EN 13727: 2012 + A2: 2015. Quantitative suspension test for the evaluation of bactericidal activity in medical area. Test method and requirements (phase 2, step 1).
Test accredited by ENAC (Spanish National Accreditation Entity), for standard mandatory microorganisms and additionals.
This test use as mandatory organisms Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus hirae, and besides Escherichia coli K12 for hygienic handwashing and handrub or Enterococcus faecium for the medical instruments disinfection. The test must be performed at a mandatory temperature of 20ºC. The time for the hygienic handwashing or handrub must be between 30 to 60 seconds; 1 to 5 minutes for surgical handwashing or handrub, ≤ 60 minutes for medical instruments disinfection; a maximum of 5 minutes for surfaces near to patients, and a maximum of 60 minutes for other surfaces. The test conditions can be clean or dirty, except for handrub that must be always clean condition and for hygienic handwashing that must be always dirty condition. The product can be tested under the dilution-neutralization method or by the membrane filtration method. To consider the product as bactericidal a 5 logarithm reduction in the viable number of bacterial cells must be obtained (or ≥ 3 log reduction for the hygienic handwashing products).