Table 3 Guidelines of histological evaluation system of place of implantation – tissue response
From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®
Histologic feature | Score | ||||
|---|---|---|---|---|---|
0 | 1 | 2 | 3 | 4 | |
Inflammatory cell type/response — Polymorphonuclear cells — Lymphocytes | 0 | Rare, 1 to 5/hpf a | Rare,5 to 10/hpf a | Moderate infiltrate | Marked infiltrate |
Plasma cells | |||||
Macrophages/gitter cells | |||||
Multinucleated giant cells MGC) | 0 | Rare, 1 to 2/hpf | Rare, 3 to 5/hpf | ||
Necrosis | 0 | Minimal | Mild | Moderate infiltrate | Marked |
Neovascularization | 0 | Minimal capillary proliferation, focal, 1 to 3 buds | Groups of 4 to 7 capillaries with supporting fibroblastic structures | Broad band of capillaries with supporting fibroblastic structures | Extensive band of capillaries with supporting fibroblastic structures |
Fibrosis | 0 | Narrow band | Moderately thick band | Thick band | Extensive band |
Astrocytosis/fatty infiltration | |||||