EN 13727-Bactericidal activity in medical area. Chemical disinfectants and antiseptics. UNE-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 (National Accreditation Entity).
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).
Basic price with four bacteria: consult to firstname.lastname@example.org.
Basic price with only one bacteria (any of them): consult to email@example.com.
Basic price: this correspond to only one test concentration chosen by the customer, one time of contact, and one condition (dirty, clean, high or low dirty, depending of the guideline) and one temperature. For more variables, consult. In the assay always must be included one active and one non-active concentrations that are chosen by the laboratory. Besides, the time and temperature that are mandatory according with the guideline must be included. The conditions of use must be selected by the customer.
If the customer select the three concentrations and two of them do not include one active and one non-active, the assay will not meet the requirement of the guideline. In this case, the laboratory must look for the active and/or non-active concentration, but the cost of the test will be increased (consult).