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CLSI EP32 R : 1ED 2006

Current
Current

The latest, up-to-date edition.

METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

17-02-2006

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
  2.1 Quality in Laboratory Medicine
  2.2 External Environment
3 Definitions
4 Traceability
  4.1 Overview of the Process for Establishing Traceability
  4.2 Process to Establish Traceability
  4.3 Reporting Traceability in Product Literature
References
Appendix A - Traceability and Calculating Uncertainty of
             Calibrator Levels for hCG
Appendix B - XYZ Glucose Analytical System Glucose Calibrator
             Traceability Summary
Appendix C - System X Glucose Calibrator Traceability Example
Related CLSI/NCCLS Publications

Gives guidance on establishing traceability of the chemical calibration step in clinical laboratory measurements, based on the traceability requirements for in vitro diagnostic (IVD) medical devices as given in ISO 17511 and ISO 18153 and in accordance with the requirements for traceability as stated in the IVD Directive.

DevelopmentNote
Formerly CLSI X5 R. (07/2013)
DocumentType
Report
ISBN
1-56238-598-4
Pages
56
PublisherName
Clinical Laboratory Standards Institute
Status
Current

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