Biomaterials, Medical Devices, and Combination Products
eBook - PDF

Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment

  1. 606 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment

About this book

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

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Yes, you can access Biomaterials, Medical Devices, and Combination Products by Shayne Cox Gad,Samantha Gad-McDonald in PDF and/or ePUB format, as well as other popular books in Medicine & Biotechnology in Medicine. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2015
Print ISBN
9781482248371
eBook ISBN
9781482248388
Edition
1
Topic
Medicine
Subtopic
Biotechnology in Medicine

Table of contents

  1. Front Cover
  2. Contents
  3. Preface
  4. Authors
  5. Chapter 1: Safety Evaluation of Medical Devices
  6. Chapter 2: Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation
  7. Chapter 3: Road Map to Test Selections
  8. Chapter 4: Materials in Medical Device Design
  9. Chapter 5: What to Test : Sampling and Sample Preparation
  10. Chapter 6: Cytotoxicity Testing
  11. Chapter 7: Hemocompatibility (ISO 10993-4)
  12. Chapter 8: Local Tissue Tolerance
  13. Chapter 9: Immunotoxicology (ISO 10993-20)
  14. Chapter 10: Implantation Biology and Studies
  15. Chapter 11: Acute Systemic Toxicity Testing and Device Safety Evaluation
  16. Chapter 12: Genotoxicity
  17. Chapter 13: Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity
  18. Chapter 14: Carcinogenicity
  19. Chapter 15: Degradation Products and Impurities : Processes in Medical Devices
  20. Chapter 16: Special Case Devices
  21. Chapter 17: Combination Products
  22. Chapter 18: Clinical Studies for Medical Devices
  23. Chapter 19: Leachables and Extractables from Medical Devices
  24. Chapter 20: Toxicokinetics in Biomaterial and Device Safety Evaluation
  25. Chapter 21: Special Studies
  26. Chapter 22: Case Histories and Problem Resolution
  27. Appendix A: Selected Regulatory and Toxicological Acronyms
  28. Appendix B: Contract Testing Laboratories
  29. Appendix C: Notable Regulatory Internet Addresses
  30. Appendix D: Non-U.S. Medical Device Regulators
  31. Appendix E: Definition of Terms and Lexicon of “Clinical” Observations in Nonclinical (Animal) Studies
  32. Back Cover