Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area – Test method and requirements (phase 2, step 1)
|ICS Code (Disinfectants and antiseptics):||11.080.20|
This document specifies a test method and the minimum requirements for sporicidal activity of chemical disinfectant that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - 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 European Standard applies to products that are used in the medical area in the fields of instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. 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. 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. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".