EN 14563: 2009. Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area. Test method and requirements (phase 2, step 2).
Test accredited by ENAC (Spanish National Accreditation Entity).
This test uses two test organisms required for mycobactericidal activity (Mycobacterium avium and Mycobacterium terrae) and one test organism for tuberculocidal activity (Mycobacterium terrae). The method uses a suspension of mycobacteria in an interfering solution dried on a ground glass carrier, to be immersed in the disinfectant solution tested. The test should be performed at a mandatory temperature of 20ºC and for a mandatory time of 60 minutes. It can be used other optional shorter additional times of 5, 15 or 30 minutes. The test can be done under clean condition or dirty conditions. The product should be tested at least three concentrations including one in the non-active interval and another in the active interval. The product should be tested by the neutralization method. To consider mycobactericidal, the product must show a log reduction of 4 in the number of viable counts.