EN 14347 for Product Developers
For new product developers, especially those in the disinfectant industry, understanding and implementing the EN 14347 standard is crucial. This standard outlines basic methods for testing the sporicidal efficacy of chemical disinfectants ensuring that products are effective against bacterial spores which are the common cause for various infections and contamination scenarios. For the manufacturers of disinfectants, understanding and adhering to EN 14347 guidelines is not just about compliance but also about ensuring the safety, efficacy, and marketability of disinfectant products.
Guidelines Overview
1. Scope
EN 14347 applies to chemical disinfectants and antiseptics intended to demonstrate sporicidal activity. The standard’s protocols are designed to evaluate whether these products can effectively kill bacterial spores under the defined test conditions.
2. Product applicability
The standard covers disinfectant products intended for use in:
- Agriculture (excluding those for crop protection)
- Domestic environments
- Food hygiene sectors
- Industrial and institutional settings
- Medical and veterinary applications
3. Definitions and terms
Key terms defined in EN14347 include:
- Sporicidal activity: The ability of a product to reduce the number of viable bacterial spores by a specified amount under defined conditions.
- Test organisms: The standard suggests Bacillus subtilis and Bacillus cereus as the mandatory test organisms.
- Log reduction: The standard requires at least 4 log reduction in viable spore count to consider a disinfectant to be effective.
4. Test Conditions and Methodology
The testing methodology is very important for compliance and the steps involved are
- Preparation of test suspensions: Standardized bacterial spore suspensions are prepared as per the test protocol.
- Application of the Disinfectant: The disinfectant is challenged with the spore suspension under controlled conditions including specified temperatures (usually 20°C) and contact times (30, 60, or 120 minutes).
- Assessment of Sporicidal Action: After exposure, an aliquot is neutralized and plated on growth media to determine the number of surviving spores thereby calculating the log reduction achieved.
Practical steps for incorporating EN14347 into disinfectant product development
Initial assessment
Begin by assessing your product’s formulation to determine its efficacy under conditions outlined in EN 14347. This initial step is crucial as it sets the stage for all subsequent testing and development activities.
Laboratory testing
Collaborate with accredited laboratories that have the expertise and equipment to conduct EN 14347 testing. Ensure that the laboratory understands your product’s specific needs and the regulatory requirements.
Iterative development
Based on the test results, you may need to adjust your product formulation. This continuous process of testing and modification is essential for achieving both efficacy and compliance.
EN14347 for product developers
Innovating with confidence
Compliance with EN 14347 for product developers helps to advance their product innovation with confidence and supported by the assurance that their disinfectants have proven sporicidal activity. This validation is essential mainly for products designed for use in high risk areas like hospitals and food processing plants where effective disinfection is very essential.
Addressing market needs
Compliance not only satisfies regulatory requirements but also addresses a critical market need for effective sporicidal agents, particularly in recent times where bacterial resistance is a growing concern.
Collaboration and compliance
Working with established microbiological testing laboratories that understand and can implement EN 14347, helps in accurately analyzing the sporicidal efficacy of products. These collaborations are essential for understanding the needs of compliance and ensuring that the product will perform as claimed.
For new product developers, EN14347 provides a structured and scientifically rigorous way to prove the sporicidal efficacy of disinfectants and antiseptics. By closely following these guidelines, developers can comply with legal and safety standards and also gain a competitive advantage in markets that depend on proven effectiveness.
To ensure your product meets these rigorous standards, consider partnering with Microbial Investigations Switzerland (MIS). MIS offers comprehensive disinfectant testing and validation services in compliance with industry standards. With the help of the latest advanced technologies and our team of experts, we are committed to provide our customers with the most accurate and reliable services.
To get a quote on EN14347 testing or for more information about our testing services, consult with our experts today
