CLSI C53 P : 1ED 2008

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
   4.1 A Note on Terminology
   4.2 Definitions
   4.3 Abbreviations/Acronyms
5 Qualification Requirements
   5.1 Definition of the Measurand
   5.2 Intended Use
   5.3 Material Specifications
6 Characterization of Homogeneity, Stability, and Property Value
   6.1 Characterization of Homogeneity
   6.2 Characterization of Stability
   6.3 Establishing Traceability
7 Characterization of Commutability of Reference Materials
   7.1 General Considerations Regarding Samples and Measurement
        Procedures Used for Commutability Validation
   7.2 Logistical Considerations of a Commutability Validation
   7.3 Procedures for Commutability Validation and Assessing
        Numeric Relationships
   7.4 Selection of a Procedure to Validate Commutability
   7.5 Criteria for Acceptance of the Equivalence of the
        Mathematical Relationship for Native Clinical Samples
        and Candidate Reference Materials
   7.6 Reporting Commutability Information
8 Considerations for Reference Materials Intended for
   Immediate Use and/or Limited Available Quantities
References
Appendix A - Examples of Value Transfer Procedures
Appendix B - Hypothetical Data Set Used for Examples of
             Procedures for Assessment of Commutability
Appendix C - Description of Mathematical Model Used for
             Evaluating Commutability of Reference Materials
             Using Deming Regression
Appendix D - Procedure for Establishing Commutability of a
             Reference Material With Native Clinical Specimens
             for a Pair of Measurement Methods With Deming
             Regression
The Quality Management System Approach
Related CLSI Reference Materials