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BS ISO 33405:2024

BS ISO 33405:2024

$215.11

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

Published By Publication Date Number of Pages
BSI 2024 110
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PDF Catalog

PDF Pages PDF Title
2 undefined
8 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
12 4 Symbols
13 5 Conventions
6 Overview of reference material production
6.1 General
6.2 Summary of project design
15 6.3 Acquisition of starting material
16 6.4 Feasibility studies
6.5 Reference material processing
6.6 Homogeneity assessment
6.7 Stability assessment
17 6.8 Choice of measurement procedures
6.9 Metrological traceability
6.10 Characterization and uncertainty evaluation
6.11 Commutability assessment
6.12 Transport issues
18 6.13 Value assignment
6.14 Stability monitoring
6.15 Reference materials produced in repeated batches
7 Assessment of homogeneity
7.1 Preamble
19 7.2 Need for an experimental homogeneity study
20 7.3 Properties to be studied
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
7.4.3 Sampling strategies for a homogeneity study
23 7.5 Choice and conduct of the measurement procedure for a homogeneity study
7.5.1 Choice of measurement procedure
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
7.6.5 Alternative strategies
28 7.7 Evaluating a homogeneity study
7.7.1 Initial inspection for measurement trends and outliers
29 7.7.2 Inspection for processing trends
7.7.3 Evaluation of the between-unit term – basic design
30 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
32 7.8 Insufficient repeatability of the measurement procedure
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
34 7.9.3 Assessing minimum sample size
35 7.10 Check for sufficient homogeneity
36 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
38 8.2.3 General methods for assessment of stability
8.2.4 Need for experimental study of stability
39 8.3 Classification of stability studies
8.3.1 General
8.3.2 Classification according to conditions of measurement
40 8.3.3 Classification according to stability study duration and conditions
8.3.4 Classification by study objective
41 8.3.5 Designs for different storage and treatment conditions
42 8.4 General requirements for effective stability studies
8.4.1 Overview of requirements
8.4.2 Selection of RM units
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
44 8.5.2 The basic stability study: multiple points in time at a single storage condition
46 8.5.3 Isochronous designs
48 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 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
9.2.2 Metrological references
59 9.2.3 Types of measurands
9.2.4 Effect of sample preparation or pre-treatment
60 9.2.5 Verification of traceability
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
61 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
62 9.3.3 Selection of RM units for single-laboratory characterization
9.3.4 Formulation methods
63 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
64 9.4.2 Study design
65 9.4.3 Evaluation
66 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
67 9.5.2 Study setup
9.5.3 Evaluation
9.6 Purity
9.6.1 General
9.6.2 Direct determination of purity
68 9.6.3 Indirect determination of purity
69 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
70 10.2 Basic model for a batch characterization
71 10.3 Uncertainty sources
10.4 Coverage intervals and factors
72 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
83 Annex B (informative) Statistical approaches
94 Annex C (informative) Examples
104 Annex D (informative) Measurement uncertainty evaluation
105 Bibliography

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BS ISO 33405:2024
$215.11