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CLSI H1 A5 : 5ED 2003

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

TUBES AND ADDITIVES FOR VENOUS BLOOD SPECIMEN COLLECTION

Superseded date

29-12-2010

Published date

12-01-2013

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.

DevelopmentNote
Supersedes NCCLS H1 A4. (01/2004)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

CLSI H54 A : 1ED 2005 PROCEDURES FOR VALIDATION OF INR AND LOCAL CALIBRATION OF PT/INR SYSTEMS
CLSI H43 A2 : 2ED 2007 CLINICAL FLOW CYTOMETRIC ANALYSIS OF NEOPLASTIC HEMATOLYMPHOID CELLS
CLSI POCT7 A :2010(R2018) Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection
CLSI H21 A5 : 5ED 2008 COLLECTION, TRANSPORT, AND PROCESSING OF BLOOD SPECIMENS FOR TESTING PLASMA-BASED COAGULATION ASSAYS AND MOLECULAR HEMOSTASIS ASSAYS
CLSI GP34 P : 1ED 2009 VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
CLSI H20 A2 : 2ED 2007 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, 2nd Edition<br>
CLSI H58 AE : 1ED 2008 PLATELET FUNCTION TESTING BY AGGREGOMETRY
CLSI GP34 A : 1ED 2010 VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
CLSI H58 P : 1ED 2007 PLATELET FUNCTION TESTING BY AGGREGOMETRY
CLSI GP41 A6 : 6ED 2007 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
CLSI GP42 A6 : 6ED 2008 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS

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