Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing.
Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices.
1. Introduction - p. Page vi 2. List of Illustrations - p. Page xiii 3. List of Tables - p. Page xiv 4. Chapter 1 : Cytotoxicity - p. Page xiv 5. Chapter 2 : Sensitization - p. Page 16 6. Chapter 3 : Irritation test - p. Page 46 7. Chapter 4 : Material-mediated pyrogenicity - p. Page 52 8. Chapter 5 : Acute systemic toxicity - p. Page 65 9. Chapter 6 : Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity) - p. Page 76 10. Chapter 7 : Implantation - p. Page 82 11. Chapter 8 : Hemocompatibility - p. Page 90 12. Chapter 9 : Tests for genotoxicity - p. Page 124 13. Chapter 10 : Carcinogenicity - p. Page 139 14. Chapter 11 : Reproduction toxicity - p. Page 157 15. Chapter 12 : Toxicokinetics - p. Page 172 16. Chapter 13 : Data leverage - p. Page 186 17. Chapter 14 : Chemical characterization - p. Page 190 18. Chapter 15 : Biological evaluation report - p. Page 221 19. Index - p. Page 231
Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing.
Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices.
1. Introduction - p. Page vi 2. List of Illustrations - p. Page xiii 3. List of Tables - p. Page xiv 4. Chapter 1 : Cytotoxicity - p. Page xiv 5. Chapter 2 : Sensitization - p. Page 16 6. Chapter 3 : Irritation test - p. Page 46 7. Chapter 4 : Material-mediated pyrogenicity - p. Page 52 8. Chapter 5 : Acute systemic toxicity - p. Page 65 9. Chapter 6 : Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity) - p. Page 76 10. Chapter 7 : Implantation - p. Page 82 11. Chapter 8 : Hemocompatibility - p. Page 90 12. Chapter 9 : Tests for genotoxicity - p. Page 124 13. Chapter 10 : Carcinogenicity - p. Page 139 14. Chapter 11 : Reproduction toxicity - p. Page 157 15. Chapter 12 : Toxicokinetics - p. Page 172 16. Chapter 13 : Data leverage - p. Page 186 17. Chapter 14 : Chemical characterization - p. Page 190 18. Chapter 15 : Biological evaluation report - p. Page 221 19. Index - p. Page 231
