The EN 16615 standard, a European standard, describes the requirements for the bactericidal and yeasticidal activity of the products of chemical disinfectant products, which when diluted with hard water or, in the case of ready-to-use products, form a homogeneous, physically stable preparation with water, and a test method is defined.
This standard applies to products used in the medical field for wiping disinfection of non-porous surfaces, including the surfaces of medical devices, whether or not covered by the medical devices directive 93/42/EEC.
This standard covers ready-to-use wipes impregnated with a microbicidal solution.
This test method is applicable to areas and situations where disinfection is medically indicated. The most common environments are:
While testing, a test surface is marked with 5 squares of 5 × 4 cm with consecutive test areas. Test area 1 on the test surface is inoculated with a test suspension of bacteria or yeasts in a solution of interfering substances and dried. A wipe is wetted with the product sample as delivered or diluted with hard water, for ready-to-use products. The test surface is wiped with the moistened tissue across the four marked test areas, starting at the front of test area 1, rotating just after test area 4, and towards the starting point. Temperature, contamination and contact time are used as recommended by the manufacturer. At the end of the contact period, test organisms are removed from each test area with moist cotton swabs. The number of test organisms surviving in each sample is determined. The test is performed using pseudomonas aeruginosa, staphylococcus aureus, enterococcus hirae and candida albicans as test organisms.
Quantitative testing for the evaluation of bactericidal and yeasticidal activity on mechanically effective non-porous surfaces by using cloths in the medical field within the scope of EN 16615 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it has given for businesses in various sectors. method (4-field test) also provides services.
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