| Stark NJ, Biocompatibility Testing & Management, Fourth Edition, Clinical Device Group Inc, Chicago, IL (2003). Perfect bound, illustrated, 350 pages. ISBN 1-889160-11-3. $250.00 US. |
This comprehensive book is written with two interlaced purposes: the first purpose 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 second purpose deals with the tests themselves, describing the basic test methods, their scientific foundation, and implementation. Click for author's information or to order.
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