SIST-TS CEN/TS 16800:2016
(Main)Guideline for the validation of physico-chemical analytical methods
Guideline for the validation of physico-chemical analytical methods
This Technical Specification describes an approach for the validation of physico-chemical analytical methods for environmental water matrices.
The guidance in this document addresses two different validation approaches, in increasing order of complexity. These are:
a) method development and validation at the level of single laboratories (intra-laboratory validation);
b) method validation at the level of several laboratories (between-laboratory or inter-laboratory validation), with a focus on methods that are sufficiently mature and robust to be applied not only by a few expert laboratories but by laboratories operating at the routine level.
The concept of these two approaches is strictly hierarchical, i. e. a method shall fulfil all criteria of the first level before it can enter the validation protocol of the second level.
This Technical Specification is applicable to the validation of a broad range of quantitative physico-chemical test methods for the analysis of water (including surface water, groundwater, waste water, and sediment). Test methods for other environmental matrices, like soil, sludge, waste, and biota can be validated in the same way. It is intended either for test methods aiming at substances that have recently become of interest or for test methods applying recently developed technologies.
The minimal requirements that are indispensable for the characterization of the fitness for purpose of an analytical method are: selectivity, precision, bias, measurement uncertainty. The aim of validation is to prove that these requirements are met.
Anleitung zur Validierung physikalisch-chemischer Analysenverfahren
Diese Technische Spezifikation beschreibt einen Ansatz für die Validierung von physikalisch-chemischen Analysenverfahren für Wasserproben-Matrices aus der Umwelt.
Die Anleitung im vorliegenden Dokument behandelt zwei verschiedene Validierungsansätze mit zunehmender Komplexität. Diese sind:
- Verfahrensentwicklung und -validierung auf Ebene eines einzelnen Laboratoriums (laborinterne Validierung);
- Verfahrensvalidierung auf Ebene mehrerer Laboratorien (laborübergreifende Validierung) mit Konzen¬tration auf Verfahren, die hinreichend ausgereift und robust sind, damit sie nicht nur von einigen Experten-laboratorien sondern auch von auf Routineniveau arbeitenden Laboratorien angewendet werden können.
Das Konzept dieser beiden Ansätze ist strikt hierarchisch, d. h. ein Verfahren muss alle Kriterien der ersten Ebene erfüllen, bevor es in das Validierungsprotokoll der zweiten Ebene aufgenommen wird.
Diese Technische Spezifikation gilt für die Validierung einer Vielfalt von quantitativen physikalisch-chemischen Untersuchungsverfahren für die Analyse von Wasser (einschließlich Oberflächenwasser, Grundwasser, Abwasser und Sediment). Untersuchungsverfahren für andere Umweltprobenmatrices, wie Boden, Schlamm, Abfall und Biota, können in gleicher Weise validiert werden. Sie ist entweder für Untersuchungsverfahren vorgesehen, die auf neue interessierende Stoffe ausgerichtet sind, oder für Untersuchungsverfahren, die neuentwickelte Technologien anwenden.
Die für die Charakterisierung der Gebrauchstauglichkeit eines Analysenverfahrens unabdingbaren Mindest-anforderungen sind Empfindlichkeit, systematische Abweichung (Bias) und Messunsicherheit. Das Ziel der Validierung besteht im Nachweis der Einhaltung dieser Anforderungen.
Lignes directrices pour la validation des méthodes d'analyse physico-chimiques
La présente Spécification technique décrit une approche de validation des méthodes d'analyse physico-chimiques destinées aux matrices d'eau issues de l'environnement.
Les préconisations du présent document abordent deux approches de validation différentes, par ordre croissant de complexité. Ces approches sont les suivantes :
a) mise au point et validation des méthodes à l'échelle de laboratoires individuels (validation intralaboratoire) ;
b) validation des méthodes à l'échelle de plusieurs laboratoires (validation interlaboratoires), avec ciblage des méthodes suffisamment abouties et robustes pour être appliquées non seulement par quelques laboratoires experts, mais aussi par des laboratoires d'analyses de routine.
