ASTM F3172-15,Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices.
ASTM F3172-15 provides guidance for selecting an appropriate device size(s) and determining an appropriate sample size(s) (that is, number of samples) for design verification testing of endovascular devices. A methodology is presented to determine which device size(s) should be selected for testing to verify the device design adequately for each design input requirement (that is, test characteristic).
Once the device size(s) has been selected for verification testing per the methodology presented in Section 5, the sample size needs to be defined. The sample size justification and statistical procedures used to analyze the data are to be based on sound scientific principles and suitable for reaching ajustifiable conclusion. An insufficient sample size may lead to erroneous conclusions more often than desired.
If a predefined specification is not initially available, a comparison to a predicate or similar device may be performed to justify acceptability. It is recommended that before design verification, the predicate or similar device should be characterized and a specification limit should be defined based on that characterization. Once the specification limit is defined, either the attribute or variable testing approaches can be used toverify the design.
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