A number in parentheses indicates the year of last reapproval. For this multiple-stage test, the procedurecomputes a lower bound on the probability of passing the UDUtest, based on statistical estimates made at a prescribedconfidence level from a sample of dosage units. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use. Referenced Documents2.
|Published (Last):||24 June 2015|
|PDF File Size:||8.81 Mb|
|ePub File Size:||4.70 Mb|
|Price:||Free* [*Free Regsitration Required]|
A number in parentheses indicates the year of last reapproval. Asuperscript epsilon indicates an editorial change since the last revision or reapproval.
This methodology computes, at a prescribed confidencelevel, a lower bound on the probability of passing an accep-tance procedure, using estimates of the parameters of thedistribution of test results from a sampled population.
It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.
Referenced Documents2. Significance and Use4. Current edition approved Oct. Published October Originallyapproved in Last previous edition approved in as E — United States1such as the average, standard deviation, or coefficient ofvariation relative standard deviation. If this is not the case then there can beno guarantee that the probability estimates would be validpredictions of future process performance.
A computer program is normally required toproduce the acceptable parameter region and the acceptancelimits. Thisdefines the acceptable parameter region. Thesize of sample to be taken, n, and the statistics to be used, mustbe predetermined see 5.
The acceptance limits lie on the contour ofthe acceptance region. The larger the sample size nthat is chosen, the larger will be the acceptance region and thetighter the distribution of the statistics.
Choose n so that theprobability of passing acceptance limits is greater than apredetermined value. Compute statistics for the sample. Procedures for Sampling from a Normal Distribution6. Particularinstructions for that case are given in this section, for twosampling methods, simple random and two-stage.
In thisstandard these sampling methods are denoted Sampling Plan 1and Sampling Plan 2, respectively. Llocations are selected andfrom each of them a subsample of n items is taken. When there are L locations withsubsamples of n items, the mean squares between locations andwithin locations, MSLand MSE, have L-1 and Ln-1 degreesof freedom respectively. Express the overall confidence levelas a product of confidence levels for the population mean andstandard deviation as in 6.
An acceptanceFIG. An acceptance limit table isshown for a sample size of Anacceptance limit table is shown for a sample size of 4 taken ateach of 15 locations for a total of 60 units tested. CriterionPass if all 5 individual units are between 95 and ;otherwise, fail. See 6.