DIN 58959-17:2011-03

If microbiological culture media, tests or procedures for the detection, differentiation and characterization of mycobacteria are used within the framework of medical diagnostics, they have to be checked for correctness on a regular basis. For this purpose control strains are used, among other things. This standard complements the standards DIN 58959-6 and DIN 58959-7 which regulate the use of control strains for bacteriology and mycology. Due to the slow growth as well as other phenotypic and genetic peculiarities of mycobacteria, the rules for fast-growing, non-mycobacterial bacteria or fungi are not readily sufficient for, or cannot be transferred onto, mycobacteria. Within the mycobacteria genus, tubercle bacilli are subject to biosafety level S3 and their handling requires certain safety measures to be taken. These peculiarities made it necessary to supplement the existing standards with regard to the requirements for control strains. These supplements are summarized in this standard. This standard applies to the handling of control strains of the mycobacteria genus. Control strains are used for the purposes of quality assurance. Thus, this standard is used in all mycobacteriological diagnostic laboratories in accordance with DIN 58956-1 or in laboratories in which equipment, culture media, reagents, test components, test kits and other diagnostic agents for the detection of mycobacteria are examined. The standard has been prepared by Working Committee NA 063-05-03 AA "Tuberkulose- und Mykobakteriendiagnostik" ("Diagnosis of tuberculosis and mycobacteria") of the Medical Standards Committee at DIN, the German Institute for Standardization e. V., in cooperation with the Arbeitskreis Mykobakterien (AKM) ("Working Group on Mycobacteria"). The AKM is a panel of experts based in the German-speaking area which, among other things, coordinates studies regarding mycobacteriological diagnostics.