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BS EN 14561: 2006
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Quick understanding of the test
BS EN 14561: 2006 - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area (phase 2, step 2)
Application
- Pseudomonas aeruginosa (ATCC 15442)
- Staphylococcus aureus (ATCC 6538P)
- Enterococcus hirae (ATCC 10541)
- A bacterial suspension mixed with an interfering substance is inoculated on sterile frosted glass and allowed to dry.
- The dried glass is exposed to the disinfectant for a specific contact time.
- After exposure, the sample is neutralized using a neutralizing solution.
- The neutralizing extract is plated and further incubated to enumerate viable bacterial colonies.
Benefits
- Provides measurable outcomes through log reduction calculations.
- Aids manufacturers in improving their antibacterial formulations and ensuring market readiness.
Turnaround Time
Passing criteria
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Abstract
EN 14561 test method is used to determine bactericidal activity of chemical disinfectants and antiseptics intended for instrument disinfection in medical areas. This test is applicable to products used in areas and/or situations such as hospitals, dental clinics, workspaces, houses, and clinics of schools.
Test conditions and test requirements
- Mandatory test microorganisms – Pseudomonas aeruginosa (ATCC 15442) and Staphylococcus aureus (ATCC 6538P) and Enterococcus hirae (ATCC 10541).
- Additional strains tested at MIS – Escherichia coli (ATCC 8739), Klebsiella pneumoniae (ATCC 4352), MRSA (ATCC 33591), Salmonella enterica (ATCC 10708), Candida albicans (MTCC 3017). Additional strains can be added on request.
- Test temperature – 20 °C
- Contact time – 60 min
- Interfering substance
Clean conditions – 0.3 g/l bovine albumin solution
Dirty conditions – 3.0 g/l bovine albumin solution and 3.0 ml/l erythrocyte
- Log reduction – ≥ 5
EN 14561 Test Method
- Bacterial suspension with an interfering substance is inoculated on the surface of a sterile frosted glass.
- Inoculated surface is then allowed to dry out.
- In next step, dried inoculated glass is transferred to product sample for a specific duration of time.
- At the end of contact time, glass is further transferred to the neutralizing solution.
- 1 ml of neutralizing extract is plated and incubated for 2 days.
- After incubation, bacterial colonies in test samples are enumerated and results are compared to the number of bacterial colonies present on control sample.
Conclusion
At MIS, we have expertise in designing both standardized and customized methods which are in line with international standards to evaluate the antimicrobial efficacy of instrument disinfectants used in medical areas.
We also perform EN 1276 for evaluation of bactericidal efficacy of disinfectants used in food, industrial, domestic and institutional areas.
For pricing-related queries on the EN 14561 test method, please contact our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 14561 is a quantitative suspension test to determine bactericidal activity of chemical disinfectants and antiseptics used in medical areas.
EN 14561 test is applicable for instrument disinfectants that are used in hospitals and other healthcare settings.
EN 14561 test takes 1-2 weeks to complete.
At Microbe Investigations, we test for EN 14561 using the following bacterial and fungal strains: Pseudomonas aeruginosa (ATCC 15442), Escherichia coli (ATCC 8739), Staphylococcus aureus (ATCC 6538P), Enterococcus hirae (ATCC 10541), Klebsiella pneumoniae (ATCC 4352), MRSA (ATCC 33591), Salmonella enterica (ATCC 10708), Aspergillus niger (ATCC-16888), Candida albicans (MTCC 3017).
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