Subchronic toxicity combined with Implantation
1. Biological Effect: Subacute Toxicity
2. Turnaround time: 20 weeks
3. Sample Requirements: ISO to be individually determined;
ISO 10993-11 (toxicity part)
These tests evaluate the potential sub-chronic negative systemic effects from a single or repeated exposure to extracts of a medical device.
ISO 10993-6 (implantation part)
The purpose of the study is to evaluate the medical device for local effects on living tissue when implanted subcutaneously in rats. The bioreactivity of a test item is determined through microscopic and macroscopic through a comparison of the tissue response caused by the medical device as compared to an appropriate control material. The area of the tissue surrounding the center position of each implant will be processed and a histopathologist will process the implanted sites for histopathological evaluation.
| NORWAY RAT | |
|---|---|
| Species | Norway Rat (Rattus norvegicus) |
| Strain | Wistar Rat |
| Sex | 20 ♀ & 20 ♂ |
| Quantity | 40 |
| Duration | 90 days |
| Dose Route | Implant |
| Dose volume & frequency | According to ISO & FDA guidelines |
| Clinical Observations | Daily |
| Body Weights | Daily before injections |
| Clinical Pathology |
All groups terminal: urine tests (9 parameters) & biochemistry (17 parameters) & hematology (7 parameters) |
| Necropsy | Gross with tissue collections |
| Histopathology | According to ISO & FDA guidelines |
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