ASTM E2857-22

Standard Guide for Validating Analytical Methods

SIGNIFICANCE AND USE
4.1 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.  
4.2 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.  
4.3 The use of multiple validation techniques described in this guide increases confidence in the validity or application of the method.  
4.4 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” (1), the IUPAC Compendium of Analytical Nomenclature (Orange Book) (2), and the Eurachem publication, The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics (3).
SCOPE
1.1 This guide describes procedures for the validation of chemical and spectrochemical analytical test methods 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 The suggested approaches in 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.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Mar-2022
• ICS: 71.040.40 - Chemical analysis
• ICS: 71.040.50 - Physicochemical methods of analysis
• Technical Committee: E01 - Analytical Chemistry for Metals, Ores, and Related Materials
• Drafting Committee: E01.22 - Laboratory Quality

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2857 − 22
Standard Guide for
1
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 Interlaboratory Testing of Chemical Analysis Methods
3
(Withdrawn 2015)
1.1 This guide describes procedures for the validation of
4
2.2 ISO Standard:
chemical and spectrochemical analytical test methods that are
ISO/IEC 17025 General Requirements for the Competence
used by a metals, ores, and related materials analysis labora-
of Testing and Calibration Laboratories
tory.
1.2 This guide may be applied to the validation of labora-
3. Terminology
tory developed (in-house) methods, addition of analytes to an
3.1 Definitions—For definitions of terms used in this guide,
existing standard test method, variation or scope expansion of
refer to Terminology E135.
an existing standard method, or the use of new or different
3.2 Definitions of Terms Specific to This Standard:
laboratory equipment.
3.2.1 validation (of an analytical method), n—confirmation,
1.3 The suggested approaches in this guide may also be
by the provision of objective evidence and examination, that a
used to validate the implementation of standard test methods
method meets performance requirements and is suitable for its
used routinely by laboratories of the mining, ore processing,
intended use.
and metals industry.
4. Significance and Use
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
4.1 Method validation is a process of demonstrating that the
responsibility of the user of this standard to establish appro-
method meets the required performance capabilities. Interna-
priate safety, health, and environmental practices and deter-
tional standards such as ISO/IEC 17025, certifying bodies, and
mine the applicability of regulatory limitations prior to use.
regulatory agencies require evidence that analytical methods
1.5 This international standard was developed in accor-
are capable of producing valid results. This applies to labora-
dance with internationally recognized principles on standard-
toriesusingpublishedstandardtestmethods,modifiedstandard
ization established in the Decision on Principles for the
test methods, and in-house test methods.
Development of International Standards, Guides and Recom-
4.2 Although a collaborative study is part of this guide, this
mendations issued by the World Trade Organization Technical
guidemaybeusedbyasinglelaboratoryformethodvalidation
Barriers to Trade (TBT) Committee.
when a formal collaboration study is not practical. This guide
may also be applied before a full collaboration study to predict
2. Referenced Documents
the reliability of the method.
2
2.1 ASTM Standards:
4.3 The use of multiple validation techniques described in
E135 Terminology Relating to Analytical Chemistry for
this guide increases confidence in the validity or application of
Metals, Ores, and Related Materials
the method.
E1601 Practice for Conducting an Interlaboratory Study to
Evaluate the Performance of an Analytical Method
4.4 It is beyond the scope of this guide to describe fully the
E1763 Guide for Interpretation and Use of Results from
fundamental considerations in Section 5. For a more descrip-
tive definition of these concepts, refer to the International
Union of Pure and Applied Chemistry (IUPAC) technical
1
This guide is under the jurisdiction of ASTM Committee E01 on Analytical
report, “Harmonized Guidelines for Single Laboratory Valida-
Chemistry for Metals, Ores, and Related Materials and is the direct responsibility of
tion of Methods of Analysis” (1), the IUPAC Compendium of
Subcommittee E01.22 on Laboratory Quality.
AnalyticalNomenclature(OrangeBook)(2),andtheEurachem
Current edition approved April 1, 2022. Published April 2022. Originally
approved in 2011. Last previous edition approved in 2021 as E2857 – 21. DOI:
10.1520/E2857-22.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM www.astm.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM Internati
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2857 − 21 E2857 − 22
Standard Guide for
1
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
1.1 This guide describes procedures for the validation of chemical and spectrochemical analytical test methods 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 The suggested approaches in 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.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
E135 Terminology Relating to Analytical Chemistry for Metals, Ores, and Related Materials
E1601 Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
E1763 Guide for Interpretation and Use of Results from Interlaboratory Testing of Chemical Analysis Methods (Withdrawn
3
2015)
4
2.2 ISO Standard:
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
3. Terminology
3.1 Definitions—For definitions of terms used in this guide, refer to Terminology E135.
1
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
Subcommittee E01.22 on Laboratory Quality.
Current edition approved Dec. 1, 2021April 1, 2022. Published April 2022. Originally approved in 2011. Last previous edition approved in 2021 as
ε1
E2857 – 11E2857 – 21.(2021) . DOI: 10.1520/E2857-21.10.1520/E2857-22.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2857 − 22
3.2 Definitions of Terms Specific to This Standard:
3.2.1 validation (of an analytical method), n—confirmation, by the provision of objective evidence and examination, that a method
meets performance requirements and is suitable for its intended use.
4. Significance and Use
4.1 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.
4.2 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.
4.3 The use of multiple validation techniques described in this guide increases confidence in the validity or application of the
method.
4.4 It is beyond the scope of this guide to describe fully the fund
...