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Biological Evaluation Plan |
ISO 10993-1 |
4 |
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Chemical Characterization |
Headpace GC-MS |
ISO 10993-18 ISO 10993-17 |
8 8 8 8 4 |
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GC-MS |
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LC-MS |
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ICP-MS |
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Toxicological evaluation |
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Cytotoxicity |
MEM Elution |
ISO 10993-5 |
4 |
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Direct Contact |
4 |
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Agar Diffusion |
4 |
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Filter Diffusion |
4 |
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MTT/XTT |
4 |
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Sensitization |
GPMT |
ISO 10993-10 |
12 |
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LLNA |
6 |
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Buehler |
12 |
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Imitation |
In vitro imitation |
ISO 10993-23 |
8 |
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lntracutaneous reactivity |
4 |
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Animal Imitation Test |
4 |
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Material mediated pyrogenicity |
Material mediated |
ISO 10993-11 |
4 |
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Endotoxin LAL |
4 |
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Toxicity |
Acute Systemic Toxicity |
ISO 10993-11 |
6 |
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Subacute toxicity |
12* |
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Subchronic toxicity |
20* |
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Chronic toxicity |
32* |
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Implantation |
4 week implantation |
ISO 10993-6 |
12* |
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13 week implantation |
21 * |
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Hemocompatibility |
Hemolysis (direct & indirect) |
ISO 10993-4 |
6 |
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Coagulation |
6 |
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Platelet Activation |
6 |
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Complement Activation |
6 |
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Hematology |
6 |
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Genotoxicity |
AMES |
ISO 10993-3 ISO 10993-33 |
6 |
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MLA |
12 |
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Biological Evaluation Report |
ISO 10993-1 |
4 |
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| BIOCOMPATIBILTY STUDY | STANDARD | Tournaroud Time [week] | |
| Biological Evaluation Plan | ISO 10993-1 | 4 | |
| Chemical Characterization | Headpace GC-MS |
ISO 10993-18 ISO 10993-17 |
8 8 8 8 4 |
| GC-MS | |||
| LC-MS | |||
| ICP-MS | |||
| Toxicological evaluation | |||
| Cytotoxicity | MEM Elution | ISO 10993-5 | 4 |
| Direct Contact | 4 | ||
| Agar Diffusion | 4 | ||
| Filter Diffusion | 4 | ||
| MTT/XTT | 4 | ||
| Sensitization | GPMT | ISO 10993-10 | 12 |
| LLNA | 6 | ||
| Buehler | 12 | ||
| Imitation | In vitro imitation | ISO 10993-23 | 8 |
| lntracutaneous reactivity | 4 | ||
| Animal Imitation Test | 4 | ||
| Material mediated pyrogenicity | Material mediated pyrogenicity | ISO 10993-11 | 4 |
| Endotoxin LAL | 4 | ||
| Toxicity | Acute Systemic Toxicity | ISO 10993-11 | 6 |
| Subacute toxicity | 12* | ||
| Subchronic toxicity | 20* | ||
| Chronic toxicity | 32* | ||
| Implantation | 4 week implantation | ISO 10993-6 | 12* |
| 13 week implantation | 21 * | ||
| Hemocompatibility | Hemolysis (direct & indirect) | ISO 10993-4 | 6 |
| Coagulation | 6 | ||
| Platelet Activation | 6 | ||
| Complement Activation | 6 | ||
| Hematology | 6 | ||
| Genotoxicity | AMES | ISO 10993-3
ISO 10993-33 |
6 |
| MLA | 12 | ||
| Biological Evaluation Report | ISO 10993-1 | 4 | |