Biological safety is not toxicology—it is a meeting of material science and biology. This "how-to" book explains the empirical nature of medical device safety testing and directs you, step by step, to the best approach for medical biocompatibility testing in your company. A good book for start-ups setting up a biocompatibility testing program. For more details consult our catalog.
Contents
Stark NJ, Biocompatibility Testing & Management,
Fourth Edition, Clinical Device Group Inc,
Chicago, IL (2003). Perfect
bound, illustrated, 376 pages. $250.00 US.
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. Device Biocompatibility Report
10. Preclinical Animal Studies
11. Laboratory Audits
12. Quality Systems
13. Risk Assessments
14. Dealing with Positive Results
Appendix—Safety Test Protocols