ASTM E2935-16 PDF

Scope: 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.

ASTM E2935-16 Referenced Document

ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
ASTM E2282 Standard Guide for Defining the Test Result of a Test Method*， 2023-11-01 Update
ASTM E2586 Standard Practice for Calculating and Using Basic Statistics*， 2019-04-01 Update
ASTM E456 Standard Terminology for Relating to Quality and Statistics

2021 ASTM E2935-21 Standard Practice for Evaluating Equivalence of Two Testing Processes
2020 ASTM E2935-20e1 Standard Practice for Conducting Equivalence Tests for Comparing Testing Processes
2020 ASTM E2935-20 Standard Practice for Conducting Equivalence Tests for Comparing Testing Processes
2017 ASTM E2935-17 Standard Practice for Conducting Equivalence Testing in Laboratory Applications
2016 ASTM E2935-16 Standard Practice for Conducting Equivalence Testing in Laboratory Applications
2015 ASTM E2935-15 Standard Practice for Conducting Equivalence Testing in Laboratory Applications
2014 ASTM E2935-14 Standard Practice for Conducting Equivalence Testing in Laboratory Applications
2013 ASTM E2935-13 Standard Practice for Conducting Equivalence Testing in Laboratory Applications