ASTM E2161-21

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 Practice E177 and Terminologies E473 and E1142. Additional information on method validation may be found in the U.S. Pharmacopeia and National Formulary.2  
1.6 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-Dec-2020
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 21
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 E473 Terminology Relating to Thermal Analysis and Rhe-
ology
1.1 Validation of methods and apparatus is requested or
E1142 Terminology Relating to Thermophysical Properties
required for quality initiatives or where results may be used for
legal purposes.
3. Terminology
1.2 This standard provides terminology relating to validat-
ing performance of thermal analysis and rheology methods and accuracy, n—the agreement between an experimentally deter-
instrumentation.Termsthataregenerallyunderstoodordefined mined value and the accepted reference value.
adequately in other readily available sources are not included.
DISCUSSION—Accuracy is also known as bias in ASTM practice.
1.3 The terminology described in this standard is that of the
analyte, n—the specific component measured in an analysis.
validation process and may differ from that traditionally
baseline, n—the resultant analytical trace when no test speci-
encountered in ASTM standards.
men is present.
1.4 A definition is a single sentence with additional infor-
mation included in a Discussion.
blank, n—the measured value obtained when a specific com-
ponent is not present during the measurement.
1.5 Terminology commonly used in the study of precision
and bias, in thermal analysis, rheology, and thermophysical
bow, n—the maximum deviation between an actual instrument
properties may be found in Practice E177 and Terminologies
reading and the reading predicted by a straight line drawn
E473 and E1142.Additional information on method validation
between upper and lower calibration points, expressed as a
may be found in the U.S. Pharmacopeia and National Formu-
percent of full scale.
2
lary.
calibration, n—the act or process of determining the relation-
1.6 This international standard was developed in accor-
ship between a set of standard units of measurement and the
dance with internationally recognized principles on standard-
output of an instrument or test method.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
DISCUSSION—Calibration is intended to improve the reproducibility
mendations issued by the World Trade Organization Technical
and bias (accuracy) of a measurement so that results are consistent with
Barriers to Trade (TBT) Committee.
other measurements.
certificate, n—a formal document testifying to the truth of a
2. Referenced Documents
matter (see also certification).
3
2.1 ASTM Standards:
E177 Practice for Use of the Terms Precision and Bias in certification, n—process of issuing a formal document testi-
ASTM Test Methods
fying to the truth of a matter.
DISCUSSION—Includes conditions (such as accreditation), materials
(such as reference materials), processes (such as calibration), and the
like.
1
This terminology is under the jurisdiction of ASTM Committee E37 on
Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on
certified reference material, n—a reference material lot, the
Nomenclature and Definitions.
property(ies) of which, determined by measurement is/are
Current edition approved Jan. 1, 2021. Published January 2021. Originally
approved in 2001. Last previous edition approved in 2019 as E2161 – 15 (2019). certified by an identified organization and found on an
DOI: 10.1520/E2161-21.
accompanying certificate.
2
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
DISCUSSION—Each certified value should be is accompanied by an
Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
uncertainty at a stated level of confidence.
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
coefficient of variation, n—the standard deviation divided by
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. the value of the parameter measured.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2161 − 21
conformance, n—agreement of a product, process or service to be used for the calibration of apparatus, or the assessment
with specification requirements. of a measurement method.
relative standard deviation, n—the coefficient of variation
detection limit, n—the minimum quantity o
...

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 − 15 (Reapproved 2019) E2161 − 21
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 TerminologiesPractice E177, and Terminologies E473, and E1142. Additional information on method validation
2
may be found in the U.S. Pharmacopeia and National Formulary.
1.6 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
3. Terminology
accuracy, n—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 Nov. 1, 2019Jan. 1, 2021. Published December 2019January 2021. Originally approved in 2001. Last previous edition approved in 20152019
as E2161 – 15.E2161 – 15 (2019). DOI: 10.1520/E2161-15R19.10.1520/E2161-21.
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 − 21
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.
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, v—n—to check, adjust, or systematically standardize the gradations of a quantitative measuring signal.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), processes (such as calibration), and the like.
certified reference material, n—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.
DISCUSSION—
Ea
...