Le concept de ces deux approches est strictement hiérarchisé, c'est-à-dire qu'une méthode doit remplir tous les critères du premier niveau avant de pouvoir accéder au protocole de validation de second niveau.
La présente Spécification technique est applicable à la validation d'une large gamme de méthodes d'essai physico chimiques quantitatives destinées à l'analyse des eaux (y compris des eaux de surface, des eaux souterraines, des eaux usées et des sédiments). Les méthodes d'essai destinées à d'autres matrices environnementales, telles que le sol, les boues, les déchets et le biote, peuvent être validées de la même manière. La présente Spécification technique s'adresse soit à des méthodes d'essai visant des substances qui suscitent un nouvel intérêt, soit à des méthodes d'essai qui appliquent des technologies récemment mises au point.
Les exigences minimales indispensables à la caractérisation de l'aptitude à l'emploi d'une méthode analytique sont la sélectivité, la fidélité, le biais et l'incertitude de mesure. La validation a pour objectif de prouver que ces exigences sont satisfaites.
Smernica za validacijo fizikalno-kemijskih analiznih metod
V tej tehnični specifikaciji je opisan pristop za validacijo fizikalno-kemijskih analiznih metod za okoljske vodne matrice.
Navodila v tem dokumentu naslavljajo dva različna pristopa k validaciji, pri čemer stopnja zapletenosti narašča. Ta pristopa sta:
a) razvijanje in validacija metode na ravni posameznih laboratorijev (validacija znotraj laboratorija);
b) validacija metode na ravni več laboratorijev (validacija med laboratoriji ali medlaboratorijska validacija) s poudarkom na metodah, ki so dovolj zrele in robustne, da jih lahko uporabljajo tudi laboratoriji, ki delujejo na rutinski ravni, in ne le nekaj specializiranih laboratorijev.
Koncept teh dveh pristopov je strogo hierarhičen, tj. metoda mora izpolniti vse kriterije na prvi ravni, preden lahko vstopi v protokol validacije na drugi ravni.
Ta tehnična specifikacija velja za validacijo široke palete kvantitavnih fizikalno-kemijskih preskusnih metod za analizo vode (vključno s površinsko vodo, podtalnico, odpadnimi vodami in usedlinami). Preskusne metode za druge okoljske matrice, na primer zemljino, blato, odpad in žive organizme, je mogoče validirati na enak način. Namenjen je za preskusne metode za snovi, ki so nedavno postale zanimive, ali za preskusne metode, pri katerih se uporabljajo nedavno razvite tehnologije.
Minimalne zahteve, ki so nujne za karakterizacijo primernosti za namen analitične metode, so: selektivnost, natančnost, pristranskost, negotovost merjenja. Cilj validacije je potrditev izpolnitve teh zahtev.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN/TS 16800:2016
01-februar-2016
Smernica za validacijo fizikalno-kemijskih analiznih metod
Guideline for the validation of physico-chemical analytical methods
Anleitung zur Validierung physikalisch-chemischer Analysenverfahren
Lignes directrices pour la validation des méthodes d'analyse physico-chimiques
Ta slovenski standard je istoveten z: CEN/TS 16800:2015
ICS:
13.060.50 3UHLVNDYDYRGHQDNHPLþQH Examination of water for
VQRYL chemical substances
SIST-TS CEN/TS 16800:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN/TS 16800:2016
CEN/TS 16800
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
December 2015
TECHNISCHE SPEZIFIKATION
ICS 13.060.50
English Version
Guideline for the validation of physico-chemical analytical
methods
Lignes directrices pour la validation des méthodes Anleitung zur Validierung physikalisch-chemischer
d'analyse physico-chimiques Analysenverfahren
This Technical Specification (CEN/TS) was approved by CEN on 14 March 2015 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16800:2015 E
worldwide for CEN national Members.
