Refining the qualification process for medical materials.

T W Brodhagen

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PubMed · 10147989

Refining the qualification process for medical materials.

T W Brodhagen

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Abstract

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.

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History, 20th Century Humans Materials Testing Silicone Elastomers United States United States Food and Drug Administration Historical Article Journal Article Review

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T W Brodhagen. 1991. Refining the qualification process for medical materials.. https://pubmed.ncbi.nlm.nih.gov/10147989/

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