This standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products for instruments that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
This 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 kindergardens 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 (see Annex E)."