Am I correct in this assumption? If instead you are selecting samples, and performing a pass/fail test, then perhaps you might want to reference the ANSI/ASQ Z1.4 Standard on Sampling by Attributes. So, I assume you are subjecting medical devices to some accelerated testing or other, and noting the number of failures after the test duration completes. The application for the use of the above equation is as follows: select n units, subject all of them to the same test at the same time, note the number of units that fail after the test. N = ln(1-confidence level) / ln reliability For anyone looking in, the sample size for failure free testing is easily determined from the following equation: I was curious about your use of a reliability sampling plan supporting failure free testing for evaluating measures of attributes. But, I reviewed my reliability reference materials to verify the binomial distribution is correctly used in this application as it is in attributes inspection. I spotted your posting and thought, while it’s not a Six Sigma question per se, that I might be able to help anyway. I’ve spent a few years working in the med device industry supporting among others the quality management area.
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