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