EN 16615-Bactericidal activity and yeasticidal in medical area on non-porous surfaces. UNE-EN 16615: 2015 Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action in the medical area (4-field test). Test method and requirements (phase 2, step 2).
Test accredited by ENAC (National Accreditation Entity).
This test corresponds to test germ holder to establish whether a chemical and administered wipes, disinfectant with bactericidal and yeaticidal activities. The test product should form a physically stable homogeneous preparation when diluted with hard water, or distilled water for ready to use products. The product is used on nonporous surfaces, including the surfaces of medical devices, where disinfection is required (hospitals, community medical facilities and dental clinics, dispensaries schools, kindergartens and nursing homes, workplace and home; services such as laundries and kitchens supplying products directly to patients). It is applied by rubbing with tissues, using specific conditions of contact time, temperature and interfering substances, including predrying of the test microorganisms on the test surface used as germ holder and rubbing the product on the surface with a wipe. The wipes are soaked with 16 mL of product for 30 minutes, but the customer can choose other volumes and times soaked. The conditions are intended to cover general purposes, but may follow other recommendations for use of a product as additional test conditions. Likewise, it may be determined and additional specific bactericidal or yeasticidal activity applying other values of contact time and test organisms to take account of the specific conditions of use envisaged.
Assays may be performed under simulated clean conditions (bovine albumin solution 0.3 g/L) or dirty conditions simulated (bovine albumin solution 3.0 g/L + 3.0 mL/L of sheep erythrocytes) according practical application intended for the product. A temperature between 4°C and 30°C, a minimum contact time of 1 min and a maximum of 5 minutes, in the test four test organisms (for yeasticidal activity Candida albicans; for bactericidal activity Staphylococcus aureus, Enterococcus hirae and Pseudomonas aeruginosa) should be included or 60 min. Contact times for surface disinfectants are selected depending on the practical conditions of application of the product. The recommended contact time for use of the product is the responsibility of manufacturer. The products intended for disinfecting surfaces likely to come into contact with the patient and/or medical staff, and surfaces that are frequently touched by different people and involving the risk of transmission of microorganisms to the patient, must be tested using a contact time of 5 min as maximum. The same applies when the contact time of the product must be limited for practical reasons. Products for other surfaces than those indicated in this section can be tested with a contact time of 60 min at most. To be considered bactericidal, the product must demonstrate in the test field "1" at least one decimal logarithmic reduction of viable counts of bacteria (log10 R) of 5 (Staphylococcus aureus, Enterococcus hirae, Pseudomonas aeruginosa), and yeasticidal activity considered with a log reduction of 4 for yeast (Candida albicans). Mean CFU in the test fields "2" and "4" must be equal or less than 50, and the average of the CFU in the control of water should be less than 10.