ASTM E2161-15(2019)

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  
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-Oct-2019
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 15 (Reapproved 2019)
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 E1142 Terminology Relating to Thermophysical Properties
1.1 Validation of methods and apparatus is requested or
3. Terminology
required for quality initiatives or where results may be used for
accuracy, n—the agreement between an experimentally deter-
legal purposes.
mined value and the accepted reference value.
1.2 This standard provides terminology relating to validat-
DISCUSSION—Accuracy is also known as bias in ASTM practice.
ing performance of thermal analysis and rheology methods and
analyte, n—the specific component measured in an analysis.
instrumentation.Termsthataregenerallyunderstoodordefined
adequately in other readily available sources are not included.
baseline, n—the resultant analytical trace when no test speci-
men is present.
1.3 The terminology described in this standard is that of the
validation process and may differ from that traditionally
blank, n—the measured value obtained when a specific com-
encountered in ASTM standards.
ponent is not present during the measurement.
1.4 A definition is a single sentence with additional infor-
bow, n—the maximum deviation between an actual instrument
mation included in a Discussion.
reading and the reading predicted by a straight line drawn
1.5 Terminology commonly used in the study of precision
between upper and lower calibration points, expressed as a
and bias, in thermal analysis, rheology, and thermophysical
percent of full scale.
properties may be found in Terminologies E177, E473, and
calibration, v—to check, adjust, or systematically standardize
E1142. Additional information on method validation may be
2
the gradations of a quantitative measuring signal.
found in the U.S. Pharmacopeia and National Formulary.
certificate, n—a formal document testifying to the truth of a
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard- matter (see also certification).
ization established in the Decision on Principles for the
certification, n—process of issuing a formal document testi-
Development of International Standards, Guides and Recom-
fying to the truth of a matter.
mendations issued by the World Trade Organization Technical
DISCUSSION—Includes conditions (such as accreditation), materials
Barriers to Trade (TBT) Committee.
(such as reference materials), processes (such as calibration), and the
like.
2. Referenced Documents
certified reference material, n—a reference material lot, the
3
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.
coefficient or variation, n—the standard deviation divided by
1
This terminology is under the jurisdiction of ASTM Committee E37 on
the value of the parameter measured.
Thermal Measurements and is the direct responsibility of Subcommittee E37.03 on
Nomenclature and Definitions.
conformance, n—agreement of a product, process or service
Current edition approved Nov. 1, 2019. Published December 2019. Originally
with specification requirements.
approved in 2001. Last previous edition approved in 2015 as E2161 – 15. DOI:
10.1520/E2161-15R19.
detection limit, n—the minimum quantity of analyte that can
2
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
be reliably detected but not necessarily quantified.
Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
drift, n—the relatively slow change in baseline output due to
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
instrument performance taken to be the maximum deviation
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. between any two points within a specified time period.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2161 − 15 (2019)
figure-of-merit, n—a performance characteristic of a method relative standard deviation, n—the coeffici
...

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 E2161 − 15 (Reapproved 2019)
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 U.S.
2
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—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—analyte, n—the specific component measured in an analysis.
baseline—baseline, n—the resultant analytical trace when no test specimen is present.
blank—blank, n—the measured value obtained when a specific component is not present during the measurement.
bow—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—calibration, v—to check, adjust, or systematically standardize the gradations of a quantitative measuring signal.
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 Sept. 1, 2015Nov. 1, 2019. Published September 2015December 2019. Originally approved in 2001. Last previous edition approved in 20132015
as E2161 – 13.E2161 – 15. DOI: 10.1520/E2161-15.10.1520/E2161-15R19.
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’sstandard’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 − 15 (2019)
certificate—certificate, n—a formal document testifying to the truth of a matter (see also certification).certification).
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—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—
Each certified value should be is accompanied by an uncertainty at a stated level of confidence.
coefficient or variation—variation, n—the standard deviation divided by the value of the parameter measured.
conformance—conformance
...