The Implantation with Histopathology test determines the local pathological effects of an implanted device. This test allows manufacturers to assess the impact the implanted material has on surrounding tissue and major body organs. Histopathology is necessary to meet the ISO requirements. Implantation tests comply with ISO 10993-6.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]
- ISO 10993-6