Main description:

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.

Contents:

1. Device/component selection for toxicological experiments 2. Cytotoxicity 3. Sensitization 4. Irritation 5. Material-mediated pyrogenicity 6. Acute systemic toxicity 7. Repeated-exposure systemic toxicity (sub-acute, sub-chronic and chronic systemic toxicity) 8. Implantation effects 9. Hemocompatibility 10. Genotoxicity 11. Carcinogenicity 12. Reproductive toxicity 13. Toxicokinetic study 14. Data Leverage 15. Chemical characterization 16. Biological evaluation report