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Biocompatibility and Performance of Medical Devices
A practical guide to all aspects of biocompatibility and performance testing of medical devices and biomaterials, including the latest developments
Jean-Pierre Boutrand (Edited by)
9780081026434, Elsevier Science
Paperback / softback, published 20 November 2019
586 pages
22.9 x 15.1 x 3.6 cm, 0.95 kg
Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies.
Part One Introduction to biocompatibility in medical devices 000 1 Strategies to accelerate medical market access and manage risks of biocompatibility R. Eloy and S.J. Goldenberg 2 Making use of a biological safety evaluation plan D. Parente 3 Biomechanical and biochemical compatibility in innovative biomaterials J. Huang, X. Li, and Z.X. Guo Part Two Evaluation and characterization of biocompatibility in medical devices 4 A practical approach to analytical chemistry of medical devices D.E. Albert 5 Tolerable intake values for leachables: Practical use of ISO 10993-17 standard R.P. Brown 6 In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices W.H. De Jong, J.W. Carraway, and R.E. Geertsma 7 Practical approach to blood compatibility assessments: General considerations and standards M.F. Wolf and J.M. Anderson 8 Quality strategies that fasten devices access to global markets J.A. Torfin and S. Gompertz 9 Accelerating medical device biocompatibility evaluation: An industry perspective K.P. Coleman, W.V. Christian, and W. Zhang 10 Overcoming negative test results during manufacture D. Parente 11 Methods for the characterization and evaluation of drug-device combination products A.L. Lewis Part Three Testing and interpreting the performance of medical devices 12 Efficient evaluations of bone implants performances J.-P. Boutrand 13 Methods and interpretation of performance studies for dental implants M. Dard 14 Optimizing the design of preclinical safety and performance studies—Examples in soft tissues and cardio-vascular implants E. Drevon-Gaillot, T. Blair, and G. Clermont 15 Mechanical testing for soft and hard tissue implants C. Kaddick Part Four International regulation of medical devices 16 Biological evaluation and regulation of medical devices in the European Union T. Keene 17 Biological evaluation and regulation of medical devices in Japan K. Kojima and K. Sakaguchi 18 Medical device regulations in China C. Shan and M. Liu Part Five Histopathology principles for biocompatibility and performance studies 19 Current considerations in medical device pathology A. Alves, L. Wancket, A. Metz
Subject Areas: Materials science [TGM], Biotechnology [TCB], Biomedical engineering [MQW]