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Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Concept . 13
4.1 The concept of two validation levels . 13
4.2 First level - Validation 1 (V1) . 13
4.3 Second level - Validation 2 (V2) . 13
4.4 Method validation using a modular approach . 13
4.4.1 Validation modules . 13
4.4.2 Module A: Test method definition, documentation and general requirements . 13
4.4.3 Module B: Applicability domain and pre-validation . 14
4.4.4 Module C: Intra-laboratory performance . 14
4.4.5 Module D: Inter-laboratory performance . 14
4.5 Method classification . 15
5 Documentation of the validation process . 16
6 Validation 1 (V1): Intra-Laboratory Validation . 17
6.1 General . 17
6.2 Module A: Test method definition, documentation and general requirements . 17
6.3 Module B: Applicability domain and pre-validation . 18
6.4 Module C: Intra-laboratory performance . 18
6.4.1 General . 18
6.4.2 Bias . 18
6.4.3 Precision . 19
6.4.4 Calibration data and function . 20
6.4.5 Limits and application range . 21
6.4.6 Selectivity . 22
6.4.7 Robustness. 23
6.4.8 Measurement uncertainty . 23
7 Validation 2 (V2): Inter-Laboratory Validation . 23
7.1 General . 23
7.2 Method definition and description . 24
7.3 Module C: Intra-laboratory performance . 24
7.4 Module D: Inter-laboratory performance . 24
7.4.1 General . 24
7.4.2 General set-up of the inter-laboratory study . 25
7.4.3 The inter-laboratory study . 26
7.4.4 Statistical analysis and calculation of the results . 27
7.4.5 Evaluation of the fitness for purpose . 28
7.5 Documentation, publication and standardization . 31
Annex A (normative) Module A: Test method definition, documentation and general
requirements . 32
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Annex B (normative) Module B: Applicability domain and pre-validation . 34
Annex C (normative) Module C: Intra-laboratory performance . 35
Annex D (normative) Module D: Requirements for an inter-laboratory validation study . 37
Annex E (informative) Structure and content of the documentation for a validation study
(V2) . 39
Annex F (informative) Robustness testing by systematic variation of influencing factors . 44
Bibliography . 46
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European foreword
This document (CEN/TS 16800:2015) has been prepared by Technical Committee CEN/TC 230 “Water
analysis”, the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
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Introduction
Environmental monitoring of chemical substances is increasingly carried out within a European
framework, and there is concern about the comparability of data at the European level. In particular
methods used for the monitoring of substances with recent interest have often not been properly
validated either in-house (i.e. within a single laboratory) or at the international level.
These issues may be addressed by adopting a harmonized approach towards method development and
validation. The main objective of this document is to provide a common European approach to the
validation of chemical methods for the respective monitoring of chemical substances in a broad range of
matrices. Although the development of this approach was triggered by the needs for monitoring of
emerging pollutants, it is of general nature and can be applied to the measurement of a wide range of
substances in a variety of matrices.
This guidance takes into account the different requirements for the level of method maturity and
validation at different stages of the investigation or regulation of chemical substances.
In the case of a specific monitoring task, this protocol will guide the user through the following steps:
— classification of existing methods with respect to their status of validation, and the selection of the
appropriate validation approach;
— development of a method so as to extend its application; for example, if a method for determining a
required target compound in a particular matrix is available, but is not suitable for the same
compound in a different matrix of interest;
— the validation procedures to be carried out in order to effectively demonstrate the validation status
of a selected method according to the two approaches adopted.
Many (national and international) standards currently contain in their scope a statement like “this
method is applicable from a concentration level of xx µg/l or yy mg/kg dry matter”, without any
statement how this concentration level was established. When the limit of quantification (LOQ) is
evaluated using the procedure of this Technical Specification, there is a possibility that it does not meet
the lower limit of the claimed range.
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1 Scope
This Technical Specification describes an approach for the validation of physico-chemical analytical
methods for environmental matrices.
