DIN EN 16615:2015-06

This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water. This European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping - regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not. This European Standard includes 'ready-to-use wipes' which are impregnated with a microbicidal solution. This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities and in dental institutions; - in clinics of schools, of kindergartens and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. This method corresponds to a phase 2, step 2 test. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations". The committee responsible for this standard is NA 063-04-07 AA "Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin" ("Chemical disinfectants and antiseptics in human medicine") at DIN.