1. Biological Effect: Chronic Toxicity
2. Turnaround time: 32 weeks
3. Sample Requirements:
to be individually determined;
ISO 10993-11 (toxicity part)
These tests evaluate the potential 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)|
|Sex||20 ♀ & 20 ♂|
|Dose volume & frequency||According to ISO & FDA guidelines|
|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|