The guidance in this document addresses two different validation approaches, in increasing order of
complexity. These are:
a) method development and validation at the level of single laboratories (intra-laboratory validation);
b) method validation at the level of several laboratories (between-laboratory or inter-laboratory
validation), with a focus on methods that are sufficiently mature and robust to be applied not only
by a few expert laboratories but by laboratories operating at the routine level.
The concept of these two approaches is strictly hierarchical, i.e. a method shall fulfil all criteria of the
first level before it can enter the validation protocol of the second level.
This Technical Specification is applicable to the validation of a broad range of quantitative physico-
chemical analytical methods for the analysis of water (including surface water, groundwater, waste
water, and sediment). Analytical methods for other environmental matrices, like soil, sludge, waste, and
biota can be validated in the same way. It is intended either for analytical methods aiming at substances
that have recently become of interest or for test methods applying recently developed technologies.
The minimal requirements that are indispensable for the characterization of the fitness for purpose of
an analytical method are: selectivity, precision, bias and measurement uncertainty. The aim of
validation is to prove that these requirements are met.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 78-2, Chemistry — Layouts for standards — Part 2: Methods of chemical analysis
ISO 5725, Chemistry — Layouts for standards — Part 2: Methods of chemical analysis
ISO 11352:2012, Water quality — Estimation of measurement uncertainty based on validation and
quality control data
ISO 21748:2010, Guidance for the use of repeatability, reproducibility and trueness estimates in
measurement uncertainty estimation
ISO/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99:2007 (VIM) and
the following apply.
3.1
accepted reference value
value that serves as an agreed-upon reference for comparison, and which is derived as:
a) a theoretical or established value, based on scientific principles;
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b) an assigned or certified value, based on experimental work of some national or international
organization;
c) a consensus or certified value, based on collaborative experimental work under the auspices of a
scientific or engineering group;
d) when a), b) and c) are not available, the expectation of the (measurable) quantity, i.e. the mean of a
specified population of measurements
[SOURCE: ISO 3534-2:2006, definition 3.2.7]
3.2
accuracy
closeness of agreement between a test result and the accepted reference value
[SOURCE: ISO 3534-2:2006, definition 3.3.1]
Note 1 to entry: The term accuracy, when applied to a set of test results, involves a combination of random
components (usually expressed by a precision measure) and a common systematic error or bias component
(usually expressed by a measure for trueness).
Note 2 to entry: The technical term "accuracy" should not be confused with the term ‘trueness’ (see definition of
"trueness").
3.3
analyte
substance to be analysed (chemical species or physical parameter)
Note 1 to entry: The quantity of an analyte is the measurand (3.15).
3.4
bias
difference between the expectation of a test result or measurement result and a true value
Note 1 to entry: Bias is the total systematic error as contrasted to random error. There may be one or more
systematic error components contributing to the bias. A larger systematic difference from the accepted reference
value is reflected by a larger bias value.
Note 2 to entry: The bias of a measuring instrument is normally estimated by averaging the error of indication
over an appropriate number of repeated measurements. The error of indication is the: "indication of a measuring
instrument minus a true value of the corresponding input quantity".
Note 3 to entry: In practice, accepted reference value is substituted for the true value.
[SOURCE: ISO 3534-2:2006, definition 3.3.2]
3.5
blank
sample or test scheme without the analyte known to produce the measured signal
Note 1 to entry: Use of various types of blanks enable assessment of which proportion of the measured signal is
attributable to the measurand and which proportion to other causes. Various types of blank are available (see
definition of reagent blank and blank sample).
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3.6
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity
values with measurement uncertainties provided by measurement standards and corresponding
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relation for obtaining a measurement result from an indication
Note 1 to entry: A calibration may be expressed by a statement, calibration function, calibration diagram,
calibration curve, or calibration table. In some cases, it may consist of an additive or multiplicative correction of
the indication with associated measurement uncertainty.
Note 2 to entry: Calibration should not be confused with adjustment of a measuring system, often mistakenly
called “self-calibration”, nor with verification of calibration.
