Biocompatibility and Performance of Medical Devices

Content: Front Cover --
Biocompatibility and Performance of Medical Devices --
Copyright --
Dedication --
Contents --
Contributors --
Foreword --
Introduction --
Part One: Introduction to biocompatibility in medical devices --
1 Strategies to accelerate medical market access and manage risks of biocompatibility --
1.1 Introduction --
1.2 Medical device development process and significance of material selection --
1.3 Accelerating time to market --
1.4 Concept of biocompatibility and impact on market access --
1.4.1 Appraisal of biocompatibility: Safety and performance 1.4.2 Factors affecting biocompatibility --
1.4.3 Evaluation and assessment of biocompatibility --
1.5 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered --
1.5.1 Metal-on-metal implants combination --
1.5.2 Residues of solutions used for reprocessing medical devices --
1.5.3 Toxicological effects of degradation products --
1.5.4 Opacification of intraocular lenses --
1.5.5 Corrosion between adjacent devices --
1.6 Challenges in biocompatibility evaluation and novel materials --
1.6.1 Extraction conditions 1.6.2 Revisiting the design of sensitization tests --
1.6.3 Interpretation of biocompatibility test results --
1.7 Conclusion --
References --
Further reading --
2 Making use of a biological safety evaluation plan --
2.1 Introduction --
2.2 The fundamentals of safety evaluation planning --
2.3 Safety evaluation planning for biomaterials --
2.4 Developing and documenting plans --
2.5 Using safety evaluations --
2.6 Conclusion --
2.7 Sources of further information and advice --
3 Biomechanical and biochemical compatibility in innovative biomaterials --
3.1 Introduction 3.2 Selection of biomaterials --
3.3 Three generations of biomedical materials --
3.4 State-of-the-art development --
3.4.1 From biologically \"inactive\" to \"active\" --
3.4.2 Mechanical biocompatibility: Matching of stiffness --
3.4.3 Multifunctional surface modification --
3.4.4 Control of biodegradability --
3.5 Future trends --
3.5.1 Biocompatibility --
3.5.2 Biodegradability --
3.5.3 Biointerface --
3.5.4 Nanomaterials --
3.5.5 Smart responsive materials --
3.5.6 In vitro evaluation --
3.6 Conclusions --
References --
Further reading Part Two: Evaluation and characterization of biocompatibility in medical devices --
4 A practical approach to analytical chemistry of medical devices --
4.1 Introduction --
4.1.1 Risk-based analysis for biocompatibility --
4.2 The role of analytical chemistry in establishing biocompatibility --
4.2.1 More chemical characterization-Reduced biological testing --
4.2.2 The role of ISO 10993 and other international standards --
4.3 Fulfilling the requirements of ISO 10993 --
4.3.1 Bioavailability and biocompatibility --
4.3.2 Solubility and bioavailability of extractables