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EN 16437
Evaluation of the bactericidal activity of chemical disinfectants and antiseptics on porous surfaces
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EN 16437 - Evaluation of the bactericidal activity of chemical disinfectants and antiseptics on porous surfaces
Application
- Enterococcus hirae (ATCC 10541)
- Proteus vulgaris (ATCC 13315)
- Pseudomonas aeruginosa (ATCC 15442)
- Staphylococcus aureus (ATCC 6538P)
- Bacterial suspension with interfering substance is inoculated on a porous surface and allowed to dry.
- The dried test surface is exposed to a disinfectant sample for set time.
- The test surface is transferred to a neutralizing solution.
- The neutralizing extract is plated and incubated to enumerate the remaining bacteria.
- Supports regulatory compliance for disinfectants used in veterinary settings.
- Provide manufacturers with the data necessary to prove product efficacy and support regulatory submissions
Turnaround Time
Passing criteria
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Abstract
EN 16437 specifies a quantitative surface test (phase 2 step 2 carrier test) for disinfectant products utilized in veterinary areas. The test determines the bactericidal activity of product samples on porous surfaces. Notably, this method excludes mechanical action during testing, thereby assessing the intrinsic antimicrobial properties of a product under conditions that closely simulate real-world veterinary environments.
Scope of Application
EN 16437 is applicable to disinfectants that are used in the veterinary field for surface disinfection of porous surfaces without the use of mechanical actions in settings including:
- Breeding,
- Husbandry,
- Production,
- Transport and more.
Not applicable when animals are in the food chain following death and entry into the processing industry.
EN 16437 Test Conditions & Requirement
Mandatory test microorganisms – Enterococcus hirae (ATCC 10541), Proteus vulgaris (ATCC 13315), Pseudomonas aeruginosa (ATCC 15442), Staphylococcus aureus (ATCC 6538P)
Test temperature โ 10ยฐC
Contact time โ Between 1 minute and 60 minutes (in this range, contact times of 5, 15, 30, 60 and 360 min can be selected)
Interfering substance – 3g/l bovine albumin solution
Passing criteria โ Product must demonstrate >4 log reduction value
EN 16437 Test Method
- 10ul of bacterial suspension with interfering substance is inoculated on the surface of a poplar wood placed in a sterile petri dish and allowed to dry at 37ยฐC.
- The dried test surface is then exposed to sample products for specific contact time. After the contact time, the test surface is transferred to a new sterile petri dish and incubated for a specific time period.
- After the contact time, the test surface is transferred to a new sterile petri dish and incubated for a specific time period.
- In the next step, test surface is further transferred to a vessel containing a neutralizing solution. After vortexing for 15 seconds, the mixture is placed in a water bath at 20ยฐC for 25 minutes. Vessel is placed in an ultrasonic bath to remove bacteria from the test surfaces.
- Neutralizing solution is acquired, plated, and incubated to enumerate remaining bacteria.
- The number of viable microorganisms recovered is compared with the control to assess the efficacy of the disinfectant product.
Importance of EN 16437 Standard
Veterinary environments are complex ecosystems where pathogen transmission via porous surfaces poses serious risks to both animal and human health. Therefore, regular cleaning of critical surfaces in veterinary settings is a must to avoid the spread of pathogenic organisms. Efficacy testing of disinfectant/antiseptics products used in such settings is crucial to ensure that the cleaning practices meet the set benchmarks. Additionally, testing using this standard supports regulatory approvals for biocidal products, streamlining the registration and market entry process.
At MIS, we provide antimicrobial testing solutions to industries and clients around the world. We design protocols and execute antimicrobial efficacy tests for a wide range of disinfectant and antiseptic formulations.
In our lab, EN 16437 and EN 1656 are frequently requested and perform disinfectant testing for veterinary applications.
With deep industry expertise and cutting-edge competencies, we provide clients with reliable and responsive services.
For more detailed information on our EN 16437 testing services, contact our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 16437 specifies quantitative surface test to determine whether a given disinfectant and antiseptic product has bactericidal activity on a porous surface without mechanical action in the veterinary area. For a product to pass EN 16437 test, it must demonstrate a minimum of 4 log reduction value.
The test is applicable for chemical disinfectants and antiseptics designed for disinfection of porous surfaces in veterinary areas.
The test takes 2-3 weeks to complete.
At Microbe Investigations Switzerland, we test for EN 16437 using the following microbial strains: Enterococcus hirae (ATCC 10541), Proteus vulgaris, Pseudomonas aeruginosa (ATCC 15442), Staphylococcus aureus (ATCC 6538P)
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