Orvosi in vitro diagnosztikai vizsgáló laboratóriumok tevékenysége és az európai uniós szabványok; alapismeretek

Translated title of the contribution: In vitro diagnostic medical testing laboratories and EU standards; Basic elements

Lóránd Debreczeni, Mátyás Fekete, Barna Vásárhelyi

Research output: Contribution to journalArticle

Abstract

In the "in vitro diagnostic testing medical laboratories" particular attention should be paid to the confidental and reliable operation as to 60-75% of the information for medical decisions are derived from laboratory tests. The high-quality laboratory work is based on the standards created by the national professional boards. Laboratories in Hungary (as any other country around the world) should comply with the various directives and/or standards set out requirements: MSZ EN ISO 15189:2013, MSZ EN ISO 22870:2006, MSZ EN ISO 15197:2013, Guide to the Expression of Uncertainty in Measurements (GUM), guidelines of the International Union of Pure and Applied Chemistry (IUPAC), etc. Special attention should be devoted to the quality of the work (internal and external quality assurance). Participation in proficiency testing (MSZ EN ISO 17043:2010) is a must, where the results are evaluated by statistical methods as defined by the ISO 13528:2005 standard. Some aspects are summarized how to select appropriate laboratory services.

Translated title of the contributionIn vitro diagnostic medical testing laboratories and EU standards; Basic elements
Original languageHungarian
Pages (from-to)333-344
Number of pages12
JournalLege Artis Medicinae
Volume24
Issue number7
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Medicine(all)

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