scope:

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants or 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 - with water. This document is applicable to a broad spectrum of viruses (Annex B) 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. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex F).