EN 14561: 2007. Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2).
Test accredited by ENAC (Spanish National Accreditation Entity), for standard mandatory microorganisms and additionals.
The test organisms used as required to determine the bactericidal activity three species of bacteria (Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus hirae). The test should be performed at a temperature of 20 mandatory and required 60 minutes. Optional extra temperatures provided they are not above 60 and optional additional times of 5, 15 or 30 minutes may be used. The test can be performed under clean conditions simulated or dirty conditions. The product should be tested at least three levels including the non - active interval and another in the active interval. The product is tested on surfaces frosted glass and bacterial viability by the dilution-neutralization method is evaluated. To consider the bactericidal product must demonstrate a log reduction of 5 in the number of viable bacteria.