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This document covers portions of the life cycle of an automated multichannel hematology system andprovides guidance for validation, verification, calibration, quality assurance (QA), and quality control(QC) through standardized approaches to ensure good laboratory science and clinical relevance. Theintended audience includes manufacturers of such devices, end-user clinical laboratories, accreditingorganizations, and regulatory bodies.

End-user clinical laboratories will also find guidance for establishment of clinically reportable intervals(CRIs) and for QA for preexamination and examination aspects of their systems.

Product Details

Published:

01/01/2010

ISBN(s):

1562387286

File Size:

1 file , 2.2 MB