Biocompatibility and Performance of Medical Devices

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 academiaDelivers a comprehensive overview of testing and interpreting medical device performanceExpanded 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

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