[SOURCE: ISO/IEC Guide 99:2007, definition 2.39]
3.7
certified reference material
CRM
reference material, accompanied by documentation issued by an authoritative body and providing one
or more specified property values with associated uncertainties and traceabilities, using valid
procedures
[SOURCE: ISO/IEC Guide 99:2007, definition 5.14]
3.8
fitness for purpose
degree to which data produced by a measurement process enables a user to make technically and
administratively correct decisions for a stated purpose
3.9
intermediate precision
precision under intermediate precision conditions
[SOURCE: ISO 3534-2:2006, definition 3.3.15]
3.10
intermediate precision conditions
conditions where test results or measurement results are obtained with the same method, on identical
test/measurement items in the same test or measurement facility, under some different operating
conditions
Note 1 to entry: There are four elements to the operating condition: time, calibration, operator and equipment.
[SOURCE: ISO 3534-2:2006, definition 3.3.16 and ISO 11352:2012, definition 3.10]
3.11
limit of detection
measured quantity value, obtained by a given measurement procedure, for which the probability of
falsely claiming the absence of a component in a material is β, given a probability α of falsely claiming
its presence
Note 1 to entry: IUPAC recommends default values for α and β equal to 0,05.
Note 2 to entry: The abbreviation LOD is sometimes used.
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Note 3 to entry: The term “sensitivity” is discouraged for ‘detection limit’.
[SOURCE: ISO/IEC Guide 99:2007, definition 4.18]
Note 4 to entry: The LOD is the lowest concentration of measurand in a sample that can be detected, but not
necessarily quantitated under the stated conditions of the test.
3.12
limit of quantitation
lowest concentration of a measurand that can be determined with acceptable precision under the stated
conditions of the test
3.13
reporting limit
specific concentration at or above the limit of quantification that is reported to the client with a certain
degree of confidence
Note 1 to entry: The reporting limit is often defined on a project-specific basis. If the reporting limit is set below
the limit of quantification by the client, method modification is required.
[SOURCE: ISO/TS 13530:2009, 4.4.7]
3.14
linearity
ability of the method to obtain test results proportional to the concentration of measurand
Note 1 to entry: The linear range is by inference the range of measurand concentrations over which the method
gives test results proportional to the concentration of the measurand.
[SOURCE: EURACHEM Guide]
3.15
measurand
quantity intended to be measured
Note 1 to entry: The specification of a measurand requires knowledge of the kind of quantity, description of the
state of the phenomenon, body, or substance carrying the quantity, including any relevant component, and the
chemical entities involved.
Note 2 to entry: In chemistry, “analyte”, or the name of a substance or compound, are terms sometimes used for
“measurand”. This usage is erroneous because these terms do not refer to quantities.
[SOURCE: ISO/IEC Guide 99:2007, definition 2.3]
3.16
measurement
process of experimentally obtaining one or more quantity values that can reasonably be attributed to a
quantity
[SOURCE: ISO/IEC Guide 99:2007, definition 2.1]
3.17
measurement uncertainty
non-negative parameter characterizing the dispersion of the quantity values being attributed to a
measurand, based on the information used
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[SOURCE: ISO/IEC Guide 99:2007, definition 2.26].
3.18
outlier
member of a set of values which is inconsistent with the other members of that set
Note 1 to entry: ISO 5725-2 specifies the statistical tests and the significance level to be used to identify outliers
in trueness and precision experiments.
[SOURCE: ISO 5725-1:1994, definition 3.21]
3.19
precision
closeness of agreement between independent test results obtained under stipulated conditions
Note 1 to entry: Precision depends only on the distribution of random errors and does not relate to the true
value or the specified value.
Note 2 to entry: The measure of precision is usually expressed in terms of imprecision and computed as a
standard deviation of the test results. Less precision is reflected by a larger standard deviation.
[SOURCE: ISO 3534-2:2006, definition 3.3.4]
Note 3 to entry: „Independent test results“ means results obtained in a manner not influenced by any previous
result on the same or similar test object. Quantitative measures of precision depend critically on the stipulated
conditions. Repeatability and reproducibility conditions are particular sets of extreme conditions.
