DIN EN 1500:2013-07

This European Standard EN 14476 specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers. Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub for use in 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 can also include services such as laundries and kitchens supplying products directly for the patient. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations". This method corresponds to a phase 2, step 2 test. This standard differs from DIN EN 1500:1997-10 as follows: a) the method of the statistical evaluation has been changed. The number of volunteers has been slightly increased to achieve the same confidence level as before; b) validation of the neutralization has been added; c) structure and wording of the standard have been brought in line with other CEN/TC 216 standards. 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.