Biocompatibility Protocols for Medical Devices and Materials
- 262 pages
- English
- ePUB (mobile friendly)
- Only available on web
Biocompatibility Protocols for Medical Devices and Materials
About This Book
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.
- Explains the biocompatibility test protocols for medical devices
- Provides an overview about chemical characterization
- Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies
- Discusses the basic points needed to leverage the data from another device
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Table of contents
- Cover image
- Title page
- Table of Contents
- Copyright
- Contributors
- Author bios
- Introduction
- Chapter 1. Cytotoxicity
- Chapter 2. Sensitization
- Chapter 3. Irritation test
- Chapter 4. Material-mediated pyrogenicity
- Chapter 5. Acute systemic toxicity
- Chapter 6. Repeated-exposure systemic toxicity (subacute, subchronic, and chronic systemic toxicity)
- Chapter 7. Implantation
- Chapter 8. Hemocompatibility
- Chapter 9. Tests for genotoxicity
- Chapter 10. Carcinogenicity
- Chapter 11. Reproduction toxicity
- Chapter 12. Toxicokinetics
- Chapter 13. Data leverage
- Chapter 14. Chemical characterization
- Chapter 15. Biological evaluation report
- Index