ISO/TR 11843-8:2021

TECHNICAL ISO/TR
REPORT 11843-8
First edition
2021-11
Capability of detection —
Part 8:
Guidance for the implementation of
the ISO 11843 series
Capacité de détection —
Partie 8: Recommandations pour la mise en œuvre de la série ISO
Reference number
© ISO 2021
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ii
Contents Page
Foreword .iv
0       Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 Terms and definitions . 1
3.2 Symbols . 1
4 Historical survey of terms . 3
5 Fundamental concepts of detection limit (minimum detectable value in ISO 11843) .4
5.1 General . 4
5.2 General definition of detection limit . 4
5.3 Detection limit with probability α . 5
5.4 Detection limit with probabilities α and β . 6
6 Pragmatic view of α and β . 9
6.1 Statistical definitions of α and β . 9
6.2 Actual examples of α and β values . 9
7 In-depth explanations and examples of the Parts in the ISO 11843 series .9
7.1 General . 9
7.2 ISO 11843-3 and ISO 11843-4 . 10
7.2.1 General . 10
7.2.2 Number of repeated measurements, J and K . 10
7.2.3 Determination of the minimum detectable value . 11
7.2.4 Confirmation of the minimum detectable value for an obtained
experimental value with the number of repeated measurements, N . 11
7.2.5 Number of repeated measurements, J and K, in ISO 11843-5 and ISO 11843-7 .13
7.3 ISO 11843-6 . 13
7.3.1 Overview of ISO 11843-6 . 13
7.3.2 Features of pulse count measurement . 13
7.4 Example from ISO 11843-7 . 19
Annex A (informative) Standard normal random variable .23
Annex B (informative) Difference between the power of test and
the minimum detectable value .25
Annex C (informative) Calculation example from ISO 11843-4 .27
Annex D (informative) Calculation example from ISO 11843-6:2019, Annex E (Measurement
of hazardous substances by X-ray diffractometer) .28
Annex E (informative) Comparison between the Poisson exact arithmetic and
the approximations .31
Annex F (informative) Association of IUPAC recommended detection limit
with the ISO 11843 series .36
Bibliography .38
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 69, Applications of statistical methods,
Subcommittee SC 6, Measurement methods and results.
A list of all parts in the ISO 11843 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
0 Introduction
0.1  General
The purpose of this document is to facilitate the dissemination of the principles and methods of the
ISO 11843 series on a global scale by providing a brief explanation of the background of its development,
the significance of defining detection limits, the historical variation of the term detection limit, the
modern concept of detection limit, and basic ideas of statistics and of each part of this series, intelligible
to analytical chemists, biologists, operators, technicians, and others in various fields.
The series ISO 11843 provides statistical theories and some practical applications in a mathematically
strict way. This guidance is put forth with the goal of guiding laymen in statistics in practicing the
statistics of detection limits, not offering the in-depth knowledge of the relevant mathematics, but
making them aware of some of the challenges of using statistical theory and the reasons for success and
failure in using the formulae included in the series.
0.2  Background
[1]
The concept of detection limit was first described in 1949 ; after that, a number of scientists submitted
[2][3]
papers on the definition of detection limit . Scientists in different countries have used detection
limits with different definitions.
In order to avoid such global confusion, the International Union of Pure and Applied Chemistry
(IUPAC) began considering the introduction of a modern detection limit using a new definition based
on statistics. Representatives of the IUPAC and the International Organization for Standardization
(ISO) met between 1993 and 1997 to begin efforts to develop a harmonized international chemical-
metrological position on detection and quantification capabilities. The IUPAC nomenclature document
was published in 1995 to help establish a uniform and meaningful approach to terminology, notation,
and formulation for performance characteristics of the chemical measurement process, and in 1997
ISO published its standard (ISO 11843) for the international metrological community. IUPAC has
incorporated the 1995 recommendations into its basic nomenclature volume, the Compendium on
Analytical Nomenclature (IUPAC, 1998).
0.3  Parts of ISO 11843
The ISO 11843 series consists of the following published parts:
— ISO 11843-1, Capability of detection — Part 1: Terms and definitions;
— ISO 11843-2, Capability of detection — Part 2: Methodology in the linear calibration case;
— ISO 11843-3, Capability of detection — Part 3: Methodology for determination of the critical value
for the response variable when no calibration data are used;
— ISO 11843-4, Capability of detection — Part 4: Methodology for comparing the minimum detectable
value with a given value;
— ISO 11843-5, Capability of detection — Part 5: Methodology in the linear and non-linear calibration
cases;
— ISO 11843-6, Capability of detection — Part 6: Methodology for the determination of the critical value
and the minimum detectable value in Poisson distributed measurements by normal approximations;
— ISO 11843-7, Capability of detection — Part 7: Methodology based on stochastic properties of
instrumental noise.
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0.4  Social purposes
0.4.1 Significance of defining the minimum detectable value
The determination of the minimum detectable value is sometimes important in practical work. The
value provides a criterion for deciding when “the signal is certainly not detected”, or when “the signal
is significantly different from the background noise level". For example, it is valuable when measuring
the presence of hazardous substances, the degree of calming of radioactive contamination, and surface
contamination of semiconductor materials, as follows.
— RoHS (Restrictions on Hazardous Substances) sets limits on the use of six hazardous materials
(hexavalent chromium, lead, mercury, cadmium and the flame retardant agents perbromobiphenyl,
PBB, and perbromodiphenyl ether, PBDE) in the manufacturing of electronic components and
related goods sold in the EU.
— Environmental pollution by radioactive materials due to accidents at nuclear power plants is a major
problem. While it takes a considerable amount of time for the contaminated environment to return
to its original state, it is important to monitor the state of contamination during that time.
— The condition of an analyser to be quantified when assessing the limiting performance of an
instrument.
0.4.2  Trouble prevention with stakeholders
To avoid problems with stakeholders, concerning the
...