ASTM E2161-23

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: Historical
• Publication Date: 31-Mar-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)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2161 − 23
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
1.1 Validation of methods and apparatus is requested or 2.1 ASTM Standards:
required for quality initiatives or where results may be used for E177 Practice for Use of the Terms Precision and Bias in
legal purposes. ASTM Test Methods
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
adequately in other readily available sources are not included.
3. Terminology
1.3 The terminology described in this standard is that of the
accuracy, n—the agreement between an experimentally deter-
validation process and may differ from that traditionally
mined value and the accepted reference value.
encountered in ASTM standards.
DISCUSSION—Accuracy is also known as bias in ASTM practice.
1.4 A definition is a single sentence with additional infor-
analyte, n—the specific component measured in an analysis.
mation included in a Discussion.
baseline, n—the resultant analytical trace when no test speci-
1.5 This terminology only includes those terms that are
men is present.
included in an ASTM standard or for which some action is
under consideration. It is not intended as an all-inclusive listing
bias, n—a constant or systematic difference between the test
of terms relating to performance validation.
results and an accepted reference value.
1.6 Terminology commonly used in the study of precision
blank, n—the measured value obtained when a specific com-
and bias, in thermal analysis, rheology, and thermophysical
ponent is not present during the measurement.
properties may be found in Practice E177 and Terminologies
bow, n—the maximum deviation between an actual instrument
E473 and E1142. Additional information on method validation
reading and the reading predicted by a straight line drawn
may be found in the U.S. Pharmacopeia and National Formu-
2
between upper and lower calibration points, expressed as a
lary.
percent of full scale.
1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
calibration, n—the act or process of determining the relation-
ization established in the Decision on Principles for the
ship between a set of standard units of measurement and the
Development of International Standards, Guides and Recom-
output of an instrument or test method.
mendations issued by the World Trade Organization Technical
DISCUSSION—Calibration is intended to improve the reproducibility
Barriers to Trade (TBT) Committee.
and bias (accuracy) of a measurement so that results are consistent with
other measurements.
1
This terminology is under the jurisdiction of ASTM Committee E37 on certificate, n—a formal document testifying to the truth of a
Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on
matter (see also certification).
Nomenclature and Definitions.
Current edition approved April 1, 2023. Published April 2023. Originally
3
approved in 2001. Last previous edition approved in 2022 as E2161 – 22b. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/E2161-23. 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

---------------------- Page: 1 ----------------------
E2161 − 23
DISCUSSION—For example, in linear regression, when data is fit to the
certification, n—process of issuing a formal document testi-
equation Y = m X + b, where Y is the dependent variable, X is the
fying to the truth of a matter.
independent variable, m is the slope, then b is the intercept.
DISCUSSION—Includes conditions (such as accreditation), materials
(such as reference materials), processes (such as calibration), and the
interlaboratory study, ILS, n—a study undertaken to provide
like.
between laboratory precision and accuracy information for a
test method.
certified r
...

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 − 22b E2161 − 23
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 March 15, 2022April 1, 2023. Published May 2022April 2023. Originally approved in 2001. Last previous edition approved in 2022 as
E2161 – 22a.E2161 – 22b. DOI: 10.1520/E2161-22B.10.1520/E2161-23.
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 − 23
3. Terminology
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.
baseline, n—the resultant analytical trace when no test specimen is present.
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 formal document testifying to the truth of a matter.
DISCUSSION—
Includes conditions (such as accreditation), materials (such as reference materials),
...