Disinfectants used in medical and veterinary settings for maintaining high levels of hygiene, should be tested for their effectiveness and safety. International standards such as EN 1040 plays an important role in providing this assurance by providing a standard method for rigorous testing of bactericidal efficacy of disinfectants. It is applicable to a wide range of products used across various sectors such as medical, industrial, institutional, food processing, domestic and veterinary among others. It is important for both manufacturers and consumers to have an understanding of EN 1040 certification as it can impact product development, regulatory compliance, and market entry.

What is the role of EN 1040 in product development?

EN 1040 standard is a benchmark for disinfectant manufacturers during the initial product development stages. Manufacturers can develop effective products by testing their products using EN 1040 standard throughout the process of development. This not only aids in compliance but also helps in optimizing the formulation for effectiveness against bacteria under various conditions and is necessary for gaining access for market entry.

Certification process

The disinfectant products must go through a series of steps to receive EN 1040 certification. This mainly includes testing the products to assess its bactericidal activity. Such testing will be done under strict lab conditions like specific temperatures, contact times, and mandatory bacterial strains that the protocol stipulates. All the supportive documents, the test procedure followed, and the results obtained after testing the product should be properly documented and passed on to the relevant regulatory bodies.

What role does antimicrobial testing laboratories play in EN 1040 certification?

The manufacturers need to test their products in certified laboratories where these labs are able to verify their effectiveness through very rigorous testing of the tested product using the protocols set out in the standard. This ensures that the test results are consistent and reliable.

What are the benefits of EN 1040 certification?

Consumer trust

• EN 1040 certification of disinfectant products builds trust in consumers. Certified products are verified for effectively killing bacteria thus leading to at least 5 log reduction in the bacterial count, which is an important criteria for products used in medical, food processing, and public health settings.

Competitive advantage

• Manufacturers can gain a competitive edge in the market by obtaining EN 1040 certification. Certification assures consumers that the products they use for sanitizing their surroundings are effective and safe. It also shows that the company is committed to maintaining high standards of quality and safety. This quality is important in markets where consumers require products that are certified to provide high levels of performance.

Regulatory and compliance aspects

Meeting European Standards

• Meeting compliance with EN 1040 test standard is often a requirement for the disinfectant products that are sold in the European Union. This compliance ensures that only products that meet the minimum efficacy and safety requirements are available for purchase within the market.

Effects on global markets

• Though EN 1040 is a European standard, its implications extend globally. Many countries look to established standards such as those of the EU as benchmarks. Therefore, products meeting EN 1040 standards are often more readily accepted in non-EU markets.

Keeping up with changes

• Companies should make sure to stay up to date with EN 1040 standard because these standards are periodically reviewed and updated. Regular monitoring and testing of disinfectant products can help manufacturers in maintaining compliance with regulatory bodies.

How can MIS help?

Microbial Investigations Switzerland (MIS) plays an important role in validating the efficacy of disinfectant products claiming bactericidal properties. As a specialized laboratory, we offer comprehensive testing and validation services that align with the EN 1040 standard requirements. 

We ensure to provide accurate and reliable results required for obtaining certification. Our expertise in microbial testing and the use of state-of-the-art technology streamline the testing process, from the initial consultation to the final reporting.

To learn more about our EN 1040 testing services, contact our experts here.