DIN EN 14476:2015-12

This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products for instruments, surfaces or hands that form a homogeneous physically stable preparation when diluted with hard water - or in the case of ready-to-use products, that is, products that are not diluted when applied, - with water. Products can only be tested at a concentration of 80 % or less (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This document is applicable to a broad spectrum of viruses (see Annex A) and 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. It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum and interfering substance. However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment. This amendment amends the standard DIN EN 14476.2013 as follows: a) For the hygienic handrub and handwash method a test for virucidal activity against enveloped viruses with Vacciniavirus has been added; the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC with regard to medical devices has been added (Foreword and Annex ZA); c) the value of vn in C.1 has been corrected (0,001 instead of 0,0001). 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.