Biological evaluation of medical devices: Évaluation biologique des dispositifs médicaux. Partie 6, Essais concernant les effets locaux après implantation. Tests for local effects after implantation
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12 weeks allic materials alloy animal tests animals and implant annex application This test autoclaving Biocompatibility Biological evaluation biological response biological testing biological tissue response Biomaterials Biomedical Materials control materials control specimens cylindrical implants diameter effects after implantation Euthanasia Evaluation of biological evaluation of medical evaluation shall take femur goats guinea-pigs histological implant sites implant specimens implantation in subcutaneous Implantation period Implantation procedure implanted material Implants for surgery implants of control include the items International Standard items specified Langeland macroscopic medical devices member bodies method for implantation number of implants observation period Polyethylene Principle Insertion PTFE quantification of degradation rabbits report shall include response The evaluation response to implants Select one species Selection of test specified in 3.3.2 specified in 3.4 specimens Common provisions sponse sterilized subcutaneous tissue surgical techniques test and control Test animals test material test methods Test periods Test specimens Common tibia tissue reaction titanium tube