Verification of in vitro medical diagnostics (IVD) metrological traceability: Responsibilities and strategies

Author:

Braga Federica,Panteghini Mauro

Publisher

Elsevier BV

Subject

Biochemistry (medical),Clinical Biochemistry,Biochemistry,General Medicine

Reference43 articles.

1. Traceability, reference systems and result comparability;Panteghini;Clin Biochem Rev,2007

2. Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement;Panteghini;Clin Chem Lab Med,2010

3. Directive 98/97/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;Off. J. Eur. Communities,1998

4. In vitro diagnostic medical devices — measurement of quantities in biological samples — metrological traceability of values assigned to calibrators and control materials;International Organization for Standardization (ISO) 17511:2003,2003

5. In vitro diagnostic medical devices — measurement of quantities in biological samples — metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials;International Organization for Standardization (ISO) 18153:2003,2003

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