Are the biomedical materials suitable for human implantation?
All materials of DSM Biomedical classified as products are tested for biocompatibility and biostability. The type of testing depends on the end use. Ultimately, only the FDA and foreign notified bodies can determine if a medical device made of these materials is suitable for human implantation. A variety of chronically implanted devices using BioSpan® and Bionate®, as well as Dyneema Purity®, have been approved.
