NA 176

DIN Standards Committee Health Technologies

Standards [CURRENT]

DIN EN 16615
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German version EN 16615:2015

Title (German)

Chemische Desinfektionsmittel und Antiseptika - Quantitatives Prüfverfahren zur Bestimmung der bakteriziden und levuroziden Wirkung auf nicht-porösen Oberflächen mit mechanischer Einwirkung mit Hilfe von Tüchern im humanmedizinischen Bereich (4-Felder-Test) - Prüfverfahren und Anforderungen (Phase 2, Stufe 2); Deutsche Fassung EN 16615:2015

Overview

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. 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". 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  

Edition 2015-06
Original language German
Translation English
Price from 123.40 €
Table of contents

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