Overview

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.

Full Product Details

Author:   Jean-Pierre Boutrand (Biomatech, France)
Publisher:   Elsevier Science & Technology
Imprint:   Woodhead Publishing Ltd
Edition:   2nd edition
Weight:   0.950kg
ISBN:  

9780081026434

ISBN 10:   0081026439
Pages:   586
Publication Date:   20 November 2019
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand  
We will order this item for you from a manufactured on demand supplier.

Table of Contents

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

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Author Information

Jean-Pierre Boutrand is General Manager and Scientific Director for the European division of NAMSA (the world leading medical device evaluation company). Dr Boutrand has been involved in more than 100 public presentations and publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for ANSM (the French agency for the safety of health products).

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