ASTM E2161-15(2019) PDF

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.