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 Boutrand is General Manager and Scientific Director for the European division of NAMSA (the world leading medical device evaluation company). Dr Boutrand has been involved in more than 100 public presentations and publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for ANSM (the French agency for the safety of health products).

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