DS/EN 16615:2015

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)

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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”.

Number of pages: 42

Published: 2015-05-27

Date of approval: 2015-04-14

International relationships : EN 16615:2015 IDT

ICS: 11.080.20 - Disinfectants and antiseptics

Item number: M272812



  • CEN/TC 216
  • CEN/TC 216/WG 1

Danish committee