CLSI C51 P : 1ED 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
31-01-2012
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 Strategies to Estimate Measurement Uncertainty
5 Overview of Measurement Uncertainty
6 Bottom-up Uncertainty Estimation
7 Top-Down Approach to Estimation of Measurement Uncertainty
8 Bias Assessment
9 Uses of Uncertainty Estimates
10 Summary
References
Additional References
Appendix A - Transformation of Type B Limit Specifications
Appendix B - Uncertainty Estimates from Routine Quality
Control Results
The Quality Management System Approach
Related CLSI Reference Materials
Defines a practical approach to developing relevant and useful estimates of measurement uncertainty and for using the information to maintain and improve the quality and application of clinical laboratory measurements.
| DocumentType |
Proposed Guideline
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
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| SupersededBy |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| CLSI EP21 A : 1ED 2003 | ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS |
| CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
| CLSI EP12 A2 : 2ED 2008 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI EP7 A2 : 2ED 2005 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
| CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
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