1、Designation: E2161 13E2161 15Standard 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 yea
2、r 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.1. Scope1.1 Validation of methods and apparatus is requested or required for quality initiatives or where results may be used
3、 for legalpurposes.1.2 This standard provides terminology relating to validating performance of thermal analysis and rheology methods andinstrumentation. Terms that are generally understood or defined adequately in other readily available sources are not included.1.3 The terminology described in thi
4、s standard is that 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, rheology,
5、 and thermophysical propertiesmay be found in Terminologies E177, E473, and E1142.Additional information on method validation may be found in the USU.S.Pharmacopeia and National Formulary, Formulary.United2States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway,Rockville, MD 20852.2. Reference
6、d Documents2.1 ASTM Standards:3E177 Practice 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
7、 the accepted reference value.DISCUSSIONAccuracy 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 m
8、easurement.bowthe maximum deviation between 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 meas
9、uring signal.certificatea formal document 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 res
10、ponsibility of Subcommittee E37.03 on Nomenclatureand Definitions.Current edition approved March 1, 2013Sept. 1, 2015. Published April 2013September 2015. Originally approved in 2001. Last previous edition approved in 20082013as E2161 08.E2161 13. DOI: 10.1520/E2161-13.10.1520/E2161-15.2 Available f
11、rom U.S. Pharmacopeial Convention (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http:/www.usp.org.3 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the stand
12、ards 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 changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accuratel
13、y, 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 official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1N
14、OTE 1 Includes conditions (such as accreditation), materials (such as reference materials), processes (such as calibration), and the like.DISCUSSIONIncludes conditions (such as accreditation), materials (such as reference materials), processes (such as calibration), and the like.certified reference
15、materiala reference 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.DISCUSSIONEach certifie
16、d value should be is accompanied by an uncertainty at a stated level of confidence.coefficient or variationthe standard deviation divided by the value of the parameter measured.conformanceagreement of a product, process or service with specification requirements.detection limitthe minimum quantity o
17、f analyte that can be reliably detected but not necessarily quantified.driftthe relatively slow change in baseline output 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 belie
18、ved to be useful when deciding its applicability for a specificmeasurement situation.DISCUSSIONTypical figures-of-merit 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 t
19、he dependent variable is equal to half of its maximum value.interlaboratory study, ILS, na study undertaken to provide 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 f
20、rom one or morematerials that are as homogeneous as practical.intralaboratory study, na study undertaken to provide within 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 out
21、liers expressedas a percentage of the full-scale computed output.noisethe maximum amplitude, peak-to-peak, for all random 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 smal
22、lest signal detectable and limits the precision attainable in quantitation of low level measurements.noise, long termis 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.precisi
23、onthe degree of agreement among or between repeated measurements of the same property.quantitation limitthe minimum amount that can be quantified with acceptable accuracy and precision.reference materiala material or substance, the property for which is sufficiently homogeneous and well established
24、to be usedfor the calibration of apparatus, or the assessment of a measurement method.relative standard deviationthe coefficient of variation expressed as a percentage.E2161 152repeatabilitya quantitative measure of the precision of the results by a single analyst in a given laboratory using a given
25、apparatus.reproducibilitya quantitative measure of the precision of the results between two laboratories.resolutiona quantitative measure of the ability to separate closely spaced transitions at an appropriate analytic level.DISCUSSIONResolution is one component of selectivity.selectivitythe ability
26、 to accurately and specifically measure the analyte in the presence of components that may be expected tobe present in the test specimen.sensitivitythe capability of methodology or instrumentation to discriminate between samples having differing concentrations orcontaining differing amounts of an an
27、alyte.DISCUSSIONDetection Limit and Quantitation Limit are indicators of sensitivity.slopethe ratio of rise (change in 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
28、 mean.standard reference materiala certified reference material, one or more properties of which have been certified by a nationalmetrology institute.NOTE 3Each certified value is should be accompanied by an uncertainty at a stated level of confidence.DISCUSSIONEach certified value is should be acco
29、mpanied 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 resolution. The shorter the time constant, the better theresolution.validation
30、the process of providing documented evidence that something does what it is intended to do.4. Keywords4.1 performance validation; rheology; terminology; thermal analysisASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin
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