Jean-Pierre Boutrand
Elsevier Science
e druk, 2012
9780857090706
Biocompatibility and Performance of Medical Devices
Specificaties
Gebonden, blz.
|
Engels
Elsevier Science |
e druk, 2012
ISBN13: 9780857090706
Rubricering
Onderdeel van serie
Woodhead Publishing Series in Biomaterials
Verwachte levertijd ongeveer 9 werkdagen
Samenvatting
Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices.Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies.With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics.
Specificaties
Inhoudsopgave
<p>Contributor contact details</p> <p>Woodhead Publishing Series in Biomaterials</p> <p>Foreword</p> <p>Introduction</p> <p>Dedication</p> <p>Part I: Introduction to biocompatibility in medical devices</p> <p>Chapter 1: Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes</p> <p>Abstract:</p> <p>1.1 Introduction: traditional biomaterials and biocompatibility test procedures</p> <p>1.2 The evolution from implantable medical devices to regenerative medicine and bionanotechnology</p> <p>1.3 New concepts and definitions for biocompatibility</p> <p>1.4 A proposed conceptual framework for new biocompatibility concepts and testing regimes</p> <p>1.5 Conclusions and future trends</p> <p>Chapter 2: Challenges in biocompatibility and failure of biomaterials</p> <p>Abstract:</p> <p>2.1 Introduction</p> <p>2.2 Concept of biocompatibility</p> <p>2.3 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered</p> <p>2.4 Challenges in biocompatibility evaluation</p> <p>2.5 Conclusion</p> <p>Chapter 3: Biological safety evaluation planning of biomaterials</p> <p>Abstract:</p> <p>3.1 Introduction</p> <p>3.2 The fundamentals of safety evaluation planning</p> <p>3.3 Safety evaluation planning for biomaterials</p> <p>3.4 Developing and documenting plans</p> <p>3.5 Using safety evaluations</p> <p>3.6 Conclusion</p> <p>Chapter 4: Biomechanical and biochemical compatibility in innovative biomaterials</p> <p>Abstract:</p> <p>4.1 Introduction</p> <p>4.2 Selection of biomaterials</p> <p>4.3 Three generations of biomedical materials</p> <p>4.4 State-of-the-art development</p> <p>4.5 Future trends</p> <p>4.6 Conclusion</p> <p>Part II: Evaluation and characterisation of biocompatibility in medical devices</p> <p>Chapter 5: Material and chemical characterization for the biological evaluation of medical device biocompatibility</p> <p>Abstract:</p> <p>5.1 Introduction</p> <p>5.2 Background</p> <p>5.3 Requirements of ISO 10993</p> <p>5.4 Characterization of materials</p> <p>5.5 Chemical characterization of extracts</p> <p>5.6 Using chemical and material characterization to demonstrate equivalency</p> <p>5.7 Acceptance criteria for equivalency</p> <p>5.8 Risk assessment of extracts</p> <p>5.9 Conclusion and future trends</p> <p>Chapter 6: Allowable limits for toxic leachables: practical use of ISO 10993-17 standard</p> <p>Abstract:</p> <p>6.1 Introduction</p> <p>6.2 Process for setting tolerable intake (TI) values for compounds released from medical device materials</p> <p>6.3 Derivation of non-cancer TI values</p> <p>6.4 Derivation of cancer-based TI values</p> <p>6.5 Derivation of TI values for local effects</p> <p>6.6 Other issues to consider</p> <p>6.7 Conclusion</p> <p>Chapter 7: In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices</p> <p>Abstract:</p> <p>7.1 Introduction</p> <p>7.2 Pre-testing considerations</p> <p>7.3 Sample preparation</p> <p>7.4 In vitro testing</p> <p>7.5 In vivo testing</p> <p>7.6 Conclusion</p> <p>Chapter 8: Practical approach to blood compatibility assessments: general considerations and standards</p> <p>Abstract:</p> <p>8.1 Introduction</p> <p>8.2 Background: blood composition</p> <p>8.3 Critical distinguishing factors presented by blood-contacting medical devices</p> <p>8.4 Responses in fluid blood in contact with medical devices</p> <p>8.5 Responses by materials, or upon their surfaces, in contact with blood</p> <p>8.6 Assessing hemocompatibility according to international standards</p> <p>8.8 Sources of further information and advice</p> <p>Chapter 9: Medical device biocompatibility evaluation: an industry perspective</p> <p>Abstract:</p> <p>9.1 Introduction</p> <p>9.2 Developing a biological evaluation plan</p> <p>9.3 Implementing a biological evaluation plan</p> <p>9.4 Biological safety testing</p> <p>9.5 Creating a biological evaluation report</p> <p>9.6 Conclusion and future trends</p> <p>9.7 Sources of further information and advice</p> <p>9.9 Appendix: example of a material component biological evaluation report template</p> <p>1.0 Introduction</p> <p>2.0 Chemical characterization</p> <p>3.0 Manufacturing processing</p> <p>4.0 Tissue contact</p> <p>5.0 Evaluation of ISO 10993-1 compliance</p> <p>6.0 Discussion</p> <p>7.0 Conclusions</p> <p>Chapter 10: Case study: overcoming negative test results during manufacture</p> <p>Abstract:</p> <p>10.1 Introduction</p> <p>10.2 Cardio Medical: a fictitious case study</p> <p>10.3.The biological safety program</p> <p>10.4.Extractables and leachables</p> <p>10.5 Controlling risk at the manufacturing level</p> <p>10.6 Sterilization residuals</p> <p>10.7 