BS EN 13624:2021 – Tracked Changes

BS EN 13624 provides stringent criteria for evaluating fungicidal and yeasticidal activities of disinfectants used in medical environments, including dental surgeries, nurseries, and nursing homes. This standard is essential for ensuring that disinfectants offer the highest level of infection control in settings where risk mitigation is critical.

Significance of BS EN 13624 for Disinfectants

BS EN 13624 is instrumental in verifying the effectiveness of disinfectants aimed at controlling fungal and yeast infections in healthcare:

• Public Health Assurance: This standard ensures that disinfectants can effectively manage pathogens like A. brasiliensis and C. albicans, vital for patient and staff safety.
• Regulatory Compliance: Adhering to BS EN 13624 is often necessary for products to be approved for medical use, facilitating market access.
• Consumer Confidence: Products meeting BS EN 13624 are trusted by healthcare professionals for their proven efficacy in critical environments.

Key Components of BS EN 13624 Testing

The testing outlined by BS EN 13624 ensures that disinfectants are evaluated under realistic conditions:

• Test Organisms: Employs fungi such as A. brasiliensis and yeast like C. albicans to simulate potential healthcare challenges.
• Testing Conditions: Assesses fungicidal and yeasticidal activities under both clean and dirty conditions to mimic real-world use.
• Interfering Substances: Tests are conducted in the presence of substances like erythrocytes and bovine albumin to replicate the complex biological environments found in medical settings.

BS EN 13624 Testing Procedure

BS EN 13624 specifies a detailed methodology for the reliable evaluation of medical disinfectants:

• Preparation and Application: Disinfectants are prepared according to the manufacturer’s instructions and applied in conditions that reflect their intended medical use.
• Contact Times: The standard defines specific contact times to assess both immediate and residual activities of the disinfectants.
• Performance Evaluation: Effectiveness is measured by the reduction of fungal and yeast populations, ensuring the disinfectants perform effectively when needed.

BS EN 13624 Test Report

A BS EN 13624 test report provides a detailed account of the fungicidal and yeasticidal efficacy, central to manufacturers and regulatory compliance:

Components of a BS EN 13624 Test Report

A BS EN 13624 test report is an essential document that details the results from the testing of fungicidal and yeasticidal activities of disinfectants used in medical environments. This report is critical for manufacturers, regulatory bodies, and healthcare providers, as it validates the efficacy of the disinfectant under rigorous testing conditions. The key components of this report include:

• Test Sample Identification: This section provides detailed information about the disinfectant tested, including its chemical formulation and the intended concentration for use. This ensures clarity and reproducibility of the test conditions.
• Test Organisms: Lists the specific fungi and yeasts used in the tests, such as A. brasiliensis and C. albicans. This ensures that the disinfectant is tested against a broad spectrum of pathogens relevant to its intended medical use.
• Testing Methodology: Describes the step-by-step procedures followed during the testing, noting any deviations from the standard protocols. This section also details the conditions under which the tests were performed, ensuring that the methodology is transparent and replicable.
• Results of Fungicidal and Yeasticidal Activity: Presents quantitative data on the effectiveness of the disinfectant in reducing pathogen levels. This data demonstrates compliance with BS EN 13624 standards and highlights the disinfectant’s capacity to manage microbial threats effectively.
• Conclusions and Recommendations: Offers an overall assessment of the disinfectant’s performance based on the test results. This section may include recommendations for product improvement or provide confirmation that the disinfectant complies with the required standards.

Interpreting Test Results: Criteria for Effectiveness

The effectiveness of disinfectants under BS EN 13624 hinges on their capacity to markedly reduce fungal and yeast populations. A significant reduction, typically of four logs or more, is mandated by the standard, signifying robust fungicidal and yeasticidal activity. This level of reduction is crucial for confirming the disinfectant’s potency.

Additionally, the effectiveness is evaluated based on how the disinfectant performs within the specified contact time, essential for real-world applications. Disinfectants must also prove effective under varied conditions, both clean and interfered, as stipulated in the testing protocols. This comprehensive assessment ensures the product’s reliability across different environmental challenges.

BS EN 13624 in Product Promotion

Compliance with the BS EN 13624 standard offers significant advantages for manufacturers of fungicidal and yeasticidal disinfectants, greatly enhancing their marketing strategies.

Gaining Competitive Advantage

In the competitive market of medical disinfectants, securing healthcare provider trust is essential. BS EN 13624 certification provides manufacturers with a critical edge, distinguishing their products from non-certified alternatives by:

• Quality Assurance: Adherence to BS EN 13624 demonstrates a commitment to superior quality, showing that products have undergone rigorous fungicidal and yeasticidal testing.
• Meeting Healthcare Needs: This certification meets the growing demand for effective and reliable infection control products, making certified items more attractive to health-focused professionals.
• Establishing Trust: Achieving BS EN 13624 certification enhances trust among medical professionals, fostering loyalty and encouraging repeat business by validating the products’ effectiveness against fungi and yeasts.
• Enhancing Market Position: Certification marks a product as reputable and high-quality within the healthcare industry, offering a significant promotional advantage.

Enhancing Product Credibility

Credibility is imperative in the industry of medical disinfectants, particularly where efficacy against fungi and yeasts is a major concern for users. BS EN 13624 certification strengthens the credibility of these products, boosting consumer confidence by:

Safety and Efficacy Validation: Certification under BS EN 13624 serves as proof that a product effectively eliminates fungal and yeast infections, having passed thorough and comprehensive testing.

Broad-Spectrum Antimicrobial Protection: Products certified with BS EN 13624 are recognized for their ability to combat a wide range of fungal and yeast pathogens, providing extensive protection.

Verification of Regulatory Adherence: Achieving BS EN 13624 certification demonstrates a product’s compliance with stringent health and safety standards, reassuring healthcare providers about its quality and effectiveness.

Advancing with BS EN 13624

As the demand for effective fungicidal and yeasticidal disinfectants grows, especially in response to emerging health threats, the significance of BS EN 13624 becomes increasingly paramount. Manufacturers adhering to this standard can guarantee that their products meet rigorous fungicidal and yeasticidal efficacy requirements, thereby maintaining a competitive advantage and bolstering public trust. This commitment to BS EN 13624 ensures that healthcare environments are equipped with the most reliable and effective disinfectants necessary for combating fungal and yeast infections effectively.

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