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What is Biocompatibility Testing for Medical Products about?

This document provides guidance on evaluating the biocompatibility of materials used in drug containers, medical devices, and implants. It discusses preclinical testing procedures to assess the safety of elastomers, plastics and polymers. Specific in vitro and in vivo tests are described to evaluate biocompatibility in patients. The procedures used to evaluate biocompatibility are categorized and various general chapters of the USP provide standards for different toxicity tests.

Author

blueflame95050

Language

EN