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. Examines the key concepts and challenges faced in relation to biocompatibility in medical devicesDiscusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessmentDelivers a comprehensive overview of testing and interpreting medical device performance INDICE: Contributor contact details Woodhead Publishing Series in Biomaterials Foreword Introduction Dedication Part I: Introduction to biocompatibility in medical devices Chapter 1: Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes Abstract: 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 Chapter 2: Challenges in biocompatibility and failure of biomaterials Abstract: 2.1 Introduction 2.2 Concept of biocompatibility 2.3 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered 2.4 Challenges in biocompatibility evaluation 2.5 Conclusion Chapter 3: Biological safety evaluation planning of biomaterials Abstract: 3.1 Introduction 3.2 The 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 Chapter 4: Biomechanical and biochemical compatibility in innovative biomaterials Abstract: 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 Chapter 5: Material and chemical characterization for the biological evaluation of medical device biocompatibility Abstract: 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 Chapter 6: Allowable limits for toxic leachables: practical use of ISO 10993-17 standard Abstract: 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 issues to consider 6.7 Conclusion Chapter 7: In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices Abstract: 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 Chapter 8: Practical approach to blood compatibility assessments: general considerations and standards Abstract: 8.1 Introduction 8.2 Background: blood composition 8.3 Critical distinguishing factors presented by blood-contacting medical devices 8.4 Responses in fluid blood in contact with medical devices 8.5 Responses by materials, or upon their surfaces, in contact with blood 8.6 Assessing hemocompatibility according to international standards 8.8 Sources of further information and advice Chapter 9: Medical device biocompatibility evaluation: an industry perspective Abstract: 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 1.0 Introduction 2.0 Chemical characterization 3.0 Manufacturing processing 4.0 Tissue contact 5.0 Evaluation of ISO 10993-1 compliance 6.0 Discussion 7.0 Conclusions Chapter 10: Case study: overcoming negative test results during manufacture Abstract: 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 Chapter 11: Methods for the characterisation and evaluation of drug-device combination products Abstract: 11.1 Introduction to combination products 11.2 Combination product regulation 11.3 Demonstrating safety and efficacy of combination products 11.4 Pre-clinical testing of combination products 11.5 Aspects to consider in the manufacture of combination products 11.6 Clinical studies for combination products 11.7 Conclusion and future trends Part III: Testing and interpreting the performance of medical devices Chapter 12: Methods and interpretation of performance studies for bone implants Abstract: 12.1 Introduction 12.2 Definitions 12.3 Scope 12.4 Principles for the selection of an in vivo model to evaluate performance of bone implants 12.5 Designing a study to evaluate performance of bone implants 12.6 Selection of reference products and controls 12.7 Osteoinductive and osteogenic performances 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 performances of implants 12.14 Bioabsorbable and biodegradable materials 12.15 Bone debris interaction with implant performance 12.16 Conclusion Chapter 13: Methods and interpretation of performance studies for dental implants Abstract: 13.1 Introduction and definitions 13.2 Importance of performance evaluation studies for dental implants 13.3 Experimental design of a performance trial for dental implants 13.4 Choice of model 13.5 Statistical power calculation and analysis 13.6 Analysis 13.7 Translation from animal studies to human clinical trials 13.8 Acknowledgments Chapter 14: Non-clinical functional evaluation of medical devices: general recommendations and examples for soft tissue implants Abstract: 14.1 Introduction and definitions 14.2 The purpose of functional studies 14.3 Standards and documentation 14.4 How to design a functional study 14.5 Combining non-clinical functional studies with requirements of safety standards 14.6 Conclusion Chapter 15: Mechanical testing for soft and hard tissue implants Abstract: 15.1 Introduction 15.2 Principles of setting up a mechanical test 15.3 Implant-specific mechanical performance testing 15.4 Advanced therapy products (ATPs) - cartilage 15.5 Conclusion and future trends 15.6 Sources of further information and advice Part IV: International regulation of medical devices Chapter 16: Biological evaluation and regulation of medical devices in the European Union Abstract: 16.1 Introduction 16.2 The regulatory and legislative framework 16.3 Essential requirements 16.4 Presumption of conformity 16.5 Using the EN ISO 10993 series of standards to meet the essential requirements 16.6 The notified body 16.7 Common pitfalls in biological evaluations 16.8 Managing positive results in the biological safety assessment 16.9 Presenting the biological evaluation within the technical file 16.10 Conclusion 16.11 Sources of further information and advice 16.12 Appendix: model content of the biological evaluation submission Chapter 17: Biological evaluation and regulation of medical devices in Japan Abstract: 17.1 Introduction 17.2 Outline of biological safety testing in Japan 17.3 Biological safety tests 17.4 Relationship and comparison between the International Organization for Standardization (ISO) standard and American Society for Testing and Materials (ASTM) standard 17.5 Relationship between classification, examination, and certification in Japan 17.6 Outline of the medical device Good Laboratory Practice (GLP) 17.7 Conclusion Chapter 18: Medical device regulations in China Abstract: 18.1 Introduction 18.2 Interpretation of ISO 10993 and additional State Food and Drug Administration (SFDA) requirements 18.3 Major professional bodies Part V: Histopathology principles for biocompatibility and performance studies Chapter 19: Microscopic and ultrastructural pathology in medical devices Abstract: 19.1 Introduction 19.2 Morphologic assessment in the safety studies of biomaterials and medical devices 19.3 Assessment of the performance of biomaterials and medical devices 19.4 Processing and sectioning of specimens 19.5 Staining recommendations 19.6 Qualitative and quantitative pathology used in the evaluation of biomaterials and medical devices 19.7 Ultrastructural pathology 19.8 Morphologic assessment of ocular medical devices 19.9 Conclusion 19.10 Acknowledgments Index
- ISBN: 978-0-08-101570-4
- Editorial: Woodhead Publishing
- Encuadernacion: Rústica
- Páginas: 540
- Fecha Publicación: 30/06/2016
- Nº Volúmenes: 1
- Idioma: Inglés