Conclusion</p> <p>Chapter 11: Methods for the characterisation and evaluation of drug-device combination products</p> <p>Abstract:</p> <p>11.1 Introduction to combination products</p> <p>11.2 Combination product regulation</p> <p>11.3 Demonstrating safety and efficacy of combination products</p> <p>11.4 Pre-clinical testing of combination products</p> <p>11.5 Aspects to consider in the manufacture of combination products</p> <p>11.6 Clinical studies for combination products</p> <p>11.7 Conclusion and future trends</p> <p>Part III: Testing and interpreting the performance of medical devices</p> <p>Chapter 12: Methods and interpretation of performance studies for bone implants</p> <p>Abstract:</p> <p>12.1 Introduction</p> <p>12.2 Definitions</p> <p>12.3 Scope</p> <p>12.4 Principles for the selection of an in vivo model to evaluate performance of bone implants</p> <p>12.5 Designing a study to evaluate performance of bone implants</p> <p>12.6 Selection of reference products and controls</p> <p>12.7 Osteoinductive and osteogenic performances</p> <p>12.8 In vitro limitations</p> <p>12.9 Fracture repair models</p> <p>12.10 Spinal fusion models</p> <p>12.11 Cylindrical defect models</p> <p>12.12 Segmental defect models</p> <p>12.13 Antimicrobial performances of implants</p> <p>12.14 Bioabsorbable and biodegradable materials</p> <p>12.15 Bone debris interaction with implant performance</p> <p>12.16 Conclusion</p> <p>Chapter 13: Methods and interpretation of performance studies for dental implants</p> <p>Abstract:</p> <p>13.1 Introduction and definitions</p> <p>13.2 Importance of performance evaluation studies for dental implants</p> <p>13.3 Experimental design of a performance trial for dental implants</p> <p>13.4 Choice of model</p> <p>13.5 Statistical power calculation and analysis</p> <p>13.6 Analysis</p> <p>13.7 Translation from animal studies to human clinical trials</p> <p>13.8 Acknowledgments</p> <p>Chapter 14: Non-clinical functional evaluation of medical devices: general recommendations and examples for soft tissue implants</p> <p>Abstract:</p> <p>14.1 Introduction and definitions</p> <p>14.2 The purpose of functional studies</p> <p>14.3 Standards and documentation</p> <p>14.4 How to design a functional study</p> <p>14.5 Combining non-clinical functional studies with requirements of safety standards</p> <p>14.6 Conclusion</p> <p>Chapter 15: Mechanical testing for soft and hard tissue implants</p> <p>Abstract:</p> <p>15.1 Introduction</p> <p>15.2 Principles of setting up a mechanical test</p> <p>15.3 Implant-specific mechanical performance testing</p> <p>15.4 Advanced therapy products (ATPs) – cartilage</p> <p>15.5 Conclusion and future trends</p> <p>15.6 Sources of further information and advice</p> <p>Part IV: International regulation of medical devices</p> <p>Chapter 16: Biological evaluation and regulation of medical devices in the European Union</p> <p>Abstract:</p> <p>16.1 Introduction</p> <p>16.2 The regulatory and legislative framework</p> <p>16.3 Essential requirements</p> <p>16.4 Presumption of conformity</p> <p>16.5 Using the EN ISO 10993 series of standards to meet the essential requirements</p> <p>16.6 The notified body</p> <p>16.7 Common pitfalls in biological evaluations</p> <p>16.8 Managing positive results in the biological safety assessment</p> <p>16.9 Presenting the biological evaluation within the technical file</p> <p>16.10 Conclusion</p> <p>16.11 Sources of further information and advice</p> <p>16.12 Appendix: model content of the biological evaluation submission</p> <p>Chapter 17: Biological evaluation and regulation of medical devices in Japan</p> <p>Abstract:</p> <p>17.1 Introduction</p> <p>17.2 Outline of biological safety testing in Japan</p> <p>17.3 Biological safety tests</p> <p>17.4 Relationship and comparison between the International Organization for Standardization (ISO) standard and American Society for Testing and Materials (ASTM) standard</p> <p>17.5 Relationship between classification, examination, and certification in Japan</p> <p>17.6 Outline of the medical device Good Laboratory Practice (GLP)</p> <p>17.7 Conclusion</p> <p>Chapter 18: Medical device regulations in China</p> <p>Abstract:</p> <p>18.1 Introduction</p> <p>18.2 Interpretation of ISO 10993 and additional State Food and Drug Administration (SFDA) requirements</p> <p>18.3 Major professional bodies</p> <p>Part V: Histopathology principles for biocompatibility and performance studies</p> <p>Chapter 19: Microscopic and ultrastructural pathology in medical devices</p> <p>Abstract:</p> <p>19.1 Introduction</p> <p>19.2 Morphologic assessment in the safety studies of biomaterials and medical devices</p> <p>19.3 Assessment of the performance of biomaterials and medical devices</p> <p>19.4 Processing and sectioning of specimens</p> <p>19.5 Staining recommendations</p> <p>19.6 Qualitative and quantitative pathology used in the evaluation of biomaterials and medical devices</p> <p>19.7 Ultrastructural pathology</p> <p>19.8 Morphologic assessment of ocular medical devices</p> <p>19.9 Conclusion</p> <p>19.10 Acknowledgments</p> <p>Index</p>