ASTM E2857-11
(Guide)Standard Guide for Validating Analytical Methods
Standard Guide for Validating Analytical Methods
SIGNIFICANCE AND USE
Method validation is a process of demonstrating that the method meets the required performance capabilities. International standards such as ISO/IEC 17025, certifying bodies, and regulatory agencies require evidence that analytical methods are capable of producing valid results. This applies to laboratories using published standard test methods, modified standard test methods, and in-house test methods.
Although a collaborative study is part of this guide, this guide may be used by a single laboratory for method validation when a formal collaboration study is not practical. This guide may also be applied before a full collaboration study to predict the reliability of the method.
The use of multiple validation techniques described in this guide increases confidence in the validity or application of the method.
It is beyond the scope of this guide to describe fully the fundamental considerations in Section 5. For a more descriptive definition of these concepts, refer to the International Union of Pure and Applied Chemistry (IUPAC) technical report, “Harmonized Guidelines for Single Laboratory Validation of Methods of Analysis,” the IUPAC Compendium of Analytical Nomenclature (Orange Book), and the Eurachem publication, The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics.
SCOPE
1.1 This guide describes procedures for the validation of chemical and spectrochemical analytical methods of analysis that are used by a metals, ores, and related materials analysis laboratory.
1.2 This guide may be applied to the validation of laboratory developed (in-house) methods, addition of analytes to an existing standard test method, variation or scope expansion of an existing standard method, or the use of new or different laboratory equipment.
1.3 This guide may also be used to validate the implementation of standard test methods used routinely by laboratories of the mining, ore processing, and metals industry.
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Designation: E2857 − 11
StandardGuide for
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Validating Analytical Methods
This standard is issued under the fixed designation E2857; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.1 validation (of an analytical method), n—confirmation,
by the provision of objective evidence and examination, that a
1.1 This guide describes procedures for the validation of
method meets performance requirements and is suitable for its
chemical and spectrochemical analytical methods of analysis
intended use.
that are used by a metals, ores, and related materials analysis
laboratory.
4. Significance and Use
1.2 This guide may be applied to the validation of labora-
4.1 Method validation is a process of demonstrating that the
tory developed (in-house) methods, addition of analytes to an
method meets the required performance capabilities. Interna-
existing standard test method, variation or scope expansion of
tional standards such as ISO/IEC 17025, certifying bodies, and
an existing standard method, or the use of new or different
regulatory agencies require evidence that analytical methods
laboratory equipment.
are capable of producing valid results. This applies to labora-
toriesusingpublishedstandardtestmethods,modifiedstandard
1.3 This guide may also be used to validate the implemen-
test methods, and in-house test methods.
tation of standard test methods used routinely by laboratories
of the mining, ore processing, and metals industry.
4.2 Although a collaborative study is part of this guide, this
guidemaybeusedbyasinglelaboratoryformethodvalidation
2. Referenced Documents
when a formal collaboration study is not practical. This guide
may also be applied before a full collaboration study to predict
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2.1 ASTM Standards:
the reliability of the method.
E135 Terminology Relating to Analytical Chemistry for
4.3 The use of multiple validation techniques described in
Metals, Ores, and Related Materials
E1601 Practice for Conducting an Interlaboratory Study to this guide increases confidence in the validity or application of
the method.
Evaluate the Performance of an Analytical Method
E1763 Guide for Interpretation and Use of Results from
4.4 It is beyond the scope of this guide to describe fully the
Interlaboratory Testing of Chemical Analysis Methods
fundamental considerations in Section 5. For a more descrip-
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2.2 ISO Standard: tive definition of these concepts, refer to the International
Union of Pure and Applied Chemistry (IUPAC) technical
ISO/IEC 17025 General requirements for the competence of
testing and calibration laboratories report, “Harmonized Guidelines for Single Laboratory Valida-
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tion of Methods of Analysis,” the IUPAC Compendium of
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Analytical Nomenclature (Orange Book), and the Eurachem
3. Terminology
publication, The Fitness for Purpose of Analytical Methods, A
3.1 Definitions—For definitions of terms used in this guide, 6
Laboratory Guide to Method Validation and Related Topics.
refer to Terminology E135.
5. Fundamental Considerations
3.2 Definitions of Terms Specific to This Standard:
5.1 During the process of method validation, the user of an
analyticalmethodshouldapplyanumberoffundamentaltenets
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This guide is under the jurisdiction of ASTM Committee E01 on Analytical
Chemistry for Metals, Ores, and Related Materials and is the direct responsibility of
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Subcommittee E01.22 on Laboratory Quality. M. Thompson, S. Ellison, and R. Wood, “Harmonized Guidelines for Single-
Current edition approved Nov. 1, 2011. Published January 2012. DOI: 10.1520/ Laboratory Validation of Methods of Analysis,” Pure Appl. Chem., Vol 71, No. 2,
E2857–11. 2002, pp. 835-855. http://iupac.org/publications/pac
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or International Union of Pure and Applied Chemistry Compendium of Analytical
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Nomenclature: Definitive Rules 1997, http://old.iupac.org/publications/analytical_
Standards volume information, refer to the standard’s Document Summary page on compendium/
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the ASTM website. EURACHEM Guide, The Fitness for Purpose of Analytical Methods, A
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Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Laboratory Guide to Method Validation and Related Topics, LGC, Teddington,
4th Floor, New York, NY 10036, http://www.ansi.org. Middlesex, United Kingdom, 1998. www.eurachem.org
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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