Parts Used In Contact With Human Body

What Is Restricted Grade (short-term implant)?

Restricted grades of medical silicones are class VI materials and have the required testing performed including systemic toxicity, intracutaneous toxicity and muscle implantation. These liquid medical silicone have exhibited superior compatibility with human tissues and body fluids and an extremely low tissue response when implanted. The length of implant is generally less than 29 days although it may vary accordingly to the liquid medical silicone manufacturers. For any applications used inside the human body, a material supplier agreement should be verified for any restriction prior to fabrication. An example of the supplier agreement would be Wacker Health Care Guidelines that states the length of implant, usage responsibility, and the restrictions on certain applications such as contraceptive or reproductive devices.

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