- 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
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.
Biocompatibility and Performance of Medical Devices, 1st Edition
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.
Quotes and reviews
Multiple authors … have come together to present their views on the best options, the best techniques and the optimal methods of interpretation of data. