EN 13624-Fungicidal activity in the medical area.UNE-EN 13624:2014. Chemical disinfectants and antiseptics.Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. Test method and requirements (phase 2, step 1).
Test accredited by ENAC (Spanish National Accreditation Entity).
This test uses as mandatory microorganisms Candida albicans and Aspergillus brasiliensis, for antifungal activity and Candida albicans for yeasticidal activity. The test must be performed according to the following minimal assay conditions depending of the intended use of the product: a) Handrub washing or hygienic handwashing: Assay strain Candida albicans; Temperature of assay 20ºC; Time of contact between 30 and 60 seconds; clean or dirty conditions. b) Surgical handrub or surgical handwashing: assay strain Candida albicans; temperature of assay 20ºC; time of contact between 1 and 5 minutes; clean or dirty conditions. c) Instruments disinfection: for antifungal activity strains of Aspergillus brasiliensis and Candida albicans; temperature of assay between 20ºC and 70ºC; time of contact not superior to 60 minutes; clean or dirty conditions. d) Surface disinfection: Aspergillus brasiliensis and Candida albicans strains; temperature of assay between 20ºC and 70ºC and time of contact not superior to 5 minutes (surfaces next to patients and/or health care personnel), and not superior to 60 minutes (for other surfaces); clean or dirty conditions. e) Additional conditions of assay: use of any other microorganism, independently of the intended use of the product; use of any interference substance for dirty condition, only with disinfectants for instruments and surfaces. The disinfectant product must be assayed at least at three concentrations including one in the non-active range and other in the active range (these last two concentrations are chosen by the testing laboratory). The disinfectant product can be assayed with the dilution-neutralization method, or with the membrane filtration method. To consider the product as fungicidal or yeasticidal it must show a 4-log reduction in the number of viable cell, except for products intended for handwashing that the log reduction can be 2. Important note: the disinfectant products can be assayed at a concentration equal or lower than 80%. Those products ready to use can be assayed at 97% concentration if they did not pass the test at 80% concentration. In case of disinfectants products intended for handwashing, 50% is the maximum concentration permitted. Customers must indicate in the submission form: 1) the use of the product; 2) the temperature of assay; 3) the conditions (clean or dirty); and the concentration/s of the product in the assay.