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ASTM E2709 : 12

Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure

Standard Details

1.1 This practice provides a general methodology for evaluating single-stage or multiple-stage acceptance procedures which involve a quality characteristic measured on a numerical scale. This methodology computes, at a prescribed confidence level, a lower bound on the probability of passing an acceptance procedure, using estimates of the parameters of the distribution of test results from a sampled population.

1.2 For a prescribed lower probability bound, the methodology can also generate an acceptance limit table, which defines a set of test method outcomes (for example, sample averages and standard deviations) that would pass the acceptance procedure at a prescribed confidence level.

1.3 This approach may be used for demonstrating compliance with in-process, validation, or lot-release specifications.

1.4 The system of units for this practice is not specified.

1.5 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.

General Information

Status : Historical
Standard Type: Main
Document No: ASTM E2709 : 12
Document Year: 2012
Pages: 11
  • Section Volume:
  • 14.01 Volume 14.01 Healthcare Informatics
  • ICS:
  • 03.120.30 Application of statistical methods

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