Biological Evaluation of Medical Devices, Part 10 |
Common terms and phrases
12 weeks acceptable allic materials alloy animals annex appropriate assessment Biological evaluation biological response biological testing biological tissue Biomaterials bone cell Common provisions compares considered contained control materials control specimens cylindrical depends described determined diameter dimensions dogs effects after implantation ends Evaluation of biological evaluation of medical goats grooves guinea-pigs histological implant sites implant specimens Implant Test Implantation period Implantation procedure implanted material Implants for surgery inserted intended interface International Standards items specified Journal least length long-term macroscopic medical devices mice minimal muscle NOTE observation period pigs plant Polyethylene Practice preparation rabbits rats Record reference report shall include response to implants Select Selection of test shape sheep short-term species specified in 3.4 sterilized subcutaneous tissue sufficient surface surgical technical committees techniques test and control Test animals test material test methods Test periods test specimens tissue reaction tissue response tube Wrought