Biomaterials, Medical Devices, and Combination Products
eBook - PDF

Biomaterials, Medical Devices, and Combination Products

Biocompatibility Testing and Safety Assessment

  1. 588 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

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

Trusted by 375,005 students

Access to over 1.5 million titles for a fair monthly price.

Study more efficiently using our study tools.

Information

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

Frequently asked questions

Yes, you can cancel anytime from the Subscription tab in your account settings on the Perlego website. Your subscription will stay active until the end of your current billing period. Learn how to cancel your subscription
No, books cannot be downloaded as external files, such as PDFs, for use outside of Perlego. However, you can download books within the Perlego app for offline reading on mobile or tablet. Learn how to download books offline
We are an online textbook subscription service, where you can get access to an entire online library for less than the price of a single book per month. With over 1.5 million books across 990+ topics, we’ve got you covered! Learn about our mission
Look out for the read-aloud symbol on your next book to see if you can listen to it. The read-aloud tool reads text aloud for you, highlighting the text as it is being read. You can pause it, speed it up and slow it down. Learn more about Read Aloud
Yes! You can use the Perlego app on both iOS and Android devices to read anytime, anywhere — even offline. Perfect for commutes or when you’re on the go.
Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app
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 1.5 million books available in our catalogue for you to explore.