I’m looking for suppliers who manufacture meshes made biomaterial which meets the following spec;
Materials used in the manufacturing of the mesh will meet the biocompatibility requirements as stated in standard ISO10933-1:2003 and the FDA Blue Book Memorandum Certification of biocompatibility of the material will be obtained from the material supplier or the following biocompatibility test will be conducted in accordance with the standards and guidelines by a recognized testing laboratory:
§ Irritation or intracutaneous reactivity or intracutaneous toxicity
§ Acute systematic toxicity
Sterility requirements the device will be sterilized by Gamma ray irradiation.
Your help will be highly appreciated.