Biocompatibility and Performance of Medical Devices 2nd edition [Pehme köide]

Edited by (Biomatech, France)
  • Formaat: Paperback / softback, 570 pages, kõrgus x laius: 229x152 mm
  • Sari: Woodhead Publishing Series in Biomaterials
  • Ilmumisaeg: 01-Nov-2019
  • Kirjastus: Woodhead Publishing Ltd
  • ISBN-10: 0081026439
  • ISBN-13: 9780081026434
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  • Pehme köide
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  • Formaat: Paperback / softback, 570 pages, kõrgus x laius: 229x152 mm
  • Sari: Woodhead Publishing Series in Biomaterials
  • Ilmumisaeg: 01-Nov-2019
  • Kirjastus: Woodhead Publishing Ltd
  • ISBN-10: 0081026439
  • ISBN-13: 9780081026434
Teised raamatud teemal:

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
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
3. Biological safety evaluation planning of medical devices
4. Biomechanical and biochemical compatibility in innovative medical devices Part II: Evaluation and characterization of biocompatibility in medical devices
5. A practical approach to analytical chemistry of medical devices
6. Allowable limits for toxic leachables: practical use of ISO 10993-17 standard
7. In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices
8. Practical approach to blood compatibility assessments: general considerations and standards
9. Quality strategies that fasten devices access to global markets
10. Accelerating Medical device biocompatibility evaluation: an industry perspective
11. Case study: Problem solving at the manufacturing stage
12. Evaluation of drug-device combination products: A translational approach Part III: Testing and interpreting the performance of medical devices
13. Efficient Evaluations of Bone Implants Performances
14. Accellerated development and translational research: Ideas and models from the dental implants field
15. Can preclinical performance studies accellerate soft tissues implants development?
16. Mechanical testing for soft and hard tissue implants Part IV: International regulation of medical devices
17. Biological evaluation and regulation of medical devices in the European Union
18. Biological evaluation and regulation of medical devices in Japan
19. Medical device regulations in China Part V: Histopathology principles for biocompatibility and performance studies
20. Microscopic and ultrastructural pathology in medical devices
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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