Subchronic toxicity combined with Implantation

START 5 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.

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 paramteters) & biochemistry (17 parameters) & hematology (7 parameters)
Necropsy Gross with tissue collections
Histopathology According to ISO & FDA guidelines