Full Description

1.1This practice provides statistical methodology for conducting equivalence testing on numerical data from two sources to determine if their true means or variances differ by no more than predetermined limits.

1.2Applications include (1) equivalence testing 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.

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

1.4Guidance is given for determining the amount of data required for an equivalence trial. The control of risks associated with the equivalence decision is discussed.

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

1.6This 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.

1.7This 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.