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Calibration services in the frame of accredited coagulation EQA schemes - Meeting the IVD directive
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2006 (English)In: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 11, no 08-Sep, 451-454 p.Article in journal (Refereed) Published
Abstract [en]

Organisers of external quality assurance programmes may, for various reasons, also manufacture in vitro diagnostic medical devices, or provide calibration services. This paper describes measures taken by a Swedish organiser to meet the requirements of the European Commission's directive 98/79/EC for a national calibration of prothrombin time. Quality management system requirements and interactions with coagulation experts are summarised.

Place, publisher, year, edition, pages
2006. Vol. 11, no 08-Sep, 451-454 p.
Keyword [en]
in vitro diagnostic medical devices, calibration, external quality assessment, coagulation
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-45993DOI: 10.1007/s00769-006-0107-yOAI: oai:DiVA.org:liu-45993DiVA: diva2:266889
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2017-12-13

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Lindahl, Tomas

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