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

Ornemark, Ulf ; Nilsson, Elisabeth ; Nordin, Gunnar ; Egberg, Nils ; Lindahl, Tomas L. ; Hillarp, Andreas LU ; Stigendahl, Lennart and Fagerberg, Inger (2006) In Accreditation and Quality Assurance 11(8-9). p.451-454
Abstract
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.
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author
; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
assessment, external quality, in vitro diagnostic medical devices, calibration, coagulation
in
Accreditation and Quality Assurance
volume
11
issue
8-9
pages
451 - 454
publisher
Springer
external identifiers
  • wos:000240680000015
  • scopus:33747143076
ISSN
0949-1775
DOI
10.1007/s00769-006-0107-y
language
English
LU publication?
yes
id
09a6418b-408c-4e56-9146-4e2431216421 (old id 686143)
date added to LUP
2016-04-01 12:23:21
date last changed
2022-01-27 03:05:20
@article{09a6418b-408c-4e56-9146-4e2431216421,
  abstract     = {{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.}},
  author       = {{Ornemark, Ulf and Nilsson, Elisabeth and Nordin, Gunnar and Egberg, Nils and Lindahl, Tomas L. and Hillarp, Andreas and Stigendahl, Lennart and Fagerberg, Inger}},
  issn         = {{0949-1775}},
  keywords     = {{assessment; external quality; in vitro diagnostic medical devices; calibration; coagulation}},
  language     = {{eng}},
  number       = {{8-9}},
  pages        = {{451--454}},
  publisher    = {{Springer}},
  series       = {{Accreditation and Quality Assurance}},
  title        = {{Calibration services in the frame of accredited coagulation EQA schemes - Meeting the IVD directive}},
  url          = {{http://dx.doi.org/10.1007/s00769-006-0107-y}},
  doi          = {{10.1007/s00769-006-0107-y}},
  volume       = {{11}},
  year         = {{2006}},
}