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...
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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.
Bibliographische Angaben
- Herausgegeben:Boutrand, Jean-Pierre
- Verlag: Woodhead Publishing
- EAN: 9780081026434
Autoren-Porträt
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).
Inhaltsverzeichnis zu „Biocompatibility and Performance of Medical Devices “
Part One Introduction to biocompatibility in medical devices 0001 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 devices4 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 devices16 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
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Histopathology principles for biocompatibility and performance studies19 Current considerations in medical device pathology A. Alves, L. Wancket, A. Metz
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