Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline
|Publication Date:||1 December 2010|
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/compat
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.