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Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices.Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation an
Biocompatible Materials. --- Biomedical materials -- Biocompatibility -- Testing. --- Biomedical materials -- Standards. --- Biomedical materials. --- Equipment and Supplies. --- Biomedical materials --- Biomedical and Dental Materials --- Investigative Techniques --- Specialty Uses of Chemicals --- Chemicals and Drugs --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Manufactured Materials --- Technology, Industry, and Agriculture --- Chemical Actions and Uses --- Technology, Industry, Agriculture --- Materials Testing --- Biocompatible Materials --- Health & Biological Sciences --- Biomedical Engineering --- Biocompatibility --- Medical instruments and apparatus. --- Biocompatibility. --- Biological compatibility --- Biological tolerance --- Biomedical compatibility --- Biomedical tolerance --- Biotolerance --- Compatibility, Biological --- Compatibility, Biomedical --- Tolerance, Biological --- Tolerance, Biomedical --- Apparatus, Medical --- Instruments, Medical --- Medical apparatus --- Medical devices --- Medical products --- Medicine --- Biomedical engineering --- Medical supplies --- Scientific apparatus and instruments --- Apparatus --- Equipment and supplies --- Instruments
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Biomedical materials. --- Biocompatible Materials. --- Bioartificial Materials --- Hemocompatible Materials --- Biomaterials --- Bioartificial Material --- Biocompatible Material --- Biomaterial --- Hemocompatible Material --- Material, Bioartificial --- Material, Biocompatible --- Material, Hemocompatible --- Materials Testing --- Biomimetic Materials --- Regenerative Medicine --- Biocompatible materials --- Medical materials --- Medicine --- Biomedical engineering --- Materials --- Biocompatibility --- Prosthesis --- Bioartificial materials --- Hemocompatible materials --- Biomaterials (Biomedical materials)
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Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devicesDiscusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessmentDelivers a comprehensive overview of testing and interpreting medical device performance.
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