Biocompatibility and Performance of Medical Devices (Woodhead Publishing Series in Biomaterials) - Softcover

Softcover

ISBN 10: 0081026439 ISBN 13: 9780081026434

Publisher: Woodhead Publishing, 2019

Synopsis

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies.

• Presents diverse insights from experts in government, industry and academia
• Delivers a comprehensive overview of testing and interpreting medical device performance
• Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

About this title

About the Author

Jean-Pierre (JP) Boutrand, DVM, MS is a Senior Vice President at Eurofins, Luxembourg.

Dr. Boutrand is an executive leader, veterinarian, and recognized authority in nonclinical evaluation, biological safety, and testing strategies for medical devices and combination products. With over 25 years of global leadership―including senior executive roles at NAMSA (Vice President of Global Laboratory Services), Labcorp, Charles River Laboratories and Eurofins―Dr. Boutrand has guided the safety, compliance, and commercialization pathways for hundreds of complex medical devices worldwide. A former registered expert on the biological safety of medical devices for regulatory agencies including ANSM, Dr. Boutrand specialized in integrated risk management, ISO 10993 compliance, toxicology assessment strategies, and pharmacology models. He is the editor and author of the textbook Biocompatibility and Performance of Medical Devices (Woodhead Publishing / Elsevier), currently in its 3rd edition, and has authored over 120 scientific publications and global conference presentations on biomaterial safety, histopathology, and regulatory evaluation frameworks.

From the Back Cover

Biocompatibility and Performance of Medical Devices, Second Edition, brings an understanding of biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. This new edition is updated and expanded to include the very latest developments in biocompatibility and performance testing.

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 characterization 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

Edition details

• Publisher: Woodhead Publishing
• Publication date: 2019
• Language: English
• ISBN 10: 0081026439
• ISBN 13: 9780081026434
• Binding: Paperback
• Edition number: 2
• Number of pages: 586
• Editor: Boutrand Jean-Pierre