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The fatigue demonstration test program may be carried out using either theattribute or variables approach. For either approach, a robust test programfulfills the objective of unambiguously demonstrating reliability, as well as,demonstrating understanding of when and how the components could fracture. Tothis end, it is recommended that a robust test program should aim to producedata for both surviving units and fractured units.  Test planning is needed to determine sample sizes and test levels of strainto prove that the component meets the target reliability. The two risks thatmust be addressed by the test plan are 1) the risk that an unreliable componentwill pass the test, i.e., Type 1 error, or 2) the risk of a test failing for asufficiently reliable component, i.e., Type 2 error.  Test planning methods are described to design a test plan that efficientlymeets these objectives for attribute and variable approaches. The attributeapproach offers the advantage of straight forward planning and a simple output.Sample size is calculated using a well-known formula. Testing to fracture isrecommended to complement the traditional attribute testing approach toidentify the test failure modes. The variables approach is more complex to planand analyze, however it enables a greater understanding of reliability. Samplesizes and test levels of strain are determined using a simulated data strategyto provide a clear picture of possible outcomes of the test.

Heart Valve Component Fatigue Demonstration Testing Attribute and Variables Demonstration Test Planning and Sample Size Determination