Biocompatibility and performance of medical devices 1st Edition by JeanPierre Boutrand ISBN 0857090706 978-0857090706

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Product details: 

ISBN 10: 0857090706

ISBN 13:  978-0857090706

Author:  Jean-Pierre Boutrand

Table of contents: 

Part I: Introduction to Biocompatibility in Medical Devices

1. Concepts in Biocompatibility: New Biomaterials, New Paradigms and New Testing Regimes
    1.1 Introduction: Traditional biomaterials and biocompatibility test procedures
    1.2 The evolution from implantable medical devices to regenerative medicine and bionanotechnology
    1.3 New concepts and definitions for biocompatibility
    1.4 A proposed conceptual framework for new biocompatibility concepts and testing regimes
    1.5 Conclusions and future trends

2. Challenges in Biocompatibility and Failure of Biomaterials
    2.1 Introduction
    2.2 Concept of biocompatibility
    2.3 Examples of device recalls or alerts in the last decade related to biocompatibility issues
    2.4 Challenges in biocompatibility evaluation
    2.5 Conclusion

3. Biological Safety Evaluation Planning of Biomaterials
    3.1 Introduction
    3.2 Fundamentals of safety evaluation planning
    3.3 Safety evaluation planning for biomaterials
    3.4 Developing and documenting plans
    3.5 Using safety evaluations
    3.6 Conclusion

4. Biomechanical and Biochemical Compatibility in Innovative Biomaterials
    4.1 Introduction
    4.2 Selection of biomaterials
    4.3 Three generations of biomedical materials
    4.4 State-of-the-art development
    4.5 Future trends
    4.6 Conclusion

Part II: Evaluation and Characterisation of Biocompatibility in Medical Devices

5. Material and Chemical Characterization for the Biological Evaluation of Medical Device Biocompatibility
    5.1 Introduction
    5.2 Background
    5.3 Requirements of ISO 10993
    5.4 Characterization of materials
    5.5 Chemical characterization of extracts
    5.6 Using chemical and material characterization to demonstrate equivalency
    5.7 Acceptance criteria for equivalency
    5.8 Risk assessment of extracts
    5.9 Conclusion and future trends

6. Allowable Limits for Toxic Leachables: Practical Use of ISO 10993-17 Standard
    6.1 Introduction
    6.2 Process for setting tolerable intake (TI) values for compounds released from medical device materials
    6.3 Derivation of non-cancer TI values
    6.4 Derivation of cancer-based TI values
    6.5 Derivation of TI values for local effects
    6.6 Other considerations
    6.7 Conclusion

7. In Vivo and In Vitro Testing for the Biological Safety Evaluation of Biomaterials and Medical Devices
    7.1 Introduction
    7.2 Pre-testing considerations
    7.3 Sample preparation
    7.4 In vitro testing
    7.5 In vivo testing
    7.6 Conclusion

8. Practical Approach to Blood Compatibility Assessments: General Considerations and Standards
    8.1 Introduction
    8.2 Background: Blood composition
    8.3 Critical distinguishing factors of blood-contacting medical devices
    8.4 Responses in fluid blood in contact with devices
    8.5 Responses on material surfaces in contact with blood
    8.6 Assessing hemocompatibility according to international standards
    8.8 Sources of further information and advice

9. Medical Device Biocompatibility Evaluation: An Industry Perspective
    9.1 Introduction
    9.2 Developing a biological evaluation plan
    9.3 Implementing a biological evaluation plan
    9.4 Biological safety testing
    9.5 Creating a biological evaluation report
    9.6 Conclusion and future trends
    9.7 Sources of further information and advice
    9.9 Appendix: Example of a material component biological evaluation report template

10. Case Study: Overcoming Negative Test Results During Manufacture
     10.1 Introduction
     10.2 Cardio Medical: A fictitious case study
     10.3 The biological safety program
     10.4 Extractables and leachables
     10.5 Controlling risk at the manufacturing level
     10.6 Sterilization residuals
     10.7 Conclusion

11. Methods for the Characterisation and Evaluation of Drug–Device Combination Products
     11.1 Introduction to combination products
     11.2 Combination product regulation
     11.3 Demonstrating safety and efficacy
     11.4 Pre-clinical testing
     11.5 Manufacturing considerations
     11.6 Clinical studies
     11.7 Conclusion and future trends

Part III: Testing and Interpreting the Performance of Medical Devices

12. Methods and Interpretation of Performance Studies for Bone Implants
     12.1 Introduction
     12.2 Definitions
     12.3 Scope
     12.4 Principles for in vivo model selection
     12.5 Study design for bone implant performance
     12.6 Reference products and controls
     12.7 Osteoinductive and osteogenic performance
     12.8 In vitro limitations
     12.9 Fracture repair models
     12.10 Spinal fusion models
     12.11 Cylindrical defect models
     12.12 Segmental defect models
     12.13 Antimicrobial performance of implants
     12.14 Bioabsorbable and biodegradable materials
     12.15 Bone debris interactions
     12.16 Conclusion

13. Methods and Interpretation of Performance Studies for Dental Implants
     13.1 Introduction and definitions
     13.2 Importance of performance evaluation studies
     13.3 Experimental design
     13.4 Choice of model
     13.5 Statistical power calculation and analysis
     13.6 Analysis
     13.7 Translation from animal studies to human trials
     13.8 Acknowledgments

14. Non-Clinical Functional Evaluation of Medical Devices: General Recommendations and Examples for Soft Tissue Implants
     14.1 Introduction and definitions
     14.2 Purpose of functional studies
     14.3 Standards and documentation
     14.4 Designing a functional study
     14.5 Combining functional studies with safety standards
     14.6 Conclusion

15. Mechanical Testing for Soft and Hard Tissue Implants
     15.1 Introduction
     15.2 Principles of mechanical testing
     15.3 Implant-specific performance testing
     15.4 Advanced therapy products – cartilage
     15.5 Conclusion and future trends
     15.6 Sources of further information and advice

Part IV: International Regulation of Medical Devices

16. Biological Evaluation and Regulation of Medical Devices in the European Union
     16.1 Introduction
     16.2 Regulatory and legislative framework
     16.3 Essential requirements
     16.4 Presumption of conformity
     16.5 Using EN ISO 10993 standards to meet requirements
     16.6 The notified body
     16.7 Common pitfalls in evaluations
     16.8 Managing positive results in assessments
     16.9 Presenting the evaluation in the technical file
     16.10 Conclusion
     16.11 Sources of further information and advice
     16.12 Appendix: Model content of the evaluation submission

17. Biological Evaluation and Regulation of Medical Devices in Japan
     17.1 Introduction
     17.2 Outline of biological safety testing in Japan
     17.3 Biological safety tests
     17.4 Relationship between ISO and ASTM standards
     17.5 Classification, examination, and certification in Japan
     17.6 Outline of medical device GLP
     17.7 Conclusion

18. Medical Device Regulations in China
     18.1 Introduction
     18.2 Interpretation of ISO 10993 and additional SFDA requirements
     18.3 Major professional bodies

Part V: Histopathology Principles for Biocompatibility and Performance Studies

19. Microscopic and Ultrastructural Pathology in Medical Devices
     19.1 Introduction
     19.2 Morphologic assessment in safety studies
     19.3 Assessment of device performance
     19.4 Processing and sectioning of specimens
     19.5 Staining recommendations
     19.6 Qualitative and quantitative pathology in evaluations
     19.7 Ultrastructural pathology
     19.8 Morphologic assessment of ocular devices
     19.9 Conclusion
     19.10 Acknowledgments

Index

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Tags: Jean Pierre Boutrand, Biocompatibility and performance, medical devices