ASTM_E_1601_-_12.pdf

Designation:E160112Standard Practice forConducting an Interlaboratory Study to Evaluate thePerformance of an Analytical Method1This standard is issued under the fixed designation E1601;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers procedures and statistics for aninterlaboratory study(ILS)of the performance of an analyticalmethod.The study provides statistical values which are usefulin determining if a method is satisfactory for the purposes forwhich it was developed.These statistical values may beincorporated in the methods precision and bias section.Thispractice discusses the meaning of the statistics and what usersof analytical methods may learn from them.1.2 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E135 Terminology Relating to Analytical Chemistry forMetals,Ores,and Related MaterialsE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE1169 Practice for Conducting Ruggedness TestsE1763 Guide for Interpretation and Use of Results fromInterlaboratory Testing of Chemical Analysis Methods3.Terminology3.1 DefinitionsFor definitions of terms used in thispractice,refer to Terminology E135.3.2 Definitions of Terms Specific to This Standard:3.2.1 interlaboratory testmeasures the variability of re-sults when a test method is applied many times in a number oflaboratories.3.2.2 replicate resultsresults obtained by applying a testmethod a specified number of times to a material.3.2.3 test protocolgives instructions to each participatinglaboratory,detailing the way it is to conduct its part of theinterlaboratory test program.4.Summary of Practice4.1 Instructions are provided for planning and conducting acooperative evaluation of a proposed analytical method.4.2 The following list describes the organization of thispractice: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 understandand use the statistics found in the Precision and Bias section ofmethods.4.2.3 Sections 7 and 8 instruct the ILS coordinator andmembers of the task group on how to plan and conduct theexperimental phase of the study.4.2.4 Section 9 discusses the procedures for collecting,evaluating,and disseminating the data from the interlaboratorytest.4.2.5 Section 10 presents the statistical calculations.4.2.6 Sections 11 and 12 discuss the use of statistics toevaluate a test method and the means of incorporating the ILSstatistics into Precision and Bias statements.4.2.7 The Annex A1 gives the rationale for the calculationsin Section 10.5.Significance and Use5.1 Ideally,interlaboratory testing of a method is conductedby a randomly chosen group of laboratories that typifies thekind of laboratory that is likely to use the method.In actuality,this ideal is only approximated by the laboratories that areavailable and willing to undertake the test work.The coordi-nator of the program must ensure that every participatinglaboratory has appropriate facilities and personnel and per-forms the method exactly as written.If this goal is achieved,the statistics developed during the ILS will be adequate for1This practice is under the jurisdiction of ASTM Committee E01 on AnalyticalChemistry for Metals,Ores,and Related Materials and is the direct responsibility ofSubcommittee E01.22 on Laboratory Quality.Current edition approved Dec.15,2012.Published January 2013.Originallyapproved in 1994.Last previous edition approved in 2010 as E1601 10.DOI:10.1520/E1601-12.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 determining if the method is capable of producing satisfactoryprecision in actual use.If the program includes certifiedreference materials,the test data also provide informationconcerning the accuracy of the method.The statistics providea general guide to the expected performance of the method.6.Statistical Guide for the Users of Analytical MethodsEvaluated in Accordance With This Practice6.1 Standard Deviations(for formal definitions,refer toTerminology E135):6.1.1 Minimum Standard Deviation of Method,sMThiss