Implantation Tests (ISO 10993-6)

Implant studies often provide a direct assessment of device biocompatibility. The test material is in direct contact with living tissue. After an appropriate time, the implant site is dissected and examined microscopically for tissue reaction. Implant studies are used to determine the biocompatibility of medical devices or biomaterials that come into direct contact with living tissue other than the skin (eg sutures, surgical clips, implantable devices, etc.).

These tests can evaluate devices intended for short- or long-term implantation in clinical use. Implantation techniques can be used to evaluate both absorbable and non-absorbable materials.

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