1、Designation:E216115Standard Terminology Relating toPerformance Validation in Thermal Analysis and Rheology1This standard is issued under the fixed designation E2161;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last rev
2、ision.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 Validation of methods and apparatus is requested orrequired for quality initiatives or where results may be used forlegal purposes.
3、1.2 This standard provides terminology relating to validat-ing performance of thermal analysis and rheology methods andinstrumentation.Terms that are generally understood or definedadequately in other readily available sources are not included.1.3 The terminology described in this standard is that o
4、f thevalidation process and may differ from that traditionallyencountered in ASTM standards.1.4 A definition is a single sentence with additional infor-mation included in a Discussion.1.5 Terminology commonly used in the study of precisionand bias,in thermal analysis,rheology,and thermophysicalprope
5、rties may be found in Terminologies E177,E473,andE1142.Additional information on method validation may befound in the U.S.Pharmacopeia and National Formulary.22.Referenced Documents2.1 ASTM Standards:3E177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE473 Terminology Relating
6、to Thermal Analysis and Rhe-ologyE1142 Terminology Relating to Thermophysical Properties3.Terminologyaccuracythe agreement between an experimentally deter-mined value and the accepted reference value.DISCUSSIONAccuracy is also known as bias in ASTM practice.analytethe specific component measured in
7、an analysis.baselinethe resultant analytical trace when no test specimenis present.blankthe measured value obtained when a specific compo-nent is not present during the measurement.bowthe maximum deviation between an actual instrumentreading and the reading predicted by a straight line drawnbetween
8、upper and lower calibration points,expressed as apercent of full scale.calibrationto check,adjust,or systematically standardizethe gradations of a quantitative measuring signal.certificatea formal document testifying to the truth of amatter(see also certification).certificationprocess of issuing a f
9、ormal document testifyingto the truth of a matter.DISCUSSIONIncludes conditions(such as accreditation),materials(such as reference materials),processes(such as calibration),and thelike.certified reference materiala reference material lot,theproperty(ies)of which,determined by measurement is/arecerti
10、fied by an identified organization and found on anaccompanying certificate.DISCUSSIONEach certified value should be is accompanied by anuncertainty at a stated level of confidence.coefficient or variationthe standard deviation divided by thevalue of the parameter measured.conformanceagreement of a p
11、roduct,process or servicewith specification requirements.detection limitthe minimum quantity of analyte that can bereliably detected but not necessarily quantified.driftthe relatively slow change in baseline output due toinstrument performance taken to be the maximum deviationbetween any two points
12、within a specified time period.figure-of-merita performance characteristic of a methodbelieved to be useful when deciding its applicability for aspecific measurement situation.DISCUSSIONTypical figures-of-merit include accuracy,repeatability,sensitivity,etc.1This terminology is under the jurisdictio
13、n of ASTM Committee E37 onThermal Measurements and is the direct responsibility of Subcommittee E37.03 onNomenclature and Definitions.Current edition approved Sept.1,2015.Published September 2015.Originallyapproved in 2001.Last previous edition approved in 2013 as E2161 13.DOI:10.1520/E2161-15.2Avai
14、lable from U.S.Pharmacopeial Convention(USP),12601 TwinbrookPkwy.,Rockville,MD 20852-1790,http:/www.usp.org.3For 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
15、 Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 full-width at half-maximum(FWHM),nthe differencebetween the two extreme values of a peak of the independentvariable at which the dependent variable
16、is equal to half ofits maximum value.interlaboratory study,ILS,na study undertaken to providebetween laboratory precision and accuracy information for atest method.interlaboratory testing,nevaluation of a test method inmore than one laboratory by analyzing data obtained fromone or more materials that are as homogeneous as practical.intralaboratory study,na study undertaken to providewithin laboratory precision and accuracy information for atest method.linearitythe maximum deviation of output poi
