ASTM E 2161 : 2023

1.1Validation of methods and apparatus is requested or required for quality initiatives or where results may be used for legal purposes.

1.2This 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.

1.3The terminology described in this standard is that of the validation process and may differ from that traditionally encountered in ASTM standards.

1.4A definition is a single sentence with additional information included in a Discussion.

1.5This 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.

1.6Terminology 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

1.7This 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.