The EN 14348 standard, a European standard, describes the requirements and test methods for assessing the mycobacterial killing activity of chemical disinfectants used in medical devices.
This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 14348 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of myco bacteria killing effectiveness of chemical disinfectants used in the medical field, including device disinfectants - Test methods and requirements (step 2, step 1).
The test method described in this standard uses two test organisms (mycobacterium avium and mycobacterium terrae) for mycobactericidal activity and one test organism (mycobacterium terrae) for tuberculosis activity. The tests must be carried out at a mandatory temperature of 20 degrees and within a mandatory time of 60 minutes.
In addition, these tests are carried out optionally at additional temperatures of 10 degrees and additionally at 5, 15 or 30 minutes. Tests must be carried out in clean or dirty conditions.
Chemical disinfectants and antiseptics to be tested should be tested in at least three concentrations, one in the inactive range and the other in the active range. During the tests, dilution-neutralization method is applied.
Mycobacteria are more resistant to chemicals than vegetative bacteria and enveloped viruses due to the waxy layer that protects microbes. In addition, myco-bactericidal activity covers activity against all mycobacteria and is superior to tuberculosis activity.
Briefly, the EN 14348 standard describes the parameters to be followed when testing disinfectants, including equipment disinfectants intended for use in the medical field. These parameters are test microorganism, test temperature, contact time and compound substance.
TS EN 14348 Chemical disinfectants and antiseptics test services are also provided to our businesses within the framework of various laboratory services.
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.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
