PD ISO GUIDE 35:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Reference materials. Guidance for characterization and assessment of homogeneity and stability
Hardcopy , PDF
09-05-2024
English
31-10-2017
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.
Committee |
RMI/1
|
DocumentType |
Standard
|
Pages |
118
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy |
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.
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) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.