Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical action employing wipes or mops in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German and English version FprEN 16615:2024
Abstract
This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal 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 European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping - regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not. This European Standard includes ‘ready-to-use wipes‘ which are impregnated with a microbicidal solution. 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 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”.
Begin
2021-11-15
WI
00216142
Planned document number
DIN EN 16615
Project number
06302118
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
draft standard
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical action employing wipes or mops in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German and English version prEN 16615:2022
2022-12
Order from DIN Media
