The model geometry was a 0.012 m diameter cylindrical nozzle with a conical collector and sudden expansion on either side of a 0.04 m long, 0.004 m diameter throat, which is able to cause hemolysis under certain flow conditions. A technical working committee designed the study, defined the model geometry and flow conditions, and identified comparison metrics. Food and Drug Administration recently completed a computational interlaboratory study to determine the suitability and methodology for simulating fluid flow in an idealized medical device. To meet this need, participants from academia, industry, and the U.S. Reliable standardized methods for this specialized need are lacking and are inhibiting the use of computational methods in the regulatory review of medical devices. While computational fluid dynamics (CFD) is commonly used for medical device development, its usefulness for demonstrating device safety has not been proven. Abstract: While computational fluid dynamics (CFD) is commonly used for medical device development, its usefulness for demonstrating device safety has not been proven.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |