26/30559658 DC

This standard 26/30559658 DC BS EN 18368 Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of virucidal activity on nonporous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2) is classified in these ICS categories:

• 11.080.20 Disinfectants and antiseptics

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant products 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 products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping – regardless if they are covered by the Medical Device Regulation [1] or not. Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods. This document is applicable for four methods of application of products for wiping and/or mopping: a) soaking any non-specified wipe or mop with product; b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop; c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation; d) pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops. In all types of application the water control has to be conducted with the standard wipe (5.3.2.17 a), because it is process or method control. The contact time for the water control is no longer than 5 min. This document does not apply to products that are sprayed on or used for flooding of surfaces, without wiping or mopping during the contact time. In this case, the methods of phase 2/ step 2 without mechanical action apply. The test-surface (5.3.2.16) was selected as a standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface. This document is applicable 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients. NOTE This method corresponds to a phase 2, step 2 test. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.