Management of in vitro diagnostic medical device batch identification in clinical microbiology laboratories].

In Czech Republic, clinical microbiology laboratories are currently acredited in accordance with the ISO 15189 standard specifying requirements for quality management and tracing of diagnostic device batches used in individual (albeit partial) tests. At present, practically all laboratories are equiped with laboratory information systems containing detailed entries on all tests performed in processed samples. The article focuses on procedures and potential tools supporting the laboratory logistics of in vitro diagnostics with information systems to meet the requirements for tracing the utilized in vitro diagnostic devices related to the analyzed samples.

Citation

Vít Lokoc, T Látal. Management of in vitro diagnostic medical device batch identification in clinical microbiology laboratories]. Klinická mikrobiologie a infekc̆ní lékar̆ství. 2009 Dec;15(6):201-4

Mesh Tags

PMID: 20411625

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