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BSI 23/30473103 DC:2023 Edition

BSI 23/30473103 DC:2023 Edition

$24.66

BS ISO 33405. Reference materials. Guidance for characterization and assessment of homogeneity and stability

Published By Publication Date Number of Pages
BSI 2023 110
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PDF Catalog

PDF Pages PDF Title
8 Foreword
9 Introduction
11 1 Scope (mandatory)
2 Normative references
12 3 Terms and definitions (mandatory)
4 Symbols
13 5 Conventions
6 An overview of reference material production
6.1 General
6.2 Summary of project design
16 6.3 Acquisition of starting material
6.4 Feasibility studies
6.5 Reference material processing
17 6.6 Homogeneity assessment
6.7 Stability assessment
6.8 Choice of measurement procedures
6.9 Metrological traceability
6.10 Characterization and uncertainty evaluation
6.11 Commutability assessment
18 6.12 Transport issues
6.13 Value assignment
6.14 Stability monitoring
6.15 Reference materials produced in repeated batches
19 7 Assessment of homogeneity
7.1 Preamble
20 7.2 Need for an experimental homogeneity study
7.3 Properties to be studied
21 7.4 Statistically valid sampling schemes
7.4.1 Minimum number of units for a homogeneity study
22 7.4.2 Use of statistical power analysis
23 7.4.3 Sampling strategies for a homogeneity study
7.5 Choice and conduct of the measurement procedure for a homogeneity study
7.5.1 Choice of measurement procedure
24 7.5.2 Conduct of measurements for homogeneity studies
25 7.6 Homogeneity study designs
7.6.1 Objective of a homogeneity study
26 7.6.2 The basic homogeneity study design – measurement in a single run
27 7.6.3 Randomized block design
7.6.4 Balanced nested design
28 7.6.5 Alternative strategies
7.7 Evaluating a homogeneity study
7.7.1 Initial inspection for measurement trends and outliers
29 7.7.2 Inspection for processing trends
30 7.7.3 Evaluation of the between-unit term – basic design
7.7.4 Evaluation of the between-unit term – randomized block design
31 7.7.5 Evaluation of the between-unit term – balanced nested design
7.7.6 Other homogeneity designs and alternative estimation methods
7.8 Insufficient repeatability of the measurement procedure
32 7.9 Within-unit homogeneity
7.9.1 Assessing the need for within-unit homogeneity study
7.9.2 Testing for significant within-unit heterogeneity
33 7.9.3 Assessing minimum sample size
34 7.10 Check for sufficient homogeneity
35 7.11 Uncertainty evaluation from homogeneity studies
8 Assessment and monitoring of stability
8.1 Preamble
37 8.2 Assessment of stability
8.2.1 Requirement for stability assessment
8.2.2 Types of (in)stability
8.2.3 General methods for assessment of stability
38 8.2.4 Need for experimental study of stability
8.3 Classification of stability studies
8.3.1 General
39 8.3.2 Classification according to conditions of measurement
8.3.3 Classification according to stability study duration and conditions
40 8.3.4 Classification by study objective
8.3.5 Designs for different storage and treatment conditions
41 8.4 General requirements for effective stability studies
8.4.1 Overview of requirements
8.4.2 Selection of units
42 8.4.3 Suitable measurement procedure(s) for stability studies
8.4.4 Appropriate experimental design
43 8.5 Evaluation of stability study results
8.5.1 General considerations for stability study data treatment
8.5.2 The basic stability study: multiple points in time at a single storage condition
45 8.5.3 Isochronous designs
47 8.5.4 Accelerated stability studies with multiple exposure conditions
51 8.5.5 Additional sources of random variation in stability studies
8.6 Action on finding of a significant trend in a stability study
52 8.7 Uncertainty evaluation from stability studies
8.7.1 General considerations for uncertainty evaluation from stability studies
8.7.2 Sources of uncertainty in predicted change over time
53 8.7.3 Estimation of stability uncertainties in the absence of significant trends
8.7.4 Evaluation of stability uncertainties in the case of a known significant trend
54 8.8 Estimation of storage lifetime (“shelf life”) from a stability study
8.9 Instructions for use related to management of stability
8.10 Stability monitoring
8.10.1 Requirements for monitoring
55 8.10.2 Choice of initial monitoring point and monitoring interval(s)
56 8.10.3 Experimental approaches and evaluation for stability monitoring
57 9 Characterization of the material
9.1 Preamble
58 9.2 Establishing metrological traceability
9.2.1 Principle
59 9.2.2 Metrological references
9.2.3 Types of measurands
60 9.2.4 Effect of sample preparation or pre-treatment
9.2.5 Verification of traceability
61 9.3 Characterization using a single reference measurement procedure (as defined in ISO/IEC€Guide€99) in a single laboratory
9.3.1 Characterization by a reference measurement procedure without direct comparison with a CRM of the same kind
62 9.3.2 Characterization by value transfer from a reference material to a closely matched candidate reference material using a single measurement procedure performed by one laboratory
63 9.3.3 Selection of RM units for single-laboratory characterization
9.3.4 Formulation methods
64 9.4 Characterization of a non-operationally defined measurand using two or more methods of demonstrable accuracy in one or more competent laboratories
9.4.1 Concept
65 9.4.2 Study design
66 9.4.3 Evaluation
67 9.4.4 Single-laboratory multi-method studies
9.5 Characterization of an operationally defined measurand using a network of competent laboratories
9.5.1 Concept
68 9.5.2 Study setup
9.5.3 Evaluation
9.6 Purity
9.6.1 General
9.6.2 Direct determination of purity
69 9.6.3 Indirect determination of purity
70 9.7 Ordinal scales
9.8 Nominal properties including identity
9.9 Characterization of non-certified values
10 Evaluating measurement uncertainty
10.1 Basis for evaluating the uncertainty of a property value of a CRM
71 10.2 Basic model for a batch characterization
10.3 Uncertainty sources
72 10.4 Coverage intervals and factors
73 Annex€A (informative) Design and evaluation of studies for the characterization of a method-independent measurand using two or more methods of demonstrable accuracy in one or more competent laboratories
84 Annex€B (informative) Statistical approaches
94 Annex€C (informative) Examples
104 Annex€D (informative) Measurement uncertainty evaluation
106 Bibliography

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