EN 14562: 2007. Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of fungicidal or yeasticidal 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 required as mandatory to determine the fungicidal activity are Candida albicans and Aspergillus niger (syn. Aspergillus brasiliensis) and for yeasticidal activity Candida albicans. Other additional and optional fungi can be used. The test should be performed at a mandatory temperature of 20ºC and a mandatory time of 60 minutes. Additional optional temperatures can be used according to the manufacturer's recommendation provided they are not above 60ºC and optional additional times of 5, 15 or 30 minutes. The test can be performed in simulated clean or dirty conditions. The product should be tested at three concentrations levels including one in the non-active interval and another in the active interval. The product is tested on ground glass surfaces and fungal viability by the dilution-neutralization method is evaluated. To consider the product with fungicidal activity or yeasticidal must demonstrate a log reduction of 4 in the number of viable cells or fungal conidia.