1、Designation: E2161 08E2161 13Standard Terminology Relating toPerformance Validation in Thermal Analysis1This 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 or required for quality initiatives or where results may be used for legalpur
3、poses.1.2 This standard provides terminology relating to validating performance of thermal analysis methods and instrumentation.Terms that are generally understood or defined adequately in other readily available sources are not included.1.3 The terminology described in this documentstandard is that
4、 of the validation process and may differ from that traditionallyencountered in ASTM standards.1.4 A definition is a single sentence with additional information included in a Discussion.1.5 Terminology commonly used in the study of precision and bias, in thermal analysis, and thermophysical properti
5、es may befound in Terminologies E177, E473, and E1142. Additional information on method validation may be found in the USPharmacopeia and National Formulary, United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD20852.2. Referenced Documents2.1 ASTM Standards:2E177 Pract
6、ice for Use of the Terms Precision and Bias in ASTM Test MethodsE473 Terminology Relating to Thermal Analysis and RheologyE1142 Terminology Relating to Thermophysical Properties3. Terminologyaccuracythe agreement between an experimentally determined value and the accepted reference value.DISCUSSIONA
7、ccuracy is also known as bias in ASTM practice.analytethe specific component measured in an analysis.baselinethe resultant analytical trace when no test specimen is present.blankthe measured value obtained when a specific component is not present during the measurement.bowthe maximum deviation betwe
8、en an actual instrument reading and the reading predicted by a straight line drawn betweenupper and lower calibration points, expressed as a percent of full scale.calibrationto check, adjust, or systematically standardize the gradations of a quantitative measuring signal.certificatea formal document
9、 testifying to the truth of a matter (see also certification).certificationprocess of issuing a formal document testifying to the truth of a matter.1 This terminology is under the jurisdiction ofASTM Committee E37 on Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on Nom
10、enclatureand Definitions.Current edition approved May 1, 2008March 1, 2013. Published May 2008April 2013. Originally approved in 2001. Last previous edition approved in 20072008 asE2161 07a.E2161 08. DOI: 10.1520/E2161-08.10.1520/E2161-13.2 For referencedASTM standards, visit theASTM website, www.as
11、tm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what c
12、hanges have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the of
13、ficial document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1NOTE 1 Includes conditions (such as accreditation), materials (such as reference materials), processes (such as calibration), and the like.certified reference materiala r
14、eference material lot, the property(ies) of which, determined by measurement is/are certified byan identified organization and found on an accompanying certificate.NOTE 2Each certified value should be is accompanied by an uncertainty at a stated level of confidence.coefficient or variationthe standa
15、rd deviation divided by the value of the parameter measured.conformanceagreement of a product, process or service with specification requirements.detection limitthe minimum quantity of analyte that can be reliably detected but not necessarily quantified.driftthe relatively slow change in baseline ou
16、tput due to instrument performance taken to be the maximum deviation betweenany two points within a specified time period.figure-of-merita performance characteristic of a method believed to be useful when deciding its applicability for a specificmeasurement situation.DISCUSSIONTypical figures-of-mer
17、it include accuracy, repeatability, sensitivity, etc.full-width at half- maximum (FWHM), nthe difference between the two extreme values of a peak of the independent variableat which the dependent variable is equal to half of its maximum value.interlaboratory study, ILS, na study undertaken to provid
18、e between laboratory precision and accuracy information for a testmethod.interlaboratory testing, nevaluation of a test method in more than one laboratory by analyzing data obtained from one or morematerials that are as homogeneous as practical.intralaboratory study, na study undertaken to provide w
19、ithin laboratory precision and accuracy information for a test method.linearitythe maximum deviation of output points from the “best fit” linear curve to the data excluding proven outliers expressedas a percentage of the full-scale computed output.noisethe maximum amplitude, peak-to-peak, for all ra
20、ndom variations.noise, short termis that with a frequency greater than six cycles per min (equivalent to a period of 10 seconds or less).DISCUSSIONShort Term Noise determines the smallest signal detectable and limits the precision attainable in quantitation of low level measurements.noise, long term
21、is that with a frequency between 0.6 and 6 cycles per min (equivalent to periods of 100 and 10 s).DISCUSSIONLong Term Noise may be mistaken for the response of a test specimen.precisionthe degree of agreement among or between repeated measurements of the same property.quantitation limitthe minimum a
22、mount that can be quantified with acceptable accuracy and precision.reference materiala material or substance, the property for which is sufficiently homogeneous and well established to be usedfor the calibration of apparatus, or the assessment of a measurement method.relative standard deviationthe
23、coefficient of variation expressed as a percentage.repeatabilitya quantitative measure of the precision of the results by a single analyst in a given laboratory using a givenapparatus.reproducibilitya quantitative measure of the precision of the results between two laboratories.resolutiona quantitat
24、ive measure of the ability to separate closely spaced transitions at an appropriate analytic level.DISCUSSIONE2161 132Resolution is one component of selectivity.selectivitythe ability to accurately and specifically measure the analyte in the presence of components that may be expected tobe present i
25、n the test specimen.sensitivitythe capability of methodology or instrumentation to discriminate between samples having differing concentrations orcontaining differing amounts of an analyte.DISCUSSIONDetection Limit and Quantitation Limit are indicators of sensitivity.slopethe ratio of rise (change i
26、n Y-axis) to run (change in X-axis) for a linear curve or tangent to a point on a non-linear curve.standard deviationa measure of variation or scatter around the arithmetic average or mean.standard reference materiala certified reference material, one or more properties of which have been certified
27、by a nationalmetrology institute.NOTE 3Each certified value is should be accompanied by an uncertainty at a stated level of confidence.time constanta measure of the rapidity of response of a system.DISCUSSIONThe time constant is a measure of an instruments ability to respond to a signal and limits r
28、esolution. The shorter the time constant, the better theresolution.validationthe process of providing documented evidence that something does what it is intended to do.2.1 Terminology commonly used in the study of precision and bias, in thermal analysis, and thermophysical properties may befound in
29、ASTM terminology standards E177, E473, and E1142. Additional information on method validation may be found in theUS Pharmacopeia and National Formulary, United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville,MD 20852.4. Keywords4.1 performance validation; terminology; therma
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33、M 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).E2161 133
