ASTM E2161-23c

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 This terminology only includes those terms that are included in an ASTM standard or for which some action is under consideration. It is not intended as an all-inclusive listing of terms relating to performance validation.  
1.6 Terminology commonly used in the study of precision and bias, in thermal analysis, rheology, and thermophysical properties may be found in Practice E177 and Terminologies E473 and E1142. Additional information on method validation may be found in the U.S. Pharmacopeia and National Formulary.2  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Jul-2023
• ICS: 01.040.17 - Metrology and measurement. Physical phenomena (Vocabularies)
• ICS: 17.200.01 - Thermodynamics in general
• Technical Committee: E37 - Thermal Measurements
• Drafting Committee: E37.03 - Nomenclature and Definitions

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2161 − 23c
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 2. Referenced Documents
3
2.1 ASTM Standards:
1.1 Validation of methods and apparatus is requested or
E177 Practice for Use of the Terms Precision and Bias in
required for quality initiatives or where results may be used for
ASTM Test Methods
legal purposes.
E473 Terminology Relating to Thermal Analysis and Rhe-
1.2 This standard provides terminology relating to validat-
ology
ing performance of thermal analysis and rheology methods and
E1142 Terminology Relating to Thermophysical Properties
instrumentation. Terms that are generally understood or defined
3. Terminology
adequately in other readily available sources are not included.
absolute measurement, n—an analytical measurement or
1.3 The terminology described in this standard is that of the
result in which the measured variable(s) are evaluated using
validation process and may differ from that traditionally
theoretical principles and fundamental physical constants,
encountered in ASTM standards.
without using a reference material for calibration.
1.4 A definition is a single sentence with additional infor-
accuracy, n—the agreement between an experimentally deter-
mation included in a Discussion.
mined value and the accepted reference value.
1.5 This terminology only includes those terms that are
DISCUSSION—Accuracy is also known as bias in ASTM practice.
included in an ASTM standard or for which some action is
analyte, n—the specific component measured in an analysis.
under consideration. It is not intended as an all-inclusive listing
of terms relating to performance validation.
baseline, n—the resultant analytical trace when no test speci-
men is present.
1.6 Terminology commonly used in the study of precision
and bias, in thermal analysis, rheology, and thermophysical
bias, n—a constant or systematic difference between the test
properties may be found in Practice E177 and Terminologies
results and an accepted reference value.
E473 and E1142. Additional information on method validation
blank, n—the measured value obtained when a specific com-
may be found in the U.S. Pharmacopeia and National Formu-
2 ponent is not present during the measurement.
lary.
bow, n—the maximum deviation between an actual instrument
1.7 This international standard was developed in accor-
reading and the reading predicted by a straight line drawn
dance with internationally recognized principles on standard-
between upper and lower calibration points, expressed as a
ization established in the Decision on Principles for the
percent of full scale.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
calibration, n—the act or process of determining the relation-
Barriers to Trade (TBT) Committee.
ship between a set of standard units of measurement and the
output of an instrument or test method.
DISCUSSION—Calibration is intended to improve the reproducibility
1
This terminology is under the jurisdiction of ASTM Committee E37 on and bias (accuracy) of a measurement so that results are consistent with
Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on
other measurements.
Nomenclature and Definitions.
Current edition approved Aug. 1, 2023. Published August 2023. Originally
3
approved in 2001. Last previous edition approved in 2023 as E2161 – 23b. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/E2161-23C. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
2
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook Standards volume information, refer to the standard’s Document Summary page on
Pkwy., Rockville, MD 20852-1790, http://www.usp.org. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2161 − 23c
DISCUSSION—Typical figures-of-merit include accuracy, repeatability,
certificate, n—a formal document testifying to the truth of a
sensitivity, etc.
matter (see also certification).
full-width at half-maximum (FWHM), n—the difference
certification, n—process of issuing a formal document testi-
betwe
...

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 − 23b E2161 − 23c
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 This terminology only includes those terms that are included in an ASTM standard or for which some action is under
consideration. It is not intended as an all-inclusive listing of terms relating to performance validation.
1.6 Terminology commonly used in the study of precision and bias, in thermal analysis, rheology, and thermophysical properties
may be found in Practice E177 and Terminologies E473 and E1142. Additional information on method validation may be found
2
in the U.S. Pharmacopeia and National Formulary.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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
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 June 1, 2023Aug. 1, 2023. Published June 2023August 2023. Originally approved in 2001. Last previous edition approved in 2023 as
E2161 – 23a.E2161 – 23b. DOI: 10.1520/E2161-23B.10.1520/E2161-23C.
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 [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2161 − 23c
3. Terminology
absolute measurement, n—an analytical measurement or result in which the measured variable(s) are evaluated using
theoretical principles and fundamental physical constants, without using a reference material for calibration.
accuracy, n—the agreement between an experimentally determined value and the accepted reference value.
DISCUSSION—
Accuracy is also known as bias in ASTM practice.
analyte, n—the specific component measured in an analysis.
baseline, n—the resultant analytical trace when no test specimen is present.
bias, n—a constant or systematic difference between the test results and an accepted reference value.
blank, n—the measured value obtained when a specific component is not present during the measurement.
bow, n—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, n—the act or process of determining the relationship between a set of standard units of measurement and the output
of an instrument or test method.
DISCUSSION—
Calibration is intended to improve the reproducibility and bias (accuracy) of a measurement so that results are consistent with other measurements.
certificate, n—a formal document testifying to the truth of a matter (see also certification).
certification, n—process of issuing a f
...