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BS EN 14563: 2008
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Quick understanding of the test
BS EN 14563: 2008 - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area
EN 14563 is a phase 2 step 2 carrier test which evaluates the mycobactericidal and tuberculocidal efficacy of disinfectants used for medical instruments under simulated real-world conditions.
Application
- Mycobacterium avium
- Mycobacterium terrae
- Test suspension mixed with interfering substances is spread on sterile glass slides and dried.
- Slides are exposed to the disinfectant for the specified contact time.
- At the end of the contact time, slides are neutralized followed by plating and incubation to determine viable cells.
- Test specifically assesses the products for mycobactericidal or tuberculocidal activity.
- Supports healthcare facilities to reduce the risk of infection transmission by validating product efficacy.
Turnaround Time
Passing criteria
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Abstract
EN 14563 is a quantitative Phase 2, Step 2 carrier test used to evaluate the mycobactericidal or tuberculocidal activity of chemical disinfectants specifically designed for instrument disinfection in medical environments. EN 14563 closely simulates practical application conditions, including the pre-drying of mycobacteria on a carrier and employing interfering substances. Such parameters are critical, as they reflect real-world scenarios that may influence the performance of chemical disinfectants in clinical environments.
Mycobacteria are capable of surviving harsh conditions, including low-nutrient environments and exposure to many chemical agents. Their resistance highlights the need for rigorous disinfection protocols, especially for reusable medical instruments that may come into contact with mucous membranes or sterile body sites.
EN 14563 testing ensures that disinfectants claiming mycobactericidal or tuberculocidal properties can eliminate these resilient organisms, thereby helping prevent the spread of potentially life-threatening infections.
Scope of products for testing
EN 14563 standard is applicable to areas and/or situations where disinfection is medically indicated –
- hospitals,
- community care centres,
- dental care settings,
- nursing homes,
- and laundries and kitchens providing services directly to patients.
EN 14563 Test Conditions & Requirements
EN 14563 Test Method
- Test suspension is mixed with an interfering substance and spread onto sterile glass plates. Inoculated slides are allowed to dry out.
- Inoculated dried slides are kept in a container containing test products for a specific contact period time. In parallel, water (control sample) is challenged with test microorganisms.
- At the end of contact period, glass slides are further transferred into neutralizing solution.
- Neutralizing extract is plated and incubated to determine viable cells.
- After incubation, bacterial colonies are enumerated and results are compared to the control sample.
Importance of EN 14563 Test
To prevent the transmission of mycobacterial infections in hospital environments, medical instruments must be disinfected with products possessing tuberculocidal and mycobactericidal action.
European standard EN 14563 provides a quantitative carrier test for evaluation of the mycobactericidal activity of disinfectants under practical conditions. Evaluation test is carried out for manufacturer’s instrument disinfectant products to ensure efficacy against mycobacteria.
Conclusion
At MIS, we have a full range of antimicrobial efficacy testing services for a variety of antiseptic and disinfectant products. We do have an extensive team of microbiologists and technical experts to customize and run EN 14563 protocols.
Additionally, customers can send us their product samples for quantitative carrier tests like EN 14561 to check bactericidal efficacy of instrument disinfectants.
Our constant mission is to deliver accurate and reliable test results to our clients to help them understand and eliminate potential product risks.
To discuss quotation and turnaround time for EN 14563 test and other related queries, reach out to us today.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 14563 is a quantitative carrier test designed to assess mycobactericidal or tuberculocidal activity of chemical disinfectants intended for instruments in medical areas.
EN 14563 test is applicable to instrument disinfectants used in health care facilities.
EN 14348 is a quantitative suspension test (Phase 2, Step 1) that assesses mycobactericidal activity under ideal lab conditions. While EN 14563 is a quantitative carrier test (Phase 2, Step 2) that evaluates disinfectants under simulated real-world conditions.
EN 14563 test takes 3-4 weeks to complete.
At MIS, we test for EN 14563 using the following microbial strains: Mycobacterium avium and Mycobacterium terrae. Additional strains can be added on customerโs request.
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