ASTM D6617-21 - Standard Practice for Laboratory Bias Detection Using Single Test Result from Standard Material
Standard Practice for Laboratory Bias Detection Using Single Test Result from Standard Material
| Standard number: | D6617-21 |
| Released: | 01.05.2021 |
| Status: | Active |
| Pages: | 5 |
| Section: | 05.03 |
| Keywords: | accepted reference value; bias; check standard; consensus; power of test; probability of bias detection; type I error; type II error; |
1.1 This practice covers a methodology for establishing an acceptable tolerance zone for the difference between a single result obtained for a Check Standard (CS) from a single implementation of a test method using a single measurement system at a laboratory versus its Accepted Reference Value (ARV), based on user-specified Type I error, the user-established measurement system precision for the execution of the test method, the standard error of the ARV, and a presumed hypothesis that the measurement system as operated by the laboratory in the execution of the test method is not biased.
Note 1: Throughout this practice, the term “user” refers to the user of this practice, and the term “laboratory” (see 1.1) refers to the organization or entity that is performing the test method.
1.2 For the tolerance zone established in 1.1, a methodology is presented to estimate the probability that the single test result will fall outside the zone, in the event that the presumed hypothesis is not true and there is a bias (positive or negative) of a user-specified magnitude that is deemed to be of practical concern.
1.3 This practice is intended for ASTM Committee D02 test methods that produce results on a continuous numerical scale.
1.4 This practice assumes that the normal (Gaussian) model is adequate for the description and prediction of measurement system behavior when it is in a state of statistical control.
Note 2: While this practice does not cover scenarios in which multiple results are obtained on the same CS under site precision or repeatability conditions, the statistical concepts presented are applicable. Users wishing to apply these concepts for the scenarios described are advised to consult a statistician and to reference the CS methodology described in Practice D6299.
1.5 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.