Abstract
Manufacturers support the concept of traceability. However, only a small number of the medically relevant measurands can be traced to the highest metrological order. In many cases, the measured substances are heterogeneous mixtures where traceability can be established only to either an international conventional reference measurement procedure or to a manufacturer's own in-house reference system. The traceability concept needs to be seen in the context that the results of medical laboratories are not an aim per se, but are meant to provide useful medical information to clinicians, and that pre- and post-analytical steps may also contribute significantly to errors. There is a need for the further development of suitable reference measurement systems, but in view of the multitude of tasks and limited resources, priorities need to be set.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
European Parliament (1988) Directive 98/79/EC of the European parliament and of the Council of 27 Oct 1998 on in vitro diagnostic medical devices. Off J Europ Com L 331/1 (7 December 1998)
International Organization for Standardization (2002) Metrological traceability of values assigned to calibrators and control materials (ISO FDIS 17511:2002). International Organization for Standardization, Geneva, Switzerland
International Organization for Standardization (2002) Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials (ISO FDIS 18153:2002). International Organization for Standardization, Geneva, Switzerland
CEN (1999) In vitro medical devices — measurement of quantities in samples of biological origin — presentation of reference measurement procedures (EN 12286:1999). CEN, Brussels, Belgium
CEN (1999) In vitro diagnostic systems — measurement of quantities in samples of biological origin — description of reference materials (EN 12287:1999). CEN, Brussels, Belgium
International Organization for Standardization (2000) Laboratory medicine — requirements for reference measurement laboratories in laboratory medicine (EN ISO 15195:2000). International Organization for Standardization, Geneva, Switzerland
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2004 Springer-Verlag
About this chapter
Cite this chapter
Völkert, E. (2004). Implementation of traceability — needs and perspective of the in-vitro-diagnosticum industry. In: De Bièvre, P., Günzler, H. (eds) Traceability in Chemical Measurement. Springer, Berlin, Heidelberg. https://doi.org/10.1007/3-540-27093-0_28
Download citation
DOI: https://doi.org/10.1007/3-540-27093-0_28
Received:
Accepted:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-43989-9
Online ISBN: 978-3-540-27093-5
eBook Packages: Chemistry and Materials ScienceChemistry and Material Science (R0)