EN 13624:2003

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

Publication date:   Jun 11, 2004

Scope

This European Standard specifies a test method and the minimum requirements for fungicidal or 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. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion - even if they are not covered by the EEC/93/42 Directive on Medical Devices.
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 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 1 test (see annex E).

Related legislation

Legislation related to this standard