This comprehensive book is written in two interrelated parts.
Biocompatibility TestingThe first part deals with managing a biological safety testing function and addresses standard procedures such as determining if new testing is needed, what testing is needed, choosing extraction conditions for testing assessing risk, and dealing with positive failed) test results. The implementation of the biological safety function within a firm has not changed over the years and this part of the book is as current as when it was first written.
Biocompatibility Management
The second part addresses the tests themselves, describing the basic test methods, their scientific foundation, and implementation. This part of the book was based on new and evolving research, most of which eventually found its was into the the ISO 10993 standards. If this part were to be updated the content would not change but the references would direct the reader to the corresponding ISO standards.
Table of Contents
Biocompatibility Testing
1. History of Regulation
2. The Biology of Toxicity, Related Tests
3. More Biology of Toxicity & Related Tests
4. Sample Preparation
5. "Doing a Test"
6. Material Characterization
7. How Tissues Affect Materials: Material Degradation
8. Material-Based Testing
9. Safety Portfolios
10. Preclinical Animal Studies
Biocompatibility Management
11. Laboratory Audits
12. Quality Systems
13. Health-Based Risk Assessment
14. Dealing with Positive Test Results
