The EN 14348 standard, a European standard, describes the requirements for the mycobactericidal (or tuberculocidal) activity 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 defines a test method. Products can only be tested at 80 percent concentration or less because some dilution is always produced by adding test organisms and interfering substances.
This standard applies to products used in the medical field, including those 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 method defined in the EN 14348 standard is intended to determine the effectiveness of commercial formulations or active substances under the conditions in which they are used.
When performing the test, a test suspension of mycobacteria in an interfering agent solution is added to the product sample that is delivered or diluted with water for hard water ready-to-use products. The mixture is kept at 20 degrees for 60 minutes. At the end of this contact period, some of it is removed. Mycobactericidal or mycobacteriostatic activity in this section neutralized or suppressed immediately by some method. The number of surviving mycobacteria in each sample is determined and the reduction calculated. The test is carried out using mycobacterium avium and mycobacterium terrae or mycobacterium terrae alone as test organisms.
Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides quantitative suspension testing services for the evaluation of mycobactericidal effectiveness of chemical disinfectants in the medical field, including instrument disinfectants within the scope of EN 14348 standard, with its trained and expert staff and advanced technological equipment. .
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
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