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PD ISO GUIDE 35:2017

Current

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

10-31-2017

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

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.

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.

Committee
RMI/1
DocumentType
Standard
Pages
118
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO Guide 35:2017 Identical

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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