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.

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Publication Details

Chairholder: Hubert Vesper, PhD

Date of Publication: May 28, 2010

ISBN Number: 1-56238-726-X

Order Code PDF: EP30AE

Order Code Print: print not available

Edition: First

Pages: 76

EP30 Additional Details

This document was included in the CLSI document code change and rebranding that is currently in process. The code was changed from C53-A to EP30-A. Please make sure that the document title corresponds to the publication that you intend order.