ASTM-E2935 Standard Practice for Conducting Equivalence Testing in Laboratory Applications

ASTM-E2935 - 2017 EDITION - CURRENT
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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.

Keywords

bias equivalence; confidence interval; equivalence; equivalence limit; error-in-variables regression; means equivalence; non-inferiority; orthogonal least squares; range equivalence; slope equivalence; two one-sided tests (TOST) procedure;; ICS Number Code 03.120.30 (Application of statistical methods)

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14.02 (General Test Methods; Forensic Psychophysiology; Forensic Sciences; Terminology; Conformity Assessment; Statistical Methods; Nanotechnology; Forensic Engineering; Manufacture of Pharmaceutical Products)

To find similar documents by classification:

03.120.30 (Application of statistical methods)

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Document Number

ASTM-E2935-17

Revision Level

2017 EDITION

Status

Current

Modification Type

Revision

Publication Date

Nov. 15, 2017

Document Type

Practice

Page Count

23 pages

Committee Number

E11.20