ASTM E2161-15
(Terminology)Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
SCOPE
1.1 Validation of methods and apparatus is requested or required for quality initiatives or where results may be used for legal purposes.
1.2 This standard provides terminology relating to validating performance of thermal analysis and rheology 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 standard is that of the validation process and may differ from that traditionally encountered 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, and thermophysical properties may be found in Terminologies E177, E473, and E1142. Additional information on method validation may be found in the U.S. Pharmacopeia and National Formulary.2
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Designation: E2161 − 15
Standard Terminology Relating to
1
Performance Validation in Thermal Analysis and Rheology
This standard is issued under the fixed designation E2161; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope analyte—the specific component measured in an analysis.
1.1 Validation of methods and apparatus is requested or
baseline—the resultant analytical trace when no test specimen
required for quality initiatives or where results may be used for
is present.
legal purposes.
blank—the measured value obtained when a specific compo-
1.2 This standard provides terminology relating to validat-
nent is not present during the measurement.
ing performance of thermal analysis and rheology methods and
instrumentation.Termsthataregenerallyunderstoodordefined bow—the maximum deviation between an actual instrument
adequately in other readily available sources are not included.
reading and the reading predicted by a straight line drawn
between upper and lower calibration points, expressed as a
1.3 The terminology described in this standard is that of the
percent of full scale.
validation process and may differ from that traditionally
encountered in ASTM standards.
calibration—to check, adjust, or systematically standardize
1.4 A definition is a single sentence with additional infor- the gradations of a quantitative measuring signal.
mation included in a Discussion.
certificate—a formal document testifying to the truth of a
1.5 Terminology commonly used in the study of precision
matter (see also certification).
and bias, in thermal analysis, rheology, and thermophysical
certification—process of issuing a formal document testifying
properties may be found in Terminologies E177, E473, and
to the truth of a matter.
E1142. Additional information on method validation may be
2
DISCUSSION—Includes conditions (such as accreditation), materials
found in the U.S. Pharmacopeia and National Formulary.
(such as reference materials), processes (such as calibration), and the
like.
2. Referenced Documents
3
certified reference material—a reference material lot, the
2.1 ASTM Standards:
property(ies) of which, determined by measurement is/are
E177 Practice for Use of the Terms Precision and Bias in
certified by an identified organization and found on an
ASTM Test Methods
accompanying certificate.
E473 Terminology Relating to Thermal Analysis and Rhe-
DISCUSSION—Each certified value should be is accompanied by an
ology
uncertainty at a stated level of confidence.
E1142 Terminology Relating to Thermophysical Properties
coefficient or variation—thestandarddeviationdividedbythe
3. Terminology
value of the parameter measured.
accuracy—the agreement between an experimentally deter-
conformance—agreement of a product, process or service
mined value and the accepted reference value.
with specification requirements.
DISCUSSION—Accuracy is also known as bias in ASTM practice.
detection limit—the minimum quantity of analyte that can be
reliably detected but not necessarily quantified.
1
This terminology is under the jurisdiction of ASTM Committee E37 on
Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on
drift—the relatively slow change in baseline output due to
Nomenclature and Definitions.
instrument performance taken to be the maximum deviation
Current edition approved Sept. 1, 2015. Published September 2015. Originally
approved in 2001. Last previous edition approved in 2013 as E2161 – 13. DOI:
between any two points within a specified time period.
10.1520/E2161-15.
2
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
figure-of-merit—a performance characteristic of a method
Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
believed to be useful when deciding its applicability for a
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
specific measurement situation.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
DISCUSSION—Typical figures-of-merit include accuracy, repeatability,
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. sensitivity, etc.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E2161 − 15
full-width at half- maximum (FWHM), n—the difference repeatability—a quantitative measure of the precision of the
betweenthetwoextremevaluesofapeakoftheindependent results by a single analyst in a given laboratory using a given
variable at which the dependent variable is
...
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. Because
it 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 version
of the standard as published by ASTM is to be considered the official document.
Designation: E2161 − 13 E2161 − 15
Standard Terminology Relating to
1
Performance Validation in Thermal Analysis and Rheology
This standard is issued under the fixed designation E2161; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 Validation of methods and apparatus is requested or required for quality initiatives or where results may be used for legal
purposes.
1.2 This standard provides terminology relating to validating performance of thermal analysis and rheology 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 standard is that of the validation process and may differ from that traditionally
encountered 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, and thermophysical properties
may be found in Terminologies E177, E473, and E1142. Additional information on method validation may be found in the USU.S.
2
Pharmacopeia and National Formulary, Formulary.United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway,
Rockville, MD 20852.
2. Referenced Documents
3
2.1 ASTM Standards:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E473 Terminology Relating to Thermal Analysis and Rheology
E1142 Terminology Relating to Thermophysical Properties
3. Terminology
accuracy—the agreement between an experimentally determined value and the accepted reference value.
1
This terminology is under the jurisdiction of ASTM Committee E37 on Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on Nomenclature
and Definitions.
Current edition approved March 1, 2013Sept. 1, 2015. Published April 2013September 2015. Originally approved in 2001. Last previous edition approved in 20082013
as E2161 – 08.E2161 – 13. DOI: 10.1520/E2161-13.10.1520/E2161-15.
2
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
DISCUSSION—
Accuracy is also known as bias in ASTM practice.
analyte—the specific component measured in an analysis.
baseline—the resultant analytical trace when no test specimen is present.
blank—the measured value obtained when a specific component is not present during the measurement.
bow—the maximum deviation between an actual instrument reading and the reading predicted by a straight line drawn between
upper and lower calibration points, expressed as a percent of full scale.
calibration—to check, adjust, or systematically standardize the gradations of a quantitative measuring signal.
certificate—a formal document testifying to the truth of a matter (see also certification).
certification—process of issuing a formal document testifying to the truth of a matter.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2161 − 15
NOTE 1—– Includes conditions (such as accreditation), materials (such as reference materials), processes (such as calibration), and the like.
DISCUSSION—
Includes conditions (such as accreditation), materials (such as reference materials), processes (such as calibration), and the like.
certified reference material—a reference material lot, the property(ies) of which, determined by measurement is/are certified by
an identified organization and found on an accompanying certificate.
NOTE 2—Each certified value should be is accompanied by an uncertainty at a stated level of confidence.
DISCUSSION—
Each certified value should be is accompanied by an uncertainty at a stated level of confidence.
coefficient or variation—the standard deviation divided by the value of the parameter measured.
conformance—agreement of a product, process or service with specification requirements.
detection limit—the minimum quantity of analyte that can be reliably detected but not n
...
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