ASTM E1601-19
(Practice)Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
SIGNIFICANCE AND USE
5.1 Ideally, interlaboratory testing of a method is conducted by a randomly chosen group of laboratories that typifies the kind of laboratory that is likely to use the method. In actuality, this ideal is only approximated by the laboratories that are available and willing to undertake the test work. The coordinator of the program must ensure that every participating laboratory has appropriate facilities and personnel and performs the method exactly as written. If this goal is achieved, the statistics developed during the ILS will be adequate for determining if the method is capable of producing satisfactory precision in actual use. If the program includes certified reference materials, the test data also provide information concerning the bias of the method. The statistics provide a general guide to the expected performance of the method.
SCOPE
1.1 This practice covers procedures and statistics for an interlaboratory study (ILS) of the performance of an analytical method. The study provides statistical values which are useful in determining if a method is satisfactory for the purposes for which it was developed. These statistical values may be incorporated in the method's precision and bias section. This practice discusses the meaning of the statistics and what users of analytical methods may learn from them.
1.2 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.
1.3 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.
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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: E1601 − 19
Standard Practice for
Conducting an Interlaboratory Study to Evaluate the
1
Performance of an Analytical Method
This standard is issued under the fixed designation E1601; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber 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 practice covers procedures and statistics for an
E2972GuideforProduction,Testing,andValueAssignment
interlaboratory study (ILS) of the performance of an analytical
of In-House Reference Materials for Metals, Ores, and
method. The study provides statistical values which are useful
Other Related Materials
in determining if a method is satisfactory for the purposes for
which it was developed. These statistical values may be
3. Terminology
incorporated in the method’s precision and bias section. This
3.1 Definitions—For definitions of terms used in this
practice discusses the meaning of the statistics and what users
practice, refer to Terminology E135.
of analytical methods may learn from them.
3.2 Definitions of Terms Specific to This Standard:
1.2 This standard does not purport to address all of the
3.2.1 interlaboratory test—measures the variability of re-
safety concerns, if any, associated with its use. It is the
sults when a test method is applied many times in a number of
responsibility of the user of this standard to establish appro-
laboratories.
priate safety, health, and environmental practices and deter-
3.2.2 replicate results—results obtained by applying a test
mine the applicability of regulatory limitations prior to use.
method a specified number of times to a material.
1.3 This international standard was developed in accor-
3.2.3 test protocol—gives instructions to each participating
dance with internationally recognized principles on standard-
laboratory, detailing the way it is to conduct its part of the
ization established in the Decision on Principles for the
interlaboratory test program.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
4. Summary of Practice
Barriers to Trade (TBT) Committee.
4.1 Instructions are provided for planning and conducting a
cooperative evaluation of a proposed analytical method.
2. Referenced Documents
4.2 The following list describes the organization of this
2
2.1 ASTM Standards:
practice:
E135Terminology Relating to Analytical Chemistry for
4.2.1 Sections1–5 define the scope, significance and use,
Metals, Ores, and Related Materials
referenced documents, and terms used in this practice.
E177Practice for Use of the Terms Precision and Bias in
4.2.2 Section6helpsusersofanalyticalmethodsunderstand
ASTM Test Methods
andusethestatisticsfoundinthePrecisionandBiassectionof
E691Practice for Conducting an Interlaboratory Study to
methods.
Determine the Precision of a Test Method
4.2.3 Sections 7 and 8 instruct the ILS coordinator and
E1169Practice for Conducting Ruggedness Tests
members of the task group on how to plan and conduct the
E1763Guide for Interpretation and Use of Results from
experimental phase of the study.
4.2.4 Section 9 discusses the procedures for collecting,
evaluating,anddisseminatingthedatafromtheinterlaboratory
1
This practice is under the jurisdiction ofASTM Committee E01 on Analytical test.
ChemistryforMetals,Ores,andRelatedMaterialsandisthedirectresponsibilityof
4.2.5 Section 10 presents the statistical calculations.
Subcommittee E01.22 on Laboratory Quality.
4.2.6 Sections 11 and 12 discuss the use of statistics to
Current edition approved Nov. 1, 2019. Published January 2020. Originally
evaluate a test method and the means of incorporating the ILS
approved in 1994. Last previous edition approved in 2012 as E1601–12. DOI:
10.1520/E1601-19.
statistics into Precision and Bias statements.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contactASTM Customer Service at service@astm.org. ForAnnual Book ofASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
theASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E1601 − 19
4.2.7 The AnnexA1 gives the rationale for the calculations good condition; and (4) the method must be perfo
...
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: E1601 − 12 E1601 − 19
Standard Practice for
Conducting an Interlaboratory Study to Evaluate the
1
Performance of an Analytical Method
This standard is issued under the fixed designation E1601; 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 practice covers procedures and statistics for an interlaboratory study (ILS) of the performance of an analytical method.
The study provides statistical values which are useful in determining if a method is satisfactory for the purposes for which it was
developed. These statistical values may be incorporated in the method’s precision and bias section. This practice discusses the
meaning of the statistics and what users of analytical methods may learn from them.
1.2 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.3 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
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E1169 Practice for Conducting Ruggedness Tests
E1763 Guide for Interpretation and Use of Results from Interlaboratory Testing of Chemical Analysis Methods (Withdrawn
3
2015)
E2972 Guide for Production, Testing, and Value Assignment of In-House Reference Materials for Metals, Ores, and Other
Related Materials
3. Terminology
3.1 Definitions—For definitions of terms used in this practice, refer to Terminology E135.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 interlaboratory test—measures the variability of results when a test method is applied many times in a number of
laboratories.
3.2.2 replicate results—results obtained by applying a test method a specified number of times to a material.
3.2.3 test protocol—gives instructions to each participating laboratory, detailing the way it is to conduct its part of the
interlaboratory test program.
4. Summary of Practice
4.1 Instructions are provided for planning and conducting a cooperative evaluation of a proposed analytical method.
4.2 The following list describes the organization of this practice:
1
This practice 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. 15, 2012Nov. 1, 2019. Published January 2013January 2020. Originally approved in 1994. Last previous edition approved in 20102012 as
E1601 – 10.E1601–12. DOI: 10.1520/E1601-12.10.1520/E1601-19.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1601 − 19
4.2.1 Sections 1 – 5 define the scope, significance and use, referenced documents, and terms used in this practice.
4.2.2 Section 6 helps users of analytical methods understand and use the statistics found in the Precision and Bias section of
methods.
4.2.3 Sections 7 and 8 instruct the ILS coordinator and members of the task group on how to plan and conduct the experimental
phase of the study.
4.2.4 Section 9 discusses the procedures for collecting, evaluating, and disseminating the data from the interlaboratory test.
4.2.5 Section 10 presents the statistical calculations.
4.2.6 Sections 11 and 1
...
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