Over deze norm
1.1 This 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.
1.2 Applications 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.
1.3 The guidance in this standard applies only to experiments conducted on a single material at a given level of the test result.
1.4 Guidance is given for determining the amount of data required for an equivalence trial. The control of risks associated with the equivalence decision is discussed.
1.5 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.
|Engelse titel||Standard Practice for Conducting Equivalence Testing in Laboratory Applications|