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What Does the Food and Drug Administration Require

What Does the Food and Drug Administration Require  [Pg.264]

The Food and Drug Administration (FDA) has set guidelines for the battery of tests a researcher should conduct on a new UHMWPE material before it receives approval for implantation into humans. This list represents the minimum number of tests that should be conducted individuals may want to conduct more tests on their own, and the FDA may require other tests depending on the nature of the material being considered for FDA clearance. [Pg.264]

Stage 1 tests Stage 2 tests Stage 3 test [Pg.265]

Density and porosity Infrared spectra and chemical structure  [Pg.265]




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