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BS EN 14348 : 2005
Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants (phase 2, step 1)
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Quick understanding of the test
BS EN 14348 : 2005 - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants (phase 2, step 1)
Application
- Mycobacterium avium
- Mycobacterium terrae
- The test sample is exposed to a suspension of test microbes and interfering substance and kept for specific contact times.
- After contact time, the test mixture is transferred to a neutralizing solution.
- Neutralizing extract is plated and incubated to enumerate remaining viable cells.
Benefits
- Ensures that disinfectants are potent against mycobacteria, significantly lowering the risk of cross-infections within hospital environments.
- EN 14348 evaluates products in simulated practical conditions, ensuring reliable efficacy.
Turnaround Time
- Mycobacterium avium: 4โ6 weeks
- Mycobacterium terrae: 3โ4 weeks
The disinfectant’s performance is determined by calculating the log reduction in bacterial colonies.
Passing criteria
The disinfectant must achieve a 4-log reduction in viable mycobacteria under specified test conditions.
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Abstract
EN 14348 specifies a test method that determines the mycobactericidal (or tuberculocidal) activity of chemical disinfectant products intended for use in the medical area.
Mycobacterial strains show resistance to disinfectants because of their complex cell wall structure. Such strains are a more common cause of cross-infections and are associated with severe complications in hospital settings. Disinfectants claiming to possess tuberculocidal and mycobactericidal properties are tested against objectionable strains to determine their efficacy.
EN 14348 Test Conditions & Requirement
- Mandatory test microorganisms –
For Mycobactericidal activity – Mycobacterium avium and Mycobacterium terrae
For Tuberculocidal Activity – Mycobacterium terrae
- Test temperature – 20 ยฐC
- Contact time – 60 min
- Log reduction – Tested product must achieve 4 log reduction value
- 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
EN 14348 Test Method
- Test sample is added into solution of test microorganisms and interfering substance. Mixture is allowed to interact for a specific duration.
- At the end of contact period, 1 ml of solution is further transferred into neutralizing solution to suppress bactericidal activity.
- Neutralizing extract is plated and incubated to enumerate remaining viable cells.
- After incubation, bacterial colonies are enumerated and results are compared to the control sample.
Conclusion
MIS carries out EN 14348 disinfectant efficacy testing that is compliant with the specific requirements of international standards.
With state-of-the-art technology and highly experienced experts, we are able to maintain high-quality services and yield more accurate results. Plus, we ensure to meet clients’ project requirements in a very timely manner.
Also, we have capabilities of performing EN 14563 disinfectant efficacy test.
For more queries related to our microbiology testing services, talk to our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 14348 test is phase 2 step 1 quantitative suspension test that determines mycobactericidal activity of chemical disinfectants intended for use in medical areas.
EN 14348 test is applicable for chemical disinfectants and instrument disinfectants to be used in areas or situations where disinfection is medically indicated.
Turnaround time for testing against Mycobacterium avium will be four to six weeks. While
testing against Mycobacterium terrae will take three to four weeks.
At Microbe Investigations Switzerland, we test for EN 14348 using the following microbial strains: Mycobacterium avium and Mycobacterium terrae.
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