ASTM International - ASTM E2935-17

Standard Practice for Conducting Equivalence Testing in Laboratory Applications

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Organization: ASTM International
Publication Date: 1 October 2017
Status: active
Page Count: 23
ICS Code (Application of statistical methods): 03.120.30
significance And Use:

4.1 Laboratories conducting routine testing have a continuing need to make improvements in their testing processes. In these situations it must be demonstrated that any changes will neither cause... View More

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 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.

1.4 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, 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.

abstract:

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... View More

Document History

June 1, 2021
Standard Practice for Evaluating Equivalence of Two Testing Processes
4.1 Laboratories conducting routine testing have a continuing need to make improvements in their testing processes. In these situations it must be demonstrated that any changes will neither cause an...
July 1, 2020
Standard Practice for Conducting Equivalence Tests for Comparing Testing Processes
4.1 Laboratories conducting routine testing have a continuing need to make improvements in their testing processes. In these situations it must be demonstrated that any changes will neither cause an...
July 1, 2020
Standard Practice for Conducting Equivalence Tests for Comparing Testing Processes
4.1 Laboratories conducting routine testing have a continuing need to make improvements in their testing processes. In these situations it must be demonstrated that any changes will neither cause an...
ASTM E2935-17
October 1, 2017
Standard Practice for Conducting Equivalence Testing in Laboratory Applications
4.1 Laboratories conducting routine testing have a continuing need to make improvements in their testing processes. In these situations it must be demonstrated that any changes will neither cause an...
November 15, 2016
Standard Practice for Conducting Equivalence Testing in Laboratory Applications
4.1 Laboratories conducting routine testing have a continuing need to make improvements in their testing processes. In these situations it must be demonstrated that any changes will not cause an...
October 1, 2015
Standard Practice for Conducting Equivalence Testing in Laboratory Applications
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...
October 1, 2014
Standard Practice for Conducting Equivalence Testing in Laboratory Applications
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...
August 1, 2013
Standard Practice for Conducting Equivalence Testing in Laboratory Applications
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...
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