Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 1st Edition
This document provides information to help material manufacturers in the production and characterization of commutable reference materials as well as assist assay manufacturers, proficiency testing providers, and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of April 2016. The document’s next scheduled review is generally five years after the reaffirmation date.
This document is available in electronic format only.
Chairholder: Hubert Vesper, PhD
Date of Publication: May 28, 2010
Order Code PDF: EP30AE
ISBN Number: 1-56238-726-X
Order Code Print: print not available