CLSI EP32 R : 1ED 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
Hardcopy , PDF
English
17-02-2006
18-12-2025
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 |
Superseded
|
| SupersededBy |
| CLSI C37 A : 1ED 99 | PREPARATION AND VALIDATION OF COMMUTABLE FROZEN HUMAN SERUM POOLS AS SECONDARY REFERENCE MATERIALS FOR CHOLESTEROL MEASUREMENT PROCEDURES |
| CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
| CLSI EP10 A2 : 2ED 2002 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY METHODS |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
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