Ensuring that the biocidal products are compliant with EN 14347 standards is important for manufacturers to develop an effective disinfectant. EN 14347 is a European Standard that specifies the test method and requirements for the sporicidal activity of disinfectants to be used in various sectors including medical, domestic, food industries and veterinary areas. Adherence to this standard is an indication of the quality and efficacy of the product. This article will guide you through the important steps to ensure your biocidal products meet the EN 14347 criteria.
Steps to Ensure Your Biocidal Products Are EN 14347 Compliant
Meeting compliance with EN 14347 involves several steps which requires careful attention to the details and adherence to specific guidelines. The below mentioned steps serve as a guide to ensure compliance.
1. Evaluation of the product
Identify the scope of application
- Identify the specific applications of your biocidal product. Understanding if your product is intended for medical instruments, hard non-porous surfaces or skin surface helps with the relevant tests and requirements.
Assess active ingredients
- Assess the active ingredients in your product. The efficacy and safety of these ingredients are very important for compliance. Make sure that all active ingredients are approved and meet the biocidal product regulations (BPR) criteria.
2. Laboratory testing
Select an accredited laboratory
- Choose a laboratory which is accredited by regulatory bodies to perform EN 14347 testing. The laboratory should have a track record of conducting such tests and should be familiar with the details of biocidal product testing.
Parameter for testing
- It involves the selection of appropriate bacterial strains, preparing the test samples, and performing the test under specified conditions. Performing the test with high accuracy is important for valid results.
3. Documentation and reporting
Document the test results
- Collect all data and results for the laboratory tests. This includes gathering detailed information on the test methodology, bacterial strains used for testing, concentrations of the test samples, and conditions of the test.
Prepare compliance documentation
- Create a detailed documentation showing how your product meets the EN 14347 requirements. This should include the test results, assessment of the efficacy of the product, and any other relevant information.
4. Regulatory submission and review
Submit to regulatory authorities
- Send the compiled documents to relevant regulating authorities for review. This may include national health departments or European Union regulatory agencies depending on your market.
Address feedback
- Feedback or requests for additional information from regulatory authorities should be followed up promptly. Providing immediate and thorough responses can help fasten the review process.
5. Maintaining compliance
Regular review and testing
- Regularly review and test your product to ensure continued compliance with EN 14347 especially if there are changes in formulation or intended use.
Monitor regulatory updates
- Stay informed about any updates to the EN 14347 standard or related regulatory requirements. In case of any update, it might be necessary to make appropriate adjustments in your product or documentation to maintain compliance.
The role of antimicrobial testing laboratories
Professional testing labs offer several advantages like providing access to expertise, cutting-edge technology for testing antimicrobial products and also an understanding of the regulatory standards. These labs can help fasten the process of compliance with EN 14347 thus reducing the time and resources required by manufacturers to perform the same.
At Microbial Investigations Switzerland (MIS), we are specialized in testing and validation services for biocidal products. With a team of experienced professionals and a commitment to excellence, we provide the support and expertise necessary to achieve compliance, enhance product safety, and succeed in the competitive landscape of biocidal products.
To learn more about EN 14347 testing protocols and requirements or to receive a quotation, reach out to our experts here.
