• PD ISO GUIDE 35:2017

    Current The latest, up-to-date edition.

    Reference materials. Guidance for characterization and assessment of homogeneity and stability

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-10-2017

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols
    5 Conventions
    6 An overview of reference material production
    7 Assessment of homogeneity
    8 Assessment and monitoring of stability
    9 Characterization of the material
    10 Evaluating measurement uncertainty
    Annex A (informative) - Design and evaluation of studies for
            the characterization of a method-independent
            measurand using twr more methods of demonstrable
            accuracy in one or more competent laboratories
    Annex B (informative) - Statistical approaches
    Annex C (informative) - Examples
    Annex D (informative) - Measurement uncertainty evaluation
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives concepts and provides approaches to the following aspects of the production of reference materials: - the assessment of homogeneity; - the assessment of stability and the management of the risks associated with possible stability issues related to the properties of interest; - the characterization and value assignment of properties of a reference material; - the evaluation of uncertainty for certified values; - the establishment of the metrological traceability of certified property values.

    Scope - (Show below) - (Hide below)

    This document explains concepts and provides approaches to the following aspects of the production of reference materials:

    • the assessment of homogeneity;

    • the assessment of stability and the management of the risks associated with possible stability issues related to the properties of interest;

    • the characterization and value assignment of properties of a reference material;

    • the evaluation of uncertainty for certified values;

    • the establishment of the metrological traceability of certified property values.

    The guidance given supports the implementation of ISO17034 . Other approaches may also be used as long as the requirements of ISO17034 are fulfilled.

    Brief guidance on the need for commutability assessment (6.11) is given in this document, but no technical details are provided. A brief introduction for the characterization of qualitative properties (9.6 to 9.10) is provided together with brief guidance on sampling such materials for homogeneity tests (Clause 7). However, statistical methods for the assessment of the homogeneity and stability of reference materials for qualitative properties are not covered. This document is also not applicable to multivariate quantities, such as spectral data.

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

    Committee RMI/1
    Document Type Standard
    Publisher British Standards Institution
    Status Current

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 17034:2016 General requirements for the competence of reference material producers
    ISO 11843-1:1997 Capability of detection Part 1: Terms and definitions
    ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO/TR 16476:2016 Reference materials — Establishing and expressing metrological traceability of quantity values assigned to reference materials
    ISO/TR 79:2015 Reference materials - Examples of reference materials for qualitative properties
    ISO 16269-4:2010 Statistical interpretation of data Part 4: Detection and treatment of outliers
    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 Guide 33:2015 Reference materials Good practice in using reference materials
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 3534-2:2006 Statistics Vocabulary and symbols Part 2: Applied statistics
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    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 3534-3:2013 Statistics — Vocabulary and symbols — Part 3: Design of experiments
    ISO 6865:2000 Animal feeding stuffs — Determination of crude fibre content — Method with intermediate filtration
    ISO 6142-1:2015 Gas analysis Preparation of calibration gas mixtures Part 1: Gravimetric method for Class I mixtures
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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