In November 2000, NIST hosted a workshop on Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Devices. One of the driving forces was the new European Community (EC) In Vitro Diagnostic Devices (IVDD) directive that requires traceability of IVD devices to recognized national standards. By December 2003, all IVD products sold in Europe must have the EC Mark verifying compliance with the directive. U.S. manufacturers are major exporters of IVD products and thus are directly impacted by this directive. NIST/CSTL worked closely with the workshop cosponsors, NCCLS, AACC, AdvaMed (formerly HIMA), CDC, and College of American Pathologists (CAP) to ensure that the needs of the IVD industry were presented and met. The workshop goals were to develop recommendations regarding the needs for measurement traceabity for health status markers to (1) address IVD industry needs for compliance with international standards (e.g., EU IVD Directive) and (2) improve comparability of clinical measurement data to facilitate better decision making by medical professionals. This document is a proceedings of that workshop.
Citation: NIST Interagency/Internal Report (NISTIR) - 6742Report Number:
NIST Pub Series: NIST Interagency/Internal Report (NISTIR)
Pub Type: NIST Pubs
certified reference materials, healthcare standards, in vitro diagnostic devices, IVD directive, reference systems, traceability