1、Designation:D661713An American National StandardStandard Practice forLaboratory Bias Detection Using Single Test Result fromStandard Material1This standard is issued under the fixed designation D6617;the number immediately following the designation indicates the year oforiginal adoption or,in the ca
2、se 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.INTRODUCTIONDue to the inherent imprecision in all test methods,a laboratory cannot expect to obtain thenum
3、erically exact accepted reference value(ARV)of a check standard(CS)material every time oneis tested.Results that are reasonably close to the ARV should provide assurance that the laboratory isperforming the test method either without bias,or with a bias that is of no practical concern,hencerequiring
4、 no intervention.Results differing from the ARV by more than a certain amount,however,should lead the laboratory to take corrective action.1.Scope*1.1 This practice covers a methodology for establishing anacceptable tolerance zone for the difference between the resultobtained from a single implement
5、ation of a test method on aCheck Standard(CS)and its ARV,based on user-specifiedType I error,the user-established test method precision,thestandard error of the ARV,and a presumed hypothesis that thelaboratory is performing the test method without bias.NOTE1Throughout this practice,the term user ref
6、ers to the user ofthis practice;and the term laboratory(see 1.1)refers to the organization orentity that is performing the test method.1.2 For the tolerance zone established in 1.1,a methodologyis presented to estimate the probability that the single test resultwill fall outside the zone,in the even
7、t that there is a bias(positive or negative)of a user-specified magnitude that isdeemed to be of practical concern(that is,the presumedhypothesis is not true).1.3 This practice is intended forASTM Committee D02 testmethods that produce results on a continuous numerical scale.1.4 This practice assume
8、s that the normal(Gaussian)modelis adequate for the description and prediction of measurementsystem behavior when it is in a state of statistical control.NOTE2While this practice does not cover scenarios in which multipleresults are obtained on the same CS under site precision or repeatabilitycondit
9、ions,the statistical concepts presented are applicable.Users wishingto apply these concepts for the scenarios described are advised to consulta statistician and to reference the CS methodology described in PracticeD6299.2.Referenced Documents2.1 ASTM Standards:2D2699 Test Method for Research Octane
10、Number of Spark-Ignition Engine FuelD6299 Practice for Applying Statistical Quality Assuranceand Control Charting Techniques to Evaluate AnalyticalMeasurement System PerformanceE178 Practice for Dealing With Outlying Observations3.Terminology3.1 Definitions for accepted reference value(ARV),accuracy
11、,bias,check standard(CS),in statistical control,siteprecision,site precision standard deviation(SITE),site preci-sion conditions,repeatability conditions,and reproducibilityconditions can be found in Practice D6299.3.2 Definitions of Terms Specific to This Standard:3.2.1 acceptable tolerance zone,na
12、 numerical zonebounded inclusively by zero 6 k (k is a value based on auser-specified Type I error;is defined in 3.2.7)such that if thedifference between the result obtained from a single implemen-tation of a test method for a CS and its ARV falls inside thiszone,the presumed hypothesis that the lab
13、oratory or testingorganization is performing the test method without bias isaccepted,and the difference is attributed to normal randomvariation of the test method.Conversely,if the difference fallsoutside this zone,the presumed hypothesis is rejected.1This practice is under the jurisdiction of ASTM
14、Committee D02 on PetroleumProducts and Lubricantsand is the direct responsibility of Subcommittee D02.94 onCoordinating Subcommittee on Quality Assurance and Statistics.Current edition approved June 15,2013.Published July 2013.Originallyapproved in 2000.Last previous edition approved in 2008 as D661
15、7 08.DOI:10.1520/D6617-13.2For 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.*A Summary of Changes section appears at
16、 the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.2 consensus check standard(CCS),n a special type ofCS in which the ARV is assigned as the arithmetic average ofat least 16 non-outlying(see Practice E178 or equivalent)testresults obtained under reproducibility conditions,and theresults pass the Anderson-Darling normality test in PracticeD6299,or other statistical normality test at the 95%confi-dence level.3.