Implantation with histopathology determines the local effects of biomaterials intended for use in medical devices. This testing applies to devices that are solid/non absorbable, non-solids (porous materials, liquids, gels, pastes and particulates) or degradable and/or absorbable (which could be solid or non-solid). This test allows manufacturers to assess the impact the implanted material has on surrounding tissues.
When determining the duration that the test article will be implanted, the following should be considered: intended clinical exposure, where the device is implanted (intramuscular, subcutaneous, or bone), and how long the device takes to reach a steady state with respect to the biological response to the implanted test article.
Gross necropsy observations will be made and implant sites are harvested and prepared for pathology review. Histopathology is necessary to meet the ISO requirements. Implantation tests are performed in compliance with criteria from:
- ISO 10993-6
- ISO 10993-12
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]