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Biomaterials, medical devices, and combination products : biocompatibility testing and safety assessment / Shayne Cox Gad, Gad Consulting Services, Cary, North Carolina, USA, Samantha Gad-McDonald, Gad Consulting Services, Cary, North Carolina, USA.

By: Gad, Shayne C, 1948- [author.].
Contributor(s): Gad-McDonald, Samantha [author.] | Gad, Shayne C, 1948-. Safety evaluation in the development of medical devices combination products. 3rd ed.
Material type: materialTypeLabelBookPublisher: Boca Raton : CRC Press, Taylor & Francis Group, [2016]Copyright date: ?2016Description: 1 online resource (xxii, 584 pages) : illustrations.Content type: text Media type: computer Carrier type: online resourceISBN: 9781482248388 (e-book : PDF); 9781482248371 (hardback).Call number: R857.M3 G33 2016 Uniform titles: Safety evaluation in the development of medical devices combination products Subject(s): Biomedical materials -- Biocompatibility -- TestingGenre/Form: Electronic books.Online resources: Distributed by publisher. Purchase or institutional license may be required for access. Also available in print format.
Contents:
chapter 1. Safety evaluation of medical devices -- chapter 2. Regulatory aspects and strategy in medical device and biomaterials safety evaluation -- chapter 3. Road map to test selections -- chapter 4. Materials in medical device design -- chapter 5. What to test : sampling and sample preparation -- chapter 6. Cytotoxicity testing -- chapter 7. Hemocompatibility (ISO 10993-4) -- chapter 8. Local tissue tolerance -- chapter 9. Immunotoxicology (ISO 10993-20) -- chapter 10. Implantation biology and studies -- chapter 11. Acute systemic toxicity testing and device safety evaluation -- chapter 12. Genotoxicity -- chapter 13. Subchronic and chronic toxicity and reproductive and developmental toxicity -- chapter 14. Carcinogenicity -- chapter 15. Degradation products and impurities : processes in medical devices -- chapter 16. Special case devices -- chapter 17. Combination products -- chapter 18. Clinical studies for medical devices -- chapter 19. Leachables and extractables from medical devices -- chapter 20. Toxicokinetics in biomaterial and device safety evaluation -- chapter 21. Special studies -- chapter 22. Case histories and problem resolution.
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This is a completely revised and much expanded version of the third edition of Safety evaluation in the development of medical devices combination products.

Includes bibliographical references and index.

chapter 1. Safety evaluation of medical devices -- chapter 2. Regulatory aspects and strategy in medical device and biomaterials safety evaluation -- chapter 3. Road map to test selections -- chapter 4. Materials in medical device design -- chapter 5. What to test : sampling and sample preparation -- chapter 6. Cytotoxicity testing -- chapter 7. Hemocompatibility (ISO 10993-4) -- chapter 8. Local tissue tolerance -- chapter 9. Immunotoxicology (ISO 10993-20) -- chapter 10. Implantation biology and studies -- chapter 11. Acute systemic toxicity testing and device safety evaluation -- chapter 12. Genotoxicity -- chapter 13. Subchronic and chronic toxicity and reproductive and developmental toxicity -- chapter 14. Carcinogenicity -- chapter 15. Degradation products and impurities : processes in medical devices -- chapter 16. Special case devices -- chapter 17. Combination products -- chapter 18. Clinical studies for medical devices -- chapter 19. Leachables and extractables from medical devices -- chapter 20. Toxicokinetics in biomaterial and device safety evaluation -- chapter 21. Special studies -- chapter 22. Case histories and problem resolution.

YE2019 M02

Also available in print format.

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