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

1. Biomedical materials
2. Biomedical materials -- Standards
3. Medical instruments and apparatus industry -- Safety measures
4. Medical instruments and apparatus industry -- Standards