CLSI H1 A5 : 5ED 2003

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Materials
   4.1 Tube
   4.2 Construction
   4.3 Closure Material
   4.4 Specifications
   4.5 Purified Ion Exchange Water
5 System Specifications
   5.1 Compatibility
   5.2 Tube Size
   5.3 Compatibility with Centrifuge Carriers
6 Closure Design
7 Construction
   7.1 Strength
   7.2 Exterior Texture
8 Limits of Interference
   8.1 Warning on Package Label
   8.2 Cleanliness of Interior
9 Additional Requirements
   9.1 Draw and Fill Accuracy
   9.2 Additive Tolerance
   9.3 Solution Strength
   9.4 Collection Needles
10 Marking and Labeling
   10.1 Instructions
   10.2 Identification
   10.3 Sterile Tubes
11 Additives
Bibliography
Appendix A. Evaluation of Venous Blood Collection Tubes
Appendix B. Evaluation of the Closure Assembly
Appendix C. Centrifuge Test
Appendix D. Additives to Blood Collection Devices: EDTA
Appendix E. Additives to Blood Collection Devices: Heparin
Appendix F. Additives to Blood Collection Devices: Sodium
            Citrate
Summary of Comments and Working Group Responses
Summary of Delegate Comments and Working Group Responses
The Quality System Approach
Related NCCLS Publications

Discusses single-use, venous blood collection tubes. Also provides a description, mode of action, specifications, and assay methods for additives to blood collection devices, including ethylenediaminetetraacetic acid (EDTA), heparin, and sodium citrate.