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Implantation with Histopathology Tests

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”]

Applicable Standards

  • ISO 10993-6

Testing Locations

Study Outline

In the Implantation with Histopathology test, representative portions of the device, or the entire device, are implanted in the paravertebral muscles of live rabbits for a predetermined exposure period. Gross necropsy observations will be made and implant sites harvested and fixed. Microscopic evaluation will include: cell type, cell distribution, fibroplasia, and neovascularization.

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