Biocompatibility and performance of medical devices / edited by Jean-Pierre Boutrand.

Other author Boutrand, Jean-Pierre.
Format Electronic
Publication InfoOxford ; Philadelphia : Woodhead Publishing, 2012.
Descriptionxxiii, 518 pages, 12 unnumbered pages of plates : illustrations ; 24 cm
Supplemental ContentFull text available from eBook - Materials Science 2012 (Elsevier and Woodhead) [EBCMS12W]
Subjects
Biomedical materials.
Biomedical materials--Biocompatibility.
Biocompatible Materials.
Materials Testing.

SeriesWoodhead Publishing series in biomaterials, 2049-9485 ; Number 50
Woodhead Publishing series in biomaterials ; no. 50. 2049-9485 ^A1250575
Contents Machine generated contents note: pt. I Introduction to biocompatibility in medical devices -- 1.Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes / D. Williams -- 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 -- 1.6.References -- 2.Challenges in biocompatibility and failure of biomaterials / R. Eloy -- 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 -- 2.6.References -- 3.Biological safety evaluation planning of biomaterials / D. Parente -- 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 -- 3.7.Sources of further information and advice -- 4.Biomechanical and biochemical compatibility in innovative biomaterials / Z. X. Guo -- 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 -- 4.7.References -- pt. II Evaluation and characterisation of biocompatibility in medical devices -- 5.Material and chemical characterization for the biological evaluation of medical device biocompatibility / D. E. Albert -- 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 -- 5.10.References -- 6.Allowable limits for toxic leachables: practical use of ISO 10993-17 standard / R. P. Brown -- 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 -- 6.8.References -- 7.In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices / R. E. Geertsma -- 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 -- 7.7.References -- 8.Practical approach to blood compatibility assessments: general considerations and standards / J. M. Anderson -- 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 -- 8.7.Conclusion and future trends -- 8.8.Sources of further information and advice -- 8.9.References -- 9.Medical device biocompatibility evaluation: an industry perspective / X. Tang -- 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 -- 9.8.References -- 9.9.Appendix: example of a material component biological evaluation report template -- 10.Case study: overcoming negative tests results during manufacture / D. Parente -- 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 / A. L. Lewis -- 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 -- 11.8.References -- pt. III Testing and interpreting the performance of medical devices -- 12.Methods and interpretation of performance studies for bone implants / J.-P. Boutrand -- 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 -- 12.17.References -- 13.Methods and interpretation of performance studies for dental implants / M. Dard -- 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 -- 13.9.Sources of further information and advice -- 13.10.References -- 14.Non-clinical functional evaluation of medical devices: general recommendations and examples for soft tissue implants / G. Clermont -- 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 -- 14.7.References -- 15.Mechanical testing for soft and hard tissue implants / C. Kaddick -- 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 -- 15.7.References -- pt. IV International regulation of medical devices -- 16.Biological evaluation and regulation of medical devices in the European Union / A.T. Keene -- 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 -- 17.Biological evaluation and regulation of medical devices in Japan / K. Kojima -- 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 -- 17.8.References -- 18.Medical device regulations in China / S. Likui -- 18.1.Introduction -- 18.2.Interpretation of ISO 10993 and additional State Food and Drug Administration (SFDA) requirements -- 18.3.Major professional bodies -- 18.4.References -- pt. V Histopathology principles for biocompatibility and performance studies -- 19.Microscopic and ultrastructural pathology in medical devices / J. Render -- 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 -- 19.11.References.
Bibliography noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2012947092
ISBN9780857090706 (print)
ISBN0857090704 (print)

Availability

Library Location Call Number Status Item Actions
Electronic Resources Access Content Online ✔ Available