Biocompatibility studies on silicone rubber

Medical grade silicone rubber has been developed for use as a material for the fabrication of medical implant devices. It has high performance, strength, elongation and very resistant to flaws and crack propagation with an excellent fatigue flex life. The toxicological/biocompatibility studies such as systemic toxicity, intracutaneous irritation, haemolysis, intramuscular implantation, rabbit pyrogen, LAL, sterility and safety tests was carried out to qualify the material and fabricated device as per international regulatory agencies. The results of the authors' experiment indicated that the material is found to be nontoxic and the device deemed to pass the mandatory biological tests.