Medical Device Directory

Toxicology / Biocompatibility Testing

Available from Geneva Laboratories

Plastics and other polymers intended for use in medical devices, implants or other systems associated with a medical process, must be shown to be suitable for use in the intended applications. USP <88> Biological Reactivity Tests, in Vivo offers guidance to the testing required to meet the individual classification sought. Through exposure to different extract vehicles at different temperatures, the response of the material defines the level of classification and is directly related to the intended use of the material.

The test methods designated for use in the classification of plastics, elastomers, or other polymers are Systemic Injection, Intracutaneous Injection, and Implantation.

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