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Calibration services in the frame of accredited coagulation EQA schemes - Meeting the IVD directive

På svenska

Author

  • Ulf Ornemark
  • Elisabeth Nilsson
  • Gunnar Nordin
  • Nils Egberg
  • Tomas L. Lindahl
  • Andreas Hillarp
  • Lennart Stigendahl
  • Inger Fagerberg

Summary, in English

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.

Publishing year

2006

Language

English

Pages

451-454

Publication/Series

Accreditation and Quality Assurance

Volume

11

Issue

8-9

Document type

Journal article

Publisher

Springer

Topic

  • Medicinal Chemistry
  • Clinical Medicine

Keywords

  • assessment
  • external quality
  • in vitro diagnostic medical devices
  • calibration
  • coagulation

Status

Published

Research group

  • Clinical Chemistry, Malmö

ISBN/ISSN/Other

  • ISSN: 0949-1775