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Biocompatibility and Performance of Medical Devices (Woodhead Publishing Series in Biomaterials) - Hardcover
Book 51 of 343: Woodhead Publishing Series in Biomaterials
Synopsis
Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe, biocompatible, and perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces key concepts and challenges faced in relation to biocompatibility in medical devices. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices, including material and chemical characterization, 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 preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing for soft and hard tissues implants discussed. Part four provides information on the international regulation of medical devices in the European Union, Japan and China, before concluding in part five with a review of histopathology principles for biocompatibility and performance studies.
Key Features: examines the key concepts and challenges faced in relation to biocompatibility in medical devices; discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment; delivers a comprehensive overview of testing and interpreting medical device performance.
Contents: Part 1 Introduction to biocompatibility in medical devices: Concepts in biocompatibility: New biomaterials, new paradigms and new testing regimes; Challenges in biocompatibility and failure of biomaterials; Biological safety evaluation planning of biomaterials; Biomechanical and biochemical compatibility in innovative biomaterials. Part 2 Evaluation and characterisation of biocompatibility in medical devices: Material and chemical characterization for the biological evaluation of medical device biocompatibility; Allowable limits for toxic leachables: Practical Use of ISO Standard; In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices; Practical approach to blood compatibility assessments: General considerations and standards; Medical device biocompatibility evaluation: An industry perspective; Case study: Overcoming negative tests results during manufacture; Methods for the characterisation and evaluation of drug-device combination products. Part 3 Testing and interpreting the performance of medical devices: Methods and interpretation of performance studies for bone implants; Methods and interpretation of performance studies for dental implants; Non-clinical functional evaluation of medical devices: General recommendations and examples for soft tissue implants; Mechanical testing for soft and hard tissues implants. Part 4 International regulation of medical devices: Biological evaluation and regulation of medical devices in the European Union; Biological evaluation and regulation of medical devices in Japan; Medical device regulations in China. Part 5 Histopathology principles for biocompatibility and performance studies: Microscopic and ultrastructural pathology in medical devices.
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About the Author
Jean-Pierre Boutrand is General Manager and Scientific Director for Biomatech, the European division of NAMSA. Dr. Boutrand has been involved in more than 60 public presentations or publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for the AFSSAPS.
"About this title" may belong to another edition of this title.
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Biocompatibility and Performance of Medical Devices
Published by
Elsevier Science & Technology, Woodhead Publishing, 2012
ISBN 10: 0857090704
ISBN 13: 9780857090706
New
Hardcover
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany
Seller rating 5 out of 5 stars
Buch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. Englisch. Seller Inventory # 9780857090706
Seller Image
Biocompatibility and Performance of Medical Devices
Published by
Elsevier Science & Technology, Woodhead Publishing, 2012
ISBN 10: 0857090704
ISBN 13: 9780857090706
New
Hardcover
Seller: AHA-BUCH GmbH, Einbeck, Germany
Seller rating 5 out of 5 stars
Buch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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. Seller Inventory # 9780857090706