Biocompatibility and Performance of Medical Devices

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

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.

• Presents diverse insights from experts in government, industry and academia
• Delivers a comprehensive overview of testing and interpreting medical device performance
• Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

Scientists and researchers in medical device technology or government agencies:

Biocompatibility scientists, regulatory affairs professionals, product development engineers, preclinical scientists, applied researchers