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CLSI EP05-A3:2014(R2019)

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-09-2019

Superseded date

17-12-2025

Superseded by

CLSI EP05:2025

€375.00
Excluding VAT

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Superseded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
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
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

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€375.00
Excluding VAT