical principles
Chemically, the standard recognizes the different ways through which disinfectants exert their sporicidal effects. It considers how these chemicals interact differently with spore structures, creating a system that can handle various chemical types and how they work.
What are the steps involved in EN 14347 testing?
EN 14347 provides a standard method for evaluating the effectiveness of disinfectants. This method involves preparing bacterial suspensions, applying the disinfectant, and then calculating the reduction in the number of viable spores.
- Preparing the test suspensions
Bacterial spore suspension is added to the disinfectant at the required concentration to create the test sample.
- Incubation
The test sample is incubated at 20 °C for a predetermined time to allow disinfectant-spore interaction.
- Neutralization
An aliquot of the incubated test sample is transferred into a neutralizing solution to stop the sporicidal activity of the disinfectant.
- Cultivation and enumeration
The neutralized sample is cultured on a suitable medium and incubated for 4 – 7 days. This allows surviving spores to germinate and form colonies. After incubation, colonies are counted to determine the viable spore count.
- Calculation of log reduction
Logarithmic reduction in viable spores is calculated and compared with the control sample to determine the effectiveness of the disinfectant.
What are the impacts of EN14347 standard?
The EN 14347 standard has a significant impact on public health, regulatory compliance, and the development of disinfectants. This standard assists in the selection of effective products for applications in healthcare, agriculture and beyond by establishing a clear standard for sporicidal efficacy. It also leads to innovation in disinfectant technology leading to the development of more effective and safer products.
EN 14347 compliance and safety
Manufacturers need to thoroughly test and check the quality of their products to comply with EN 14347. They must work with accredited laboratories to validate their product’s sporicidal efficacy while following the specified methodologies and requirements. This confirms the products are safe and effective, meet regulatory standards, protect public health, and uphold industry norms.
What role do Antimicrobial Testing Labs play?
Antimicrobial testing laboratories are important for evaluating if disinfectant products work as expected according to EN 14347 guidelines. These labs act as a link between manufacturers and regulatory agencies. They make sure that products meet the required standards and thus help promote both innovation and safety while developing new products.
Microbial Investigations Switzerland (MIS) stands at the forefront of microbial testing, offering comprehensive testing and validation services that adhere to EN 14347 standards. With our cutting-edge technologies and a team of dedicated professionals, our constant approach is to provide accurate and reliable results to our valuable clients.
To know more about EN 14347 testing protocols or to request a quote, contact our experts here.
