ASTM E2935-21

1.1 This practice provides statistical methodology for conducting equivalence studies on numerical data from two sources of test results to determine if their true means, variances, or other parameters differ by no more than predetermined limits.

1.2 Applications include (1) equivalence studies for bias against an accepted reference value, (2) determining means equivalence of two test methods, test apparatus, instruments, reagent sources, or operators within a laboratory or equivalence of two laboratories in a method transfer, and (3) determining non-inferiority of a modified test procedure versus a current test procedure with respect to a performance characteristic.

1.3 The guidance in this standard applies to experiments conducted either on a single material at a given level of the test result or on multiple materials covering a selected range of test results.

1.4 Guidance is given for determining the amount of data required for an equivalence study. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

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.