| Zugriffsnummer |
12295 |
| Dokumenttyp |
Konferenzartikel
|
| Peer Review |
unbekannt |
| Sprache |
Englisch
|
| Titel |
Accreditation of calibration laboratories for clinical chemical quantities |
| Autor(in); Institution |
Czaske, Martin; Q.32, Akkreditierung, PTB-Braunschweig
|
| Quelle/Jahr |
Métrologie 99 : actes des conférences = Métrologie 99 : proceedings:(1999), 580
- 583
|
| ISBN |
2-909430-88-X
|
| Verlag |
Nanterre: Mouvement Français pour la Qualité
|
| Konferenzangaben |
Le 9ème Congrès International de Métrologie: Métrologie 99, Bordeaux, 18-21, Octobre, 1999, France
|
| Freie Schlagworte |
laboratory accreditation ; calibration laboratory ; clinical chemical quantities ; traceability ; reference measurement laboratory |
| Zusammenfassung |
Since 1997, calibration laboratories for clinical chemical quantities in Germany have been accredited within the framework of the Deutscher Kalibrierdienst (DKD) on the basis of EN 45001 and EN 45003. It is the purpose of these accreditations to assure and prove traceability of the values assigned to reference materials on the basis of reference measurement procedures and/or reference materials of a higher order, as required by the European In-vitro diagnostic Medical Devices Directive. On the basis of the experience gained so far, the paper reports about the interpretation of EN 45001 with a view to applying its specifications as accreditation criteria in the field of clinical chemical quantities. Reference is made to the usage of metrological terms in clinical chemistry. The elements essential for the assessment of laboratories are treated and the concept adopted by the DKD is discussed. |
