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ASTM E2857-21

(Guide)

Standard Guide for Validating Analytical Methods

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 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
Historical
Publication Date
30-Nov-2021
ICS
71.040.40 - Chemical analysis
71.040.50 - Physicochemical methods of analysis
Technical Committee
E01 - Analytical Chemistry for Metals, Ores, and Related Materials
Drafting Committee
E01.22 - Laboratory Quality
Current Stage
Ref Project

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2857 − 21
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.
4
1. Scope 2.2 ISO Standard:
ISO/IEC 17025 General Requirements for the Competence
1.1 This guide describes procedures for the validation of
of Testing and Calibration Laboratories
chemical and spectrochemical analytical test methods that are
used by a metals, ores, and related materials analysis labora-
3. Terminology
tory.
3.1 Definitions—For definitions of terms used in this guide,
1.2 This guide may be applied to the validation of labora-
refer to Terminology E135.
tory developed (in-house) methods, addition of analytes to an
3.2 Definitions of Terms Specific to This Standard:
existing standard test method, variation or scope expansion of
3.2.1 validation (of an analytical method), n—confirmation,
an existing standard method, or the use of new or different
by the provision of objective evidence and examination, that a
laboratory equipment.
method meets performance requirements and is suitable for its
1.3 The suggested approaches in this guide may also be
intended use.
used to validate the implementation of standard test methods
4. Significance and Use
used routinely by laboratories of the mining, ore processing,
and metals industry.
4.1 Method validation is a process of demonstrating that the
method meets the required performance capabilities. Interna-
1.4 This international standard was developed in accor-
tional standards such as ISO/IEC 17025, certifying bodies, and
dance with internationally recognized principles on standard-
regulatory agencies require evidence that analytical methods
ization established in the Decision on Principles for the
are capable of producing valid results. This applies to labora-
Development of International Standards, Guides and Recom-
toriesusingpublishedstandardtestmethods,modifiedstandard
mendations issued by the World Trade Organization Technical
test methods, and in-house test methods.
Barriers to Trade (TBT) Committee.
4.2 Although a collaborative study is part of this guide, this
2. Referenced Documents
guidemaybeusedbyasinglelaboratoryformethodvalidation
2
when a formal collaboration study is not practical. This guide
2.1 ASTM Standards:
may also be applied before a full collaboration study to predict
E135 Terminology Relating to Analytical Chemistry for
the reliability of the method.
Metals, Ores, and Related Materials
E1601 Practice for Conducting an Interlaboratory Study to
4.3 The use of multiple validation techniques described in
Evaluate the Performance of an Analytical Method
this guide increases confidence in the validity or application of
E1763 Guide for Interpretation and Use of Results from the method.
Interlaboratory Testing of Chemical Analysis Methods
4.4 It is beyond the scope of this guide to describe fully the
3
(Withdrawn 2015)
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 Dec. 1, 2021. Published April 2022. Originally
ε1
publication, The Fitness for Purpose of Analytical Methods, A
approved in 2011. Last previous edition approved in 2021 as E2857 – 11(2021) .
DOI: 10.1520/E2857-21.
Laboratory Guide to Method Validation and Related Topics
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
(3).
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
The last approved version of this historical standard is referenced on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
www.astm.org. 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

---------------------- Page: 1 ----------------------
E2857 − 21
5. Fundamental Considerations 5.1.2 Limit of Detection (L )—The limit of detection is
D
defined as the lowest amount of analyte that can be distin-
5.1 During the process
...

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.
´1
Designation: E2857 − 11 (Reapproved 2021) E2857 − 21
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
ε NOTE—Editorial corrections were made throughout in August 2021.
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 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 requirementsRequirements for the competenceCompetence of testingTesting and calibration laborato-
riesCalibration 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 Aug. 1, 2021Dec. 1, 2021. Published August 2021April 2022. Originally approved in 2011. Last previous edition approved in 20162021 as
ε1
E2857 – 11(2016).(2021) . DOI: 10.1520/E2857-11R21E01.10.1520/E2857-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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

---------------------- Page: 1 ----------------------
E2857 − 21
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 fundamental considerations in Section 5. For a more descriptive
definition of these concepts, refer to the International Union of Pure and Applied
...

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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.  
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Standard Specification for Nickel Alloy Billets and Bars for Reforging

ABSTRACT
This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, and UNS R30556 nickel alloy billets and bars for reforging. The products shall be hot worked from ingots by rolling, forging, extruding, hammering, or pressing. The material shall conform to the chemical composition requirements prescribed by the reference material. The chemical composition of the material shall be determined by chemical analysis in accordance with test method E1473.
SCOPE
1.1 This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N10362, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, UNS N06699, and UNS R305562 billets and bars for reforging.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 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 become familiar with all hazards including those identified in the appropriate Safety Data Sheet (SDS) for this product/material as provided by the manufacturer, to establish appropriate safety, health, and environmental practices, and determine the applicability of regulatory limitations prior to use.  
1.4 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.

  • Technical specification
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  • Technical specification
    5 pages
    English language
    sale 15% off