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ASTM E1601-98

(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

SCOPE
1.1 This practice presents 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.

General Information

Status
Historical
Publication Date
09-May-1998
ICS
71.040.40 - Chemical analysis
Technical Committee
E01 - Analytical Chemistry for Metals, Ores, and Related Materials
Drafting Committee
E01.22 - Laboratory Quality
Current Stage
Ref Project

Relations

Replaced By
ASTM E1601-98(2003)e1 - Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
Effective Date
01-Oct-2003

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ASTM E1601-98 - Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical MethodASTM E1601-98 - Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
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ASTM E1601-98 - Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E 1601 – 98
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 (ε) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.2 interlaboratory test—measures the variability of re-
sults when a test method is applied many times in a number of
1.1 This practice presents procedures and statistics for an
laboratories.
interlaboratory study (ILS) of the performance of an analytical
3.2.3 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
3.2.4 result—the numerical value obtained by applying a
which it was developed. These statistical values may be
test method once to a material.
incorporated in the method’s precision and bias section. This
3.2.5 test method—gives directions for producing a single
practice discusses the meaning of the statistics and what users
result.
of analytical methods may learn from them.
3.2.6 test protocol—gives instructions to each participating
1.2 This standard does not purport to address all of the
laboratory, detailing the way it is to conduct its part of the
safety concerns, if any, associated with its use. It is the
interlaboratory test program.
responsibility of the user of this standard to establish appro-
3.3 Unless the test method destroys the test portion each
priate safety and health practices and determine the applica-
time it is applied, the protocol for a Plan A test specifies, if
bility of regulatory limitations prior to use.
possible, replicate results on a single test portion (which may
2. Referenced Documents be in solution). The protocol for a Plan B test specifies the
number of test portions of a material and requires duplicate
2.1 ASTM Standards:
results (2 only) on each portion (which may be in solution).
E135 Terminology Relating to Analytical Chemistry for
2
Metals, Ores, and Related Materials
4. Summary of Practice
E691 Practice for Conducting an Interlaboratory Study to
3
4.1 Instructions are provided for planning and conducting a
Determine the Precision of a Test Method
3 cooperative evaluation of a proposed analytical method.
E1169 Guide for Conducting Ruggedness Tests
4.2 The following list describes the organization of this
E1763 Guide for Interpretation and Use of Results from
4 practice:
Interlaboratory Testing of Chemical Analysis Methods
4.2.1 Sections 1-5 define the scope, significance and use,
3. Terminology referenced documents, and terms used in this practice.
4.2.2 Section6helpsusersofanalyticalmethodsunderstand
3.1 Definitions—For definitions of terms used in this prac-
andusethestatisticsfoundinthePrecisionandBiassectionof
tice, refer to Terminology E135.
methods.
3.2 Definitions of Terms Specific to This Standard:
4.2.3 Sections 7 and 8 instruct the ILS coordinator and
3.2.1 interlaboratory study (ILS)—study undertaken to as-
members of the task group on how to plan and conduct the
certainifatestmethodissuitableforitsintendeduse.TheILS
experimental phase of the study.
includes preparation, testing, and evaluation phases.
4.2.4 Section 9 discusses the procedures for collecting,
evaluating,anddisseminatingthedatafromtheinterlaboratory
test.
1
This practice is under the jurisdiction of ASTM Committee E-1 on Analytical
4.2.5 Section 10 presents the statistical calculations.
ChemistryforMetals,Ores,andRelatedMaterialsandisthedirectresponsibilityof
4.2.6 Sections 11 and 12 discuss the use of statistics to
Subcommittee E01.22 on Statistics and Quality Control.
evaluate a test method and the means of incorporating the ILS
Current edition approved Nov. 10, 1998. Published July 1998. Originally
published as E1601–94. Last previous edition E1601–95.
statistics into Precision and Bias statements.
2
Annual Book of ASTM Standards, Vol 03.05.
4.2.7 TheAnnexA1 gives the rationale for the calculations
3
Annual Book of ASTM Standards, Vol 14.02.
4 in Section 10.
Annual Book of ASTM Standards, Vol 03.06.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E 1601
5. Significance and Use should agree with those from another laboratory: First, obtain
a result under the conditions stated in 6.2, then add R to, and
5.1 Ideally,interlaboratorytestingofamethodiscarriedout
subtract R from, this result to form a concentration confidence
by a randomly
...

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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.
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