
Biocompatibility and Performance of Medical Devices
Description
Key Features
- 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
Readership
Scientists and researchers in medical device technology or government agencies:
Biocompatibility scientists, regulatory affairs professionals, product development engineers, preclinical scientists, applied researchers
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. Goldenberg2 Making use of a biological safety evaluation plan
D. Parente3 Biomechanical and biochemical compatibility in innovative biomaterials
J. Huang, X. Li, and Z.X. GuoPart Two Evaluation and characterization of biocompatibility in medical devices
4 A practical approach to analytical chemistry of medical devices
D.E. Albert5 Tolerable intake values for leachables: Practical use of ISO 10993-17 standard
R.P. Brown6 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. Geertsma7 Practical approach to blood compatibility assessments: General considerations and standards
M.F. Wolf and J.M. Anderson8 Quality strategies that fasten devices access to global markets
J.A. Torfin and S. Gompertz9 Accelerating medical device biocompatibility evaluation: An industry perspective
K.P. Coleman, W.V. Christian, and W. Zhang10 Overcoming negative test results during manufacture
D. Parente11 Methods for the characterization and evaluation of drug-device combination products
A.L. LewisPart Three Testing and interpreting the performance of medical devices
12 Efficient evaluations of bone implants performances
J.-P. Boutrand13 Methods and interpretation of performance studies for dental implants
M. Dard14 Optimizing the design of preclinical safety and performance studies—Examples in soft tissues and cardio-vascular implants
E. Drevon-Gaillot, T. Blair, and G. Clermont15 Mechanical testing for soft and hard tissue implants
C. KaddickPart Four International regulation of medical devices
16 Biological evaluation and regulation of medical devices in the European Union
T. Keene17 Biological evaluation and regulation of medical devices in Japan
K. Kojima and K. Sakaguchi18 Medical device regulations in China
C. Shan and M. LiuPart Five Histopathology principles for biocompatibility and performance studies
19 Current considerations in medical device pathology
A. Alves, L. Wancket, A. Metz
Product details
- No. of pages: 586
- Language: English
- Copyright: © Woodhead Publishing 2019
- Published: November 20, 2019
- Imprint: Woodhead Publishing
- eBook ISBN: 9780081026441
- Paperback ISBN: 9780081026434
About the Editor
Jean-Pierre Boutrand
Affiliations and Expertise
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