scope:

This document addresses the methodology and devices for the measurement of the erythrocyte sedimentation rate (ESR) phenomenon. It also provides guidance for validation, verification, quality assurance (QA), and quality control (QC) through standardized approaches to ensure good laboratory science and clinical relevance. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies.

End-user clinical laboratories will also find guidance for establishment of working methods for ESR test validation and for QA of their ESR testing method(s).