scope:

This document provides step-by-step recommendations for validation and verification of venous and capillary blood collection devices. Capillary blood collection devices addressed in this document include only microcollection devices (see Section 3.2). It also includes guidance for ascertaining the acceptability/compatibility for clinical performance in chemistry, immunochemistry, hematology, and coagulation. This guideline does not address validation and verification for clinical performance in immunohematology, molecular diagnostics, arterial blood gas analysis, proteomics, or genomics.

The focus and procedures of this document are for quantitative measurement only. For qualitative measurement, the study requires a different study design.

This document is written for manufacturers of venous and capillary blood collection devices; assay/instrument manufacturers; all clinical laboratory personnel; and those who are responsible for acquisition, handling, and use of the equipment described in this document.