Refining the qualification process for medical materials.
This article examines the history of the use of silicone elastomers in medical devices and explains the importance of understanding a material's physical and chemical properties.  Related issues of biocompatibility testing, materials biodurability, process controls, regulation, cost, FDA master files, and expedited approval also are addressed.
Brodhagen
T W
TW
Dow Corning Corporation, Midland, MI 48686.
D049673:History, 20th Century; D006801:Humans; D008422:Materials Testing / Q000592:standards*; D012826:Silicone Elastomers / Q000737:chemistry / Q000266:history / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration