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Project

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

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
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previous edition(s)

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
2015-06

Order from Beuth Verlag

Contact

Dipl.-Ing.

Heike Moser

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2906
Fax: +49 30 2601-42906

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