ASTM E2935-13

4.1 Laboratories conducting routine testing have a continuing need to evaluate test result bias, to evaluate changes for improving the test process performance, or to validate the transfer of a test method to a new location or apparatus. In all situations it must be demonstrated that any bias or innovation will have negligible effect on test results for a characteristic of a material. This standard provides statistical methods to confirm that the mean test results from a testing process are equivalent to those from a reference standard or another testing process, where equivalence is defined as agreement within prescribed limits, termed equivalence limits.

1.1 This practice provides statistical methodology for conducting equivalence testing on numerical data from two sources to determine if their true means are similar within predetermined limits.

1.2 Applications include 1.3 The current guidance in this standard applies only to experiments conducted on a single material. Guidance is given for determining the amount of data required for an equivalence trial.

1.4 The statistical methodology for determining equivalence used is the “Two one-sided t-test” (TOST). The control of risks associated with the equivalence decision is discussed.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.