CLSI EP05-A3:2014(R2019)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
Hardcopy , PDF
English
01-09-2019
17-12-2025
This document provides guidance for studies intended to establish the within-site precision performance characteristics of quantitative measurement procedures used in clinical laboratories, and also for studies addressing site-to-site variability.
| DocumentType |
Standard
|
| Pages |
120
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| CLSI EP12:2023 | Evaluation of Qualitative, Binary Output Examination Performance |
| CLSI EP35 : 2019 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition |
| CLSI EP34:2018(R2023) | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking |
| CLSI EP21:2025 | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
| CLSI EP35:2025 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
| CLSI C49:2018(R2023) | Analysis of Body Fluids in Clinical Chemistry |
| CLSI EP06 ED2:2020 | Evaluation of Linearity of Quantitative Measurement Procedures, 2nd Edition |
| CLSI EP47:2024 | Evaluation of Reagent Carryover Effects on Test Results |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| ISO 5725-3:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method |
| ISO 15198:2004 | Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
| ISO 18153:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials |
| ISO 17511:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials |
| ISO 3534-2:2006 | Statistics — Vocabulary and symbols — Part 2: Applied statistics |
| CLSI EP15 A3 : 3ED 2014 | USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS |
| ISO 5725-2:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| ISO 5725-5:1998 | Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method |
| CLSI C56 A : 1ED 2012 | HEMOLYSIS, ICTERUS, AND LIPEMIA/TURBIDITY INDICES AS INDICATORS OF INTERFERENCE IN CLINICAL LABORATORY ANALYSIS |
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