BS EN 14561 specifies a carrier test for establishing whether a chemical disinfectant for use on instruments (surgical instruments, anaesthesia material, endoscopes etc.) has a bactericidal activity in the fields described in the scope. It includes general guidelines for the application and interpretation of test methods in accordance with European Standards for chemical disinfectants and antiseptics.
The laboratory test closely simulates practical conditions of application including pre-drying bacteria on a carrier, contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence the action of chemical disinfectants in practical situations.
The obligatory conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each utilization concentration of the chemical disinfectant found by this test corresponds to defined experimental conditions. However, for some applications the recommendations of use of a product may differ and therefore additional test conditions need to be used.
This European Standard specifies a test method and the minimum requirements for bactericidal 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 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, kindergartens and nursing homes
- that 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 which is covered by an Annex.
