Understanding EN 1040 standard is crucial for manufacturers of disinfectants and sanitizers which are intended to be used in various sectors. The EN 1040 specifies a quantitative suspension test that is used for evaluating the bactericidal efficacy of active ingredients in the disinfectants. Since maintenance of cleanliness and hygiene is very important in areas such as food sectors, industrial, domestic, and hospital settings among others, having sound knowledge of this standard can help manufacturers develop products that are highly effective and safe to use at the same time. This article is structured to provide manufacturers with a detailed guide on EN 1040 test standard, procedure to perform the test and its significance.
What is EN 1040?
EN 1040 is a phase 1 suspension test, which evaluates the bactericidal activity of disinfectants and antiseptics. This standard helps to ensure that products marketed with bactericidal claims meet a baseline level of efficacy against specific bacterial strains under controlled laboratory conditions.
What is the scope of application for EN 1040?
EN 1040 standard is applicable to chemical disinfectants which are in an early stage of development. This test is applicable to disinfectants being developed for use in the following sectors:
- Food and catering industries
- Domestic and institutional areas
- Medical and veterinary sectors
This wide range of applications makes it an important standard for ensuring public health and safety in various settings.
What is the importance of EN 1040?
Understanding and implementing EN 1040 standard is important for:
Product development
- Helps manufacturers develop effective bactericidal products.
Quality control
- Assists in the quality assurance process within various industries.
Regulatory compliance
- Ensures compliance with various European health and safety regulations.
What are the test conditions and requirements?
The standard specifies the exact test conditions under which the tests should be conducted to ensure consistency and reliability.
- Mandatory test organisms- The standard mandates the use of Pseudomonas aeruginosa (ATCC 15442) and Staphylococcus aureus (ATCC 6538P) as the test microorganisms to determine a product’s efficacy.
- Test temperature- The test should be conducted at 20°C to mimic room temperature conditions.
- Contact times- A contact time of 5 minutes is specified by the standard to evaluate the disinfectant’s efficacy.
- Passing criteria- A disinfectant must demonstrate a log reduction of at least 5 (99.999% kill) in the number of viable bacteria, to pass the EN 1040 efficacy criteria.
How is the EN 1040 test carried out?
- Preparing test solutions
- Dilute the disinfectant to concentrations up to 80% of its original strength.
- Ensure the solutions are mixed well and stable under test conditions.
- Inoculation and exposure
- Challenge the disinfectant test sample with a known amount of bacterial suspension.
- Maintain exact volume and concentration ratios as specified.
- Incubate the test sample at 20°C for a contact time of 5 minutes to test disinfectant efficacy.
- Neutralization and recovery
- Stop the disinfectant action immediately after incubation by adding a neutralizing agent.
- The choice of neutralizer must be appropriate for the disinfectant and validated to not harm bacteria.
- Enumerating viable organisms
- Quantify the number of surviving bacteria after neutralization, using the plate count method.
- Calculating bactericidal activity
- Calculate the reduction in bacterial numbers.
- A minimum 5-log reduction (99.999% kill) indicates that the disinfectant passes the test.
What is the role of antimicrobial testing labs?
Antimicrobial testing laboratories play a critical role in executing EN 1040 standard. These labs ensure the accuracy and reliability of the results through rigorous testing protocols and validation of methodologies. By providing these services, testing labs help manufacturers adhere to regulatory standards, optimize product formulations, and maintain the efficacy of their antimicrobial products.
At MIS, we specialize in extensive microbiology testing for sanitizers, antiseptics, and surface disinfectants, catering to various industrial sectors. Our state-of-the-art laboratories and experienced team of professionals provide thorough testing solutions to ensure your products comply with the EN 1040 standard.
To receive a quote for EN 1040 testing or for more information related to any other services, contact us today.
