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.
ASTM E2161-23a Referenced Document
ASTM E1142 Standard Terminology Relating to Thermophysical Properties
ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
ASTM E473 Standard Terminology Relating to Thermal Analysis
ASTM E2161-23a history
2023ASTM E2161-23c Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2023ASTM E2161-23b Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2023ASTM E2161-23a Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2023ASTM E2161-23 Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2022ASTM E2161-22b Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2022ASTM E2161-22a Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2022ASTM E2161-22 Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2021ASTM E2161-21b Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2021ASTM E2161-21a Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2021ASTM E2161-21 Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2019ASTM E2161-15(2019) Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2015ASTM E2161-15 Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology
2013ASTM E2161-13 Standard Terminology Relating to Performance Validation in Thermal Analysis
2008ASTM E2161-08 Standard Terminology Relating to Performance Validation in Thermal Analysis
2007ASTM E2161-07a Standard Terminology Relating to Performance Validation in Thermal Analysis
2007ASTM E2161-07 Standard Terminology Relating to Performance Validation in Thermal Analysis
2006ASTM E2161-06a Standard Terminology Relating to Performance Validation in Thermal Analysis
2006ASTM E2161-06 Standard Terminology Relating to Performance Validation in Thermal Analysis
2001ASTM E2161-01 Standard Terminology Relating to Performance Validation in Thermal Analysis