What are the sample size requirements for standard tests?

Sample size requirements are generally stated in regulatory standards. A guideline to consider is three test article and one reference (control) for hydrodynamic and durability assessment per size. Durability testing however is extended to 5 test article and one reference to fill a tester and is recommended to increase confidence. Other considerations and recommended for percutaneous valves are geometry, compliance, and deployment. We work closely with regulatory bodies to stay abreast of the latest concern so we can recommend the best matrix of test conditions.


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