Subcutaneous Implantation

1. Biological Effect: In Vivo Tests
2. Turnaround time: to be individually determined (after approval from Local Ethics Committee)
3. Sample Requirements:

ISO

to be individually determined;

4. Animal Quantity: 6 rats
5. Duration of implantation: to be individually determined

ISO 10993-6

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.