Overview

This European Standard EN 14476 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. With regard to DIN EN 14476:2007-002, the following modifications have been made: a) scope has been expanded, for example, to products for textile disinfection; b) "Obligatory test conditions" were replaced by "minimum test conditions" (test temperatures and contact times can be chosen within limits) that have to be performed to pass the test. c) a modified method to test ready-to-use products in a higher concentration than 80 %, for example 97% has been added; d) addition of noroviruses as test viruses; e) modification of the parvovirus strain to Murine Parvovirus, strain Crawford, ATCC VR-1346 (previous Bovine parvovirus, strain Haden, ATCC VR-767); f) modification of the maximum test temperature for instrument disinfection to 70 °C; g) supplementation of an annex for statistical evaluation by biometrical evaluation of experimental approaches and for calculation of the reduction (C.2.2); h) references updated, amongst others, reference to the superordinate standards DIN EN 14885 and DIN EN 12353; h) editorial update. 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.

Document: references other documents

Responsible national committee

NA 176-03-06 AA - Chemical disinfectants and antiseptics in human medicine  

Responsible european committee

CEN/TC 216/WG 1 - Human medicine