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 (National Accreditation Entity).
The test organisms used as mandatory organisms Candida albicans and Aspergillus brasiliensis to determine the fungicidal activity and Candida albicans for yeasticidal activity. The test should be performed in a minimum of test conditions, which depend on the use of the product: a) Hygienic treatment of hands by rubbing (handrub) or hygienic handwashing: test strain Candida albicans; test temperature 20ºC; contact time between 30 and 60 seconds; clean or dirty conditions. b) Surgical treatment of hands by rubbing (surgical handrub) or surgical handwashing: test strain Candida albicans; test temperature 20ºC; contact time between 1 and 5 minutes; clean or dirty conditions. c) Disinfection of instruments: for fungicidal activity Aspergillus brasliensis and Candida albicans; test temperature between 20 and 70ºC; contact time not exceeding 60 minutes, clean or dirty conditions. d) Surface disinfection: strains of Aspergillus brasiliesis and Candida albicans; test temperature not exceeding 5 minutes (close to the patient and/or health personnel surfaces), and not more than 60 minutes (to other surfaces); clean or dirty conditions. e) Additional Test conditions: addition of any organism, regardless of use of the product; incorporation of any relevant dirty test conditions, only for disinfection products for instruments and surfaces substance. The product should be tested at least at three concentrations including one in the non-active interval and another in the active range. The product can be tested by the method of dilution-neutralization method or by the membrane filtration method. To consider the product as fungicidal or yeasticidal must demonstrate a log reduction of 4 in the number of viable cells except for handwashing products that the log reduction could be less than 2. Important note: the product may be tested at a concentration equal or less than 80%. Products ready for use can be tested at 97% if not pass the procedure 80%. Products for hand washing, its maximum concentration in the assay is 50%.