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  • UNI CEN/TR 10345 : 2008

    Current The latest, up-to-date edition.

    Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods

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    Language(s): 

    Published date:  03-12-2008

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Principle
    4 Preliminary rules
      4.1 First rule ('to be clear')
      4.2 Second rule ('to be modest')
      4.3 Minimal characteristics of data population
    5 Procedure
      5.1 Bases
      5.2 Raw data examination
      5.3 Intra laboratory repeatability variance
          (Cochran's test)
      5.4 Intra laboratory reproducibility variance
          (Grubbs' test)
      5.5 Inter laboratory reproducibility variance
          (Grubbs' test)
      5.6 Retained data examination
      5.7 Calculation of the variances associated to
          the tested method
      5.8 Treatment for unexpected calculated variances
      5.9 Estimation of a function linking variance and
          level
    6 Report
    7 General remarks
    Annex A - Steps for the validation of a Draft Standard
    Annex B - Synoptic of the operations described in Annex A
    Annex C - Examples
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides guidelines to carry out the statistical evaluation of data from an inter laboratory test for method validation.

    General Product Information - (Show below) - (Hide below)

    Committee CT 700
    Document Type Technical Report
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    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 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
    NFX 06 050 : 1995 APPLICATION OF STATISTICS - STUDY OF THE NORMALITY OF A DISTRIBUTION
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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