1、Designation: E 2161 07aStandard Terminology Relating toPerformance Validation in Thermal Analysis1This standard is issued under the fixed designation E 2161; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision
2、. 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 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 methods and instrumen-tation. Terms that are generally understood or defined ad-equately in other readily available sources are not included.1.3 The terminology described in this document is that ofthe va
4、lidation 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.2. Terminologyaccuracythe agreement between an experimentally deter-mined value and the accepted reference value.DISCUSSION
5、Accuracy is also known as bias in ASTM practice.analytethe specific component measured in 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 betw
6、een an actual instrumentreading and the reading predicted by a straight line drawnbetween 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 t
7、estifying to the truth of amatter (see also certification).certificationprocess of issuing a formal document testifyingto the truth of a matter.NOTE 1 Includes conditions (such as accreditation), materials (suchas reference materials), processes (such as calibration), and the like.certified referenc
8、e materiala reference material lot, theproperty(ies) of which, determined by measurement is/arecertified by an identified organization and found on anaccompanying certificate.NOTE 2Each certified value should be is accompanied by an uncer-tainty at a stated level of confidence.coefficient or variati
9、onthe standard deviation divided by thevalue of the parameter measured.conformanceagreement of a product, process or servicewith specification requirements.detection limitthe minimum quantity of analyte that can bereliably detected but not necessarily quantified.driftthe relatively slow change in ba
10、seline output due toinstrument performance taken to be the maximum deviationbetween any two points 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
11、-of-merit include accuracy, repeatability,sensitivity, etc.linearitythe maximum deviation of output points from the“best fit” linear curve to the data excluding proven outliersexpressed as a percentage of the full-scale computed output.noisethe maximum amplitude, peak-to-peak, for all randomvariatio
12、ns.noise, short termis that with a frequency greater than sixcycles per min (equivalent to a period of 10 seconds or less).DISCUSSIONShort Term Noise determines the smallest signal detect-able and limits the precision attainable in quantitation of low levelmeasurements.noise, long termis that with a
13、 frequency between 0.6 and6 cycles per min (equivalent to periods of 100 and 10 s).DISCUSSIONLong Term Noise may be mistaken for the response ofa test specimen.precisionthe degree of agreement among or between re-peated measurements of the same property.quantitation limitthe minimum amount that can
14、be quanti-fied with acceptable accuracy and precision.reference materiala material or substance, the property forwhich is sufficiently homogeneous and well established to beused for the calibration of apparatus, or the assessment of ameasurement method.1This terminology is under the jurisdiction of
15、ASTM Committee E37 onThermal Measurements and is the direct responsibility of Subcommittee E37.03 onNomenclature and Definitions.Current edition approved Aug. 1, 2007. Published September 2007. Originallyapproved in 2001. Last previous edition approved in 2007 as E 216107.1Copyright ASTM Internation
16、al, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.relative standard deviationthe coefficient of variation ex-pressed as a percentage.repeatabilitya quantitative measure of the precision of theresults by a single analyst in a given laboratory using a givenapparat
17、us.reproducibilitya quantitative measure of the precision ofthe results between two laboratories.resolutiona quantitative measure of the ability to separateclosely spaced transitions at an appropriate analytic level.DISCUSSIONResolution is one component of selectivity.selectivitythe ability to accur
18、ately and specifically measurethe analyte in the presence of components that may beexpected to be present in the test specimen.sensitivitythe capability of methodology or instrumentationto discriminate between samples having differing concentra-tions or containing differing amounts of an analyte.DIS
19、CUSSIONDetection Limit and Quantitation Limit are indicatorsof sensitivity.slopethe ratio of rise (change in Y-axis) to run (change inX-axis) for a linear curve or tangent to a point on anon-linear curve.standard deviationa measure of variation or scatter aroundthe arithmetic average or mean.standar
20、d reference materiala certified reference material,one or more properties of which have been certified by anational metrology institute.NOTE 3Each certified value is should be accompanied by an uncer-tainty at a stated level of confidence.time constanta measure of the rapidity of response of asystem
21、.DISCUSSIONThe time constant is a measure of an instrumentsability to respond to a signal and limits resolution. The shorter the timeconstant, the better the resolution.validationthe process of providing documented evidencethat something does what it is intended to do.2.1 Terminology commonly used i
22、n the study of precisionand bias, in thermal analysis, and thermophysical propertiesmay be found in ASTM terminology standards E 177, E 473,and E 1142. Additional information on method validation maybe found in the US Pharmacopeia and National Formulary,United States Pharmacopeial Convention, Inc. 1
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26、ouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).E 2161 07a2
