Microbial efficacy testing has been growing and advancing with technological developments and increasing demands for standard safety procedures including the use of biocidal products. Among the various tests developed for biocidal efficacy testing, EN 14347 has been specifically created to analyse the sporicidal activity of various products.
This article talks in detail about EN 14347 explaining its origin, mandatory strains for testing, procedures, scope of products, and test conditions.
EN 14347
EN 14347 is a European Standard that specifies a test method and the minimum requirements for examining the sporicidal activity of chemical disinfectants that form a homogeneous physically stable preparation when diluted with water. Focused on initial phase 1 suspension testing of disinfectants under development, EN 14347 aims to confirm whether the disinfectant product can effectively kill dormant bacterial spores under specified conditions.
Origin and Development
This standard was developed by the Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” and it represents a collaborative effort to standardise the sporicidal testing methods across Europe. Its development was driven by the need for a reliable and reproducible method to evaluate the effectiveness of relevant disinfectants used in places with greater health risks.
Test Procedure and Requirements
The test method involves utilising bacterial spores of Bacillus subtilis and Bacillus cereus to validate the sporicidal activity of products. The procedure challenges disinfectant samples with spores of resistant test strains under specific conditions followed by quantifying the reduction in viable spores.
To get the EN 14347 test certification, the test product must lead to > 4 log reduction in spore viability.
Scope of products and applications
EN 14347 can be used to test the activity of sporicidal products which are under development and are intended to be used across various sectors including the agricultural sector, domestic sector, food & hygiene sector, industrial sector, institutional sector, medical sector, and veterinary sector.
The important role of EN 14347 testing
Spores are the dormant form of bacteria or fungi and they possess layers of protection that preserve their genetic material providing them resistance to harsh conditions such as heat, radiation, desiccation and chemical treatments. This resilient character facilitates the survival of spores even under harsh environments for a long period of time thus presenting challenges for sterilisation and disinfection processes.
These spores cause potential health risks as they are capable of germinating once the environmental conditions are favourable for their growth, thus creating a need for sporicidal disinfection. Sporicidal disinfectants are designed to effectively penetrate the protective layers of spores and eradicate the dormant cellular content thus neutralising their ability to germinate and multiply.
The standard testing and certification process under EN 14347 is not just regulatory requirements. They represent critical measures to ensure that biocidal products are truly effective against potentially dangerous spores thereby helping the manufacturers in finalising the formulations used for product development.
The significance and role of EN 14347 for Biocidal Efficacy Testing include:
Efficacy Verification: It explains a standard test procedure for evaluating the sporicidal activity of the disinfectants and ensures that they are efficient enough based on their performance.
Regulatory Compliance: Products are required to pass this test and be certified as sporicidal thus conforming to European standards and regulations
Product Development: Helps in the development and improvement of sporicidal agents by providing a benchmark for evaluating and comparing the effectiveness of different formulations.
Biocidal efficacy testing services offered by Microbial Investigations Switzerland (MIS)
MIS offers comprehensive biocidal efficacy testing and validation services that not only ensure compliance with EN 14347 but also help assist our clients in the development of more effective products. MIS applies its specialised knowledge to support manufacturers in achieving the rigorous standards set by EN 14347.
At MIS, we provide antimicrobial testing services for a wide range of products from various sectors and manufacturers globally including textiles, coatings, disinfectants and plastics. Our team of microbiology employs both standard and customizable approaches to meet the unique testing requirements of our clients.
To learn more about our testing services, pricing, and turnaround times, reach out to our expert team today.