3.20
proficiency testing
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparisons
[SOURCE: EN ISO/IEC 17043:2010, definition 3.7]
3.21
quality assurance
part of quality management focused on providing confidence that quality requirements will be fulfilled
[SOURCE: EN ISO 9000:2015, definition 3.3.6]
Note 1 to entry: A major part of quality assurance is quality control.
3.22
quality control
part of quality management focused on fulfilling quality requirements
[SOURCE: EN ISO 9000:2015, definition 3.3.7]
3.23
quantity
property of a phenomenon, body, or substance, where the property has a magnitude that can be
expressed as a number and a reference
[SOURCE: ISO/IEC Guide 99:2007, definition 1.1]
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3.24
working range
interval, being experimentally established and statistically proved by the calibration of the method,
between the lowest and highest quantity possibly measured by the method
Note 1 to entry: The lowest possible limit of a working range is the limit of quantification of an analytical
method.
3.25
reagent blank
all reagents used during the analytical process (including solvents used for extraction or dissolution)
are analysed in isolation in order to check whether they contribute to the measurement signal
Note 1 to entry: The measurement signal arising from the measurand can then be corrected accordingly.
3.26
recovery
extent to which a known, added quantity of determinant in a sample can be measured by an analytical
system
Note 1 to entry: It is calculated from the difference between results obtained from spiked and unspiked aliquots
of sample, and is usually expressed as a percentage.
[SOURCE: ISO 6107-8:1993/Amd 1:2001-12]
3.27
reference material
RM
material, sufficiently homogeneous and stable with respect to one or more specified properties, which
has been established to be fit for its intended use in a measurement process
[SOURCE: ISO Guide 30:2015, definition 2.1.1, modified – Notes to entry have not been included.]
3.28
repeatability
precision under repeatability conditions, i.e. conditions where independent test results are obtained
with the same method on identical test items in the same laboratory by the same operator using the
same equipment within short intervals of time
[SOURCE: ISO 3534-2:2006, definition 3.3.5 and 3.3.6 , modified – These definitions were combined.]
3.29
reproducibility
precision under reproducibility conditions, i.e. conditions where test results are obtained with the same
method on identical test items in different laboratories with different operators using different
equipment
[SOURCE: ISO 3534-2:2006, definition 3.3.10 and 3.3.11, modified – These definitions were combined.]
3.30
residual
difference between the observed response and that predicted by a calibration function
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3.31
robustness
measure of capacity of a procedure to remain unaffected by small, but deliberate variations in method
parameters and provides an indication of its reliability during normal usage
3.32
sample
totality of a homogeneous analysis material with an identical composition or quality (similar to term
batch)
[SOURCE: ISO/TS 20612:2007, definition 3.3]
3.33
blank sample
matrix with no measurand
Note 1 to entry: They are difficult to obtain but such materials are necessary to give a realistic estimate of
interferences that would be encountered in the analysis of test samples.
3.34
selectivity
ability of a method to determine accurately and specifically the measurand of interest in the presence of
other components in a sample matrix under the stated conditions of the test
3.35
sensitivity
change in the response of a measurand divided by the corresponding change in the stimulus
3.36
traceability
property of a measurement result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the measurement uncertainty
[SOURCE: ISO/IEC Guide 99:2007, definition 2.41]
3.37
trueness
closeness of agreement between the average value obtained from a large series of test results and an
accepted reference value
Note 1 to entry: In the present document, trueness will be expressed in terms of bias.
Note 2 to entry: Trueness should not be confused with the term ‘accuracy’ (see definition of "accuracy").
3.38
validation
verification, where the specified requirements are adequate for an intended use
[SOURCE: ISO/IEC Guide 99:2007, definition 2.45]
Note 1 to entry: This process is used to asses that a method is fit for its intended purpose. It includes:
— establishing the performance characteristics, advantages and limitations of a method and the identification of
the influences which may change these characteristics, and the extent of such changes;
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