In the European standard EN 14561, the requirements for the virucidal 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, are described and a test method is defined.
The standard in question is valid for products used for disinfection of instruments by immersion in the medical field, although they are not covered by the EEC/93/42 directive for medical devices. This test method is applicable to areas and situations where disinfection is medically indicated. The most common environments are:
This test method also covers service areas such as laundry and kitchen that provide products directly to patients.
The test suspension of bacteria in a solution of interfering substances during the test is spread on a glass carrier. After drying, the carrier is immersed in the delivered product sample or diluted with hard water, for ready-to-use products. The carrier is held at 60 degrees for 20 minutes. At the end of this contact time, the carrier is transferred to a neutralizer containing glass beads. Bacteria should be separated from the surface by shaking. The number of surviving bacteria in each sample is determined and the reduction calculated. The test is performed using pseudomonas aeruginosa, staphylococcus aureus and enterococcus hirae as test organisms. Optional contact times and temperatures are included in the standard.
Where noted, additional specific bactericidal activity is determined by applying other contact times, temperatures, test organisms and interfering substances to take into account the specific intended use conditions. For these additional conditions, the concentration defined as a result may be lower than that obtained with the mandatory test conditions.
Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides quantitative carrier testing services for the evaluation of the bactericidal effectiveness of medical instruments within the scope of EN 14561 standard, with its trained and expert staff and advanced technological equipment.
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