ASTM E1601-10
(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
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 accuracy 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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E1601 − 10
StandardPractice 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 3.2.1 interlaboratory test—measures the variability of re-
sults when a test method is applied many times in a number of
1.1 This practice covers procedures and statistics for an
laboratories.
interlaboratory study (ILS) of the performance of an analytical
3.2.2 replicate results—results obtained by applying a test
method. The study provides statistical values which are useful
method a specified number of times to a material.
in determining if a method is satisfactory for the purposes for
which it was developed. These statistical values may be
3.2.3 test protocol—gives instructions to each participating
incorporated in the method’s precision and bias section. This
laboratory, detailing the way it is to conduct its part of the
practice discusses the meaning of the statistics and what users
interlaboratory test program.
of analytical methods may learn from them.
4. Summary of Practice
1.2 This standard does not purport to address all of the
4.1 Instructions are provided for planning and conducting a
safety concerns, if any, associated with its use. It is the
cooperative evaluation of a proposed analytical method.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
4.2 The following list describes the organization of this
bility of regulatory limitations prior to use.
practice:
4.2.1 Sections 1-5 define the scope, significance and use,
2. Referenced Documents
referenced documents, and terms used in this practice.
2
4.2.2 Section6helpsusersofanalyticalmethodsunderstand
2.1 ASTM Standards:
andusethestatisticsfoundinthePrecisionandBiassectionof
E135Terminology Relating to Analytical Chemistry for
methods.
Metals, Ores, and Related Materials
4.2.3 Sections 7 and 8 instruct the ILS coordinator and
E177Practice for Use of the Terms Precision and Bias in
members of the task group on how to plan and conduct the
ASTM Test Methods
experimental phase of the study.
E691Practice for Conducting an Interlaboratory Study to
4.2.4 Section 9 discusses the procedures for collecting,
Determine the Precision of a Test Method
evaluating,anddisseminatingthedatafromtheinterlaboratory
E1169Practice for Conducting Ruggedness Tests
test.
E1763Guide for Interpretation and Use of Results from
4.2.5 Section 10 presents the statistical calculations.
Interlaboratory Testing of Chemical Analysis Methods
4.2.6 Sections 11 and 12 discuss the use of statistics to
evaluate a test method and the means of incorporating the ILS
3. Terminology
statistics into Precision and Bias statements.
3.1 Definitions—For definitions of terms used in this
4.2.7 The AnnexA1 gives the rationale for the calculations
practice, refer to Terminology E135.
in Section 10.
3.2 Definitions of Terms Specific to This Standard:
5. Significance and Use
5.1 Ideally, interlaboratory testing of a method is conducted
1
This practice is under the jurisdiction ofASTM Committee E01 on Analytical
by a randomly chosen group of laboratories that typifies the
ChemistryforMetals,Ores,andRelatedMaterialsandisthedirectresponsibilityof
kind of laboratory that is likely to use the method. In actuality,
Subcommittee E01.22 on Laboratory Quality.
this ideal is only approximated by the laboratories that are
Current edition approved May 15, 2010. Published January 2011. Originally
ϵ1
available and willing to undertake the test work. The coordi-
approved in 1994. Last previous edition approved in 2003 as E1601–98(2003) .
DOI: 10.1520/E1601-10.
nator of the program must ensure that every participating
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
laboratory has appropriate facilities and personnel and per-
contactASTM Customer Service at service@astm.org. ForAnnual Book ofASTM
forms the method exactly as written. If this goal is achieved,
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. the statistics developed during the ILS will be adequate for
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1601 − 10
determining if the method is capable of producing satisfactory includetheresultobtainedinanotherlaboratory19timesoutof
precision in actual use. If the program includes certified 20)
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:E1601–98 (Reapproved 2003) Designation: E1601 – 10
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
´ NOTE—Caution notes were moved into the text editorially in November 2003.
1. Scope
1.1 Thispracticecoversproceduresandstatisticsforaninterlaboratorystudy(ILS)oftheperformanceofananalyticalmethod.
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 and health practices and determine the applicability of regulatory
limitations prior to use.
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
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 study (ILS)—study undertaken to ascertain if a test method is suitable for its intended use. The ILS
includes preparation, testing, and evaluation phases.
3.2.2interlaboratory test—measures the variability of results when a test method is applied many times in a number of
laboratories.
3.2.3
3.2.2 replicate results—results obtained by applying a test method a specified number of times to a material.
3.2.4result—the numerical value obtained by applying a test method once to a material.
3.2.5test method—gives directions for producing a single result.
3.2.6
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.
3.3Unless the test method destroys the test portion each time it is applied, the protocol for a Plan A test specifies, if possible,
replicate results on a single test portion (which may be in solution). The protocol for a Plan B test specifies the number of test
portions of a material and requires duplicate results (2 only) on each portion (which may be in solution).
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 Statistics and Quality Control.
Current edition approved Oct. 1, 2003. Published November 2003. Originally approved in 1994. Last previous edition approved in 1998 as E1601–98. DOI:
10.1520/E1601-98R03E01.on Laboratory Quality.
´1
Current edition approved May 15, 2010. Published January 2011. Originally approved in 1994. Last previous edition approved in 2003 as E1601–98(2003) . DOI:
10.1520/E1601-10.
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@astm.org.ForAnnualBookofASTMStandards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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E1601 – 10
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:
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 Sectio
...
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