BS EN 14561: 2006

Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area (phase 2, step 2)

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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)

EN 14561 is a phase 2, step 2 quantitative carrier test to determine the bactericidal activity of chemical disinfectants and antiseptics used for instrument disinfection in medical areas.

Application

Applicable to disinfectants used in hospitals, dental clinics, schools, and other healthcare-related settings.
  • 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

Turnaround Time

Typically, 1–2 weeks.
The efficacy of the disinfectant is determined by measuring the log reduction in bacterial count and compared to the control.

Passing criteria

A log reduction of ≥ 5 in microbial counts is required for the disinfectant to pass.

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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

MIS Labs
1. What is EN 14561 test?

EN 14561 is a quantitative suspension test to determine bactericidal activity of chemical disinfectants and antiseptics used in medical areas.

2. What are the Products that can be tested with EN 14561 test?

EN 14561 test is applicable for instrument disinfectants that are used in hospitals and other healthcare settings.

3. What is the Turnaround Time for EN 14561 test?

EN 14561 test takes 1-2 weeks to complete.

4. On how many microbial strains can your EN 14561 testing lab perform tests on?

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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