Biocompatibility and Performance of Medical Devices, Second Edition, brings an understanding of biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. This new edition is updated and expanded to include the very latest developments in biocompatibility and performance testing. 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 characterization 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 Presents diverse insights from experts in government, industry, and academiaDelivers a comprehensive overview of testing and interpreting medical device performanceExpanded to include new information on: managing extractables; accelerating and simplifying medical device development through screening and alternative biocompatibility methods; and quality strategies which fasten device access to market INDICE: Part I: Introduction to biocompatibility in medical devices 1. Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes 2. Challenges in biocompatibility and failure of medical devices Marie Rose Eloy and Seth J. Goldenberg 3. Biological safety evaluation planning of medical devices David M. Parente 4. Biomechanical and biochemical compatibility in innovative medical devices Z X. Guo, Jie Huang and Xiang Li Part II: Evaluation and characterization of biocompatibility in medical devices 5. A practical approach to analytical chemistry of medical devices David E. Albert 6. Allowable limits for toxic leachables: practical use of ISO 10993-17 standard Ronald P. Brown and Alan Hood 7. In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices Wim H. De Jong, Joseph Warren Carraway and Robert E. Geertsma 8. Practical approach to blood compatibility assessments: general considerations and standards Michael Wolf and James (Jim) Anderson 9. Quality strategies that fasten devices access to global markets Jacqueline A. Torfin and Steve Gompertz 10. Accelerating Medical device biocompatibility evaluation: an industry perspective Kelly P. Coleman, Xin Tang and Whitney V. Christian 11. Case study: Problem solving at the manufacturing stage David M. Parente 12. Evaluation of drug-device combination products: A translational approach Andrew Lewis Part III: Testing and interpreting the performance of medical devices 13. Efficient Evaluations of Bone Implants Performances Jean Pierre Pierre Boutrand 14. Accellerated development and translational research: Ideas and models from the dental implants field Michel Dard 15. Can preclinical performance studies accellerate soft tissues implants development? Gaelle Clermont,, Tim Blair and Elodie Drevon-Gaillot 16. Mechanical testing for soft and hard tissue implants C. Kaddick Part IV: International regulation of medical devices 17. Biological evaluation and regulation of medical devices in the European Union Adrian Keene 18. Biological evaluation and regulation of medical devices in Japan Kohichi Kojima and Keisuke Sakaguchi 19. Medical device regulations in China Change Shan and Meirong Liu Part V: Histopathology principles for biocompatibility and performance studies 20. Microscopic and ultrastructural pathology in medical devices A Alves and Lyn Miller Wancket
- ISBN: 978-0-08-102643-4
- Editorial: Woodhead Publishing
- Encuadernacion: Rústica
- Páginas: 570
- Fecha Publicación: 01/09/2019
- Nº Volúmenes: 1
- Idioma: Inglés