Ensuring the efficacy of disinfectants and antiseptics used in the healthcare industry is important to prevent the spread of harmful bacteria. Amongst the many standards developed for the evaluation of bactericidal activity, EN 13727 for bactericidal products has become one of the cornerstones for the efficacy assessment of chemical disinfectants in healthcare institutions. This standard was developed by the European Committee for Standardization (CEN) and gives a framework for testing the bactericidal activity of products intended for use in medical and related fields.
EN 13727 for bactericidal products
EN 13727 for bactericidal products is a European Standard that specifies the methods and requirements for assessing the bactericidal activity of disinfectants and antiseptics. It is mainly applied to disinfectants meant for health institutions like hospitals, clinics, and laboratories where proper disinfection is crucial in preventing pathogens spread. The standard is focused on in vitro testing, meaning the efficacy of a disinfectant is tested under a controlled laboratory environment to obtain reliable and reproducible results.
Scope of EN 13727
EN 13727 for bactericidal products applies to chemical disinfectants and antiseptics used in various sectors, with paramount importance in the health sector. The standard is applicable to products used for:
- Hand disinfection: It involves the application of products for hand hygiene in health institutions.
- Surface disinfection: Products that disinfect surfaces likely exposed to either patients or healthcare workers.
- Instrument disinfection: Products designed to disinfect medical instruments and equipment.
The standard specifies that to pass the test, a disinfectant must exhibit at least a 5 log reduction in the bacterial count under specified conditions mentioned in the standard.
Importance of EN 13727 in Healthcare
Healthcare settings are a high-risk environment for bacterial contamination. Disinfectants used in healthcare must be potent against a large number of bacteria which can be represented by harmful pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli. EN 13727 for bactericidal products defines a standard method to ensure they meet stringent bactericidal requirements. This test ensures healthcare workers that the product they rely on for effective disinfection works as intended and helps avoid the spread of hospital-associated infections (HAIs).
Important considerations for test procedure outlined by EN 13727
- Test bacteria selection: According to EN 13727, the following bacteria should be used for the test: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Enterococcus hirae. These microorganisms are representatives of the most common healthcare-associated pathogens and hence included in the test.
- Test solutions preparation: The test disinfectant or antiseptic is prepared according to the instructions given in the manufacturer’s guidelines. It is then diluted to the concentration at which it will be used in healthcare settings.
- Exposure time or contact time: This is the stipulated duration or recommended amount of time the bacteria is exposed to the disinfectant. The EN 13727 for bactericidal products suggests testing for different contact times to assess how quickly the disinfectant can reduce bacterial numbers. The contact time usually ranges from 30 seconds to 60 minutes depending on the product and surface to be disinfected.
- Neutralization: After the contact time, the disinfectant is neutralized, and the remaining bacteria are cultured to determine the reduction in bacterial numbers.
Criteria for passing EN 13727
According to EN 13727 for bactericidal products, an antiseptic/disinfectant has to achieve a minimum of 5-log reductions (99.999%) in the viable count of test bacteria within the specified contact time. Products that fulfill this requirement are considered to have sufficient bactericidal activity for use in healthcare environments.
How EN 13727 supports regulatory compliance!
EN 13727 supports regulatory compliance by assessing the bactericidal activity of the product in a standardized manner. By providing standard guidelines for testing, it enables reliable and accurate testing of products. These test results are reproducible and can be replicated across other testing laboratories. This allows manufacturers to compare their test results to ensure the effectiveness of their product before aiming for market approvals.
Benefits of EN 13727 testing
The EN 13727 for bactericidal products offers several advantages for both the manufacturers of disinfectants and healthcare institutions where these products are used.
For manufacturers: Manufacturers can easily increase their product credibility in a highly competitive market by meeting the rigorous criteria of this standard. Compliance with EN 13727 proves that the product is effective against tested bacteria. This makes it easier to receive regulatory approvals and marketing authorizations, particularly in the European Union. Compliance confirms the manufacturer’s commitment to quality and safety which is an essential factor while marketing their products to healthcare providers.
For healthcare institutions: The EN 13727 certification for disinfectants and antiseptics also ensures that healthcare institutions are using highly effective and rigorously tested products to ensure a safe and clean environment, thus minimizing the risk of hospital-acquired infections (HAIs). Compliant disinfectants also simplify the auditing process during regulatory inspections as healthcare facilities must demonstrate the use of effective products to meet their own regulatory requirements. Hospitals or clinics can rest assured that by choosing EN 13727 tested products they are investing in solutions that contribute toward safer patient outcomes.
EN 13727 vs. other disinfection standards
Although EN 13727 is no doubt the most applied standard in the field of bactericidal activity evaluation, it is not the only one. Other relevant standards, like EN 13697 for the assessment of bactericidal and fungicidal activity on non-porous surfaces and EN 14561 for the evaluation of bactericidal activity in medical devices are also equally important in specific contexts. However, EN 13727 is mainly focused on the bactericidal activity of disinfectants used in healthcare settings therefore, it is a very relevant point of reference during the evaluation of products intended for use in hospitals and other medical environments.
At Microbe Investigations Switzerland, we specialize in testing healthcare products according to the EN 13727 test standard. With our expert insights and precise methodologies, ensure your products meet the highest standards of efficacy and safety, protecting both patients and healthcare environments from harmful bacteria.
To learn more about our EN 13727 testing services or to schedule a consultation, please contact our specialists today.
