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EN 14563 Test

Evaluate Mycobactericidal and Tuberculocidal activities of Instrument Disinfectants

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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 specifies a test method to assess the efficacy of instrument disinfectants against mycobacteria.  

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.

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.

EN 14563 Test Conditions & Requirements

  • Mandatory test microorganisms –
  1. Mycobactericidal activity – Mycobacterium avium and Mycobacterium terrae
  2. Tuberculocidal activity – Mycobacterium terrae
  • Test temperature  – 20 °C
  • Contact time  –  60 minutes
  • Interfering substance  – Clean Conditions: 0.3g/l bovine albumin solution and dirty condition: 3.0 g/l bovine albumin solution + 3.0 ml/l erythrocytes
  • Log reduction –  Product must achieve 4 log reduction value to pass EN 14563 test
EN 14563 Test Process

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.

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. 

FAQs

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 products where disinfection is medically indicated.

EN 14563 test takes 3-4 weeks to complete.

At Microbe Investigations, we test for EN 14563 using the following microbial strains: Mycobacterium avium and Mycobacterium terrae. Additional strains can be added on customer’s request.

Contact us for more information

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