ASTM_E_2437_-_05.pdf

Designation:E 2437 05Standard Practice forDesigning and Validating Performance-Based Test Methodsfor the Analysis of Metals,Ores,and Related Materials1This standard is issued under the fixed designation E 2437;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(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers a model for designing and validat-ing performance-based,ISO 17025-compliant,standard testmethods for the instrumental chemical analysis of metals,ores,and related materials.The principles in this practice can also beapplied to the development of test methods used to determinethe composition of other materials.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:2E 135 Terminology Relating to Analytical Chemistry forMetals,Ores,and Related MaterialsE 305 Practice for Establishing and Controlling Spectro-chemical Analytical CurvesE 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE 1329 Practice for Verification and Use of Control Chartsin Spectrochemical AnalysisE 1601 Practice for Conducting an Interlaboratory Study toEvaluate the Performance of an Analytical MethodE 1621 Guide for X-Ray Emission Spectrometric AnalysisE 2027 Practice for Conducting Proficiency Tests in theChemical Analysis of Metals,Ores,and Related MaterialsE 2165 Practice for Establishing an Uncertainty Budget forthe Chemical Analysis of Metals,Ores,and RelatedMaterials2.2ISO Standards3ISO 17025 General Requirements for the Competence ofTesting and Calibration LaboratoriesISO Guide 31 Reference MaterialsContents of Certifi-cates and LabelsISO Guide 32 Calibration in Analytical Chemistry and Useof Certified Reference MaterialsISO Guide 34 General Requirements for the Competence ofReference Material Producers3.Terminology3.1 DefinitionsFor definitions of terms used in this prac-tice,refer to Terminology E 135.3.2 Definitions of Terms Specific to This Standard:3.2.1 aim interlaboratory uncertainty,nthe maximumdeviation(95%confidence)to be allowed in the design of thetotal interlaboratory uncertainty of a test method,beginningwith the preparation of a homogeneous sample and ending witha final report value to the client.3.2.2 aim uncertainty budget,nduring the development ofa standard performance-based test method,the target allocationof interlaboratory measurement uncertainty among specificcomponents of a measurement process that contribute signifi-cantly to the overall deviation.3.2.2.1 DiscussionThe target allocation is made by thetask group as described in Practice E 2165 and serves asguidance for interlaboratory test participants during methodtesting.3.2.3 interlaboratory uncertainty,nin a performancebased standard test method,the precision(95%confidence)that participating laboratories achieved during interlaboratorystudies,beginning with the preparation of a homogeneoussample and ending with a final report value to the client.3.2.4 intralaboratory uncertainty,nin a performancebased standard test method,the precision(95%confidence)that a laboratory achieves when the method is used by morethan one operator.In test methods that establish maximumallowable intralaboratory uncertainties,users must be able todemonstrate compliance with those uncertainties in order toreport that a given test result was produced using the namedmethod.3.2.5 performance based method,na test method thatdefines(1)the general approaches for sampling,sample1This 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 May 1,2005.Published July 2005.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rdSt.,4thFloor,New York,NY 10036(www.ansi.org).1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.preparation,and making measurements on a specified type ofmaterial,and(2)defines maximum allowable uncertainties foreach measured constituent over its validated concentrationrange.3.2.6 uncertainty budget,nthe allocation of intralabora-tory measurement uncertainty among specific components of ameasurement process that contribute significantly to the overalldeviation.4.Significance