ASTM E2161-07a

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Designation:E2161–07a
Standard Terminology Relating to
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Performance Validation in Thermal Analysis
This standard is issued under the fixed designation E 2161; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope property(ies) of which, determined by measurement is/are
certified by an identified organization and found on an
1.1 Validation of methods and apparatus is requested or
accompanying certificate.
required for quality initiatives or where results may be used for
legal purposes.
NOTE 2—Each certified value should be is accompanied by an uncer-
1.2 This standard provides terminology relating to validat- tainty at a stated level of confidence.
ing performance of thermal analysis methods and instrumen-
coefficient or variation—thestandarddeviationdividedbythe
tation. Terms that are generally understood or defined ad-
value of the parameter measured.
equately in other readily available sources are not included.
conformance—agreement of a product, process or service
1.3 The terminology described in this document is that of
with specification requirements.
the validation process and may differ from that traditionally
detection limit—the minimum quantity of analyte that can be
encountered in ASTM standards.
reliably detected but not necessarily quantified.
1.4 A definition is a single sentence with additional infor-
drift—the relatively slow change in baseline output due to
mation included in a Discussion.
instrument performance taken to be the maximum deviation
between any two points within a specified time period.
2. Terminology
figure-of-merit—a performance characteristic of a method
accuracy—the agreement between an experimentally deter-
believed to be useful when deciding its applicability for a
mined value and the accepted reference value.
specific measurement situation.
DISCUSSION—Accuracy is also known as bias in ASTM practice.
DISCUSSION—Typical figures-of-merit include accuracy, repeatability,
sensitivity, etc.
analyte—the specific component measured in an analysis.
baseline—the resultant analytical trace when no test specimen
linearity—the maximum deviation of output points from the
is present.
“best fit” linear curve to the data excluding proven outliers
blank—the measured value obtained when a specific compo-
expressed as a percentage of the full-scale computed output.
nent is not present during the measurement.
noise—the maximum amplitude, peak-to-peak, for all random
bow—the maximum deviation between an actual instrument
variations.
reading and the reading predicted by a straight line drawn
noise, short term—is that with a frequency greater than six
between upper and lower calibration points, expressed as a
cycles per min (equivalent to a period of 10 seconds or less).
percent of full scale.
DISCUSSION—ShortTerm Noise determines the smallest signal detect-
calibration—to check, adjust, or systematically standardize
able and limits the precision attainable in quantitation of low level
the gradations of a quantitative measuring signal.
measurements.
certificate—a formal document testifying to the truth of a
noise, long term—is that with a frequency between 0.6 and
matter (see also certification).
6 cycles per min (equivalent to periods of 100 and 10 s).
certification—process of issuing a formal document testifying
to the truth of a matter.
DISCUSSION—Long Term Noise may be mistaken for the response of
a test specimen.
NOTE 1—– Includes conditions (such as accreditation), materials (such
as reference materials), processes (such as calibration), and the like.
precision—the degree of agreement among or between re-
peated measurements of the same property.
certified reference material—a reference material lot, the
quantitation limit—the minimum amount that can be quanti-
fied with acceptable accuracy and precision.
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This terminology is under the jurisdiction of ASTM Committee E37 on
reference material—a material or substance, the property for
Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on
whichissufficientlyhomogeneousandwellestablishedtobe
Nomenclature and Definitions.
used for the calibration of apparatus, or the assessment of a
Current edition approved Aug. 1, 2007. Published September 2007. Originally
approved in 2001. Last previous edition approved in 2007 as E 2161–07. measurement method.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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E2161–07a
relative standard deviation—the coefficient of variation ex- standard deviation—a measure of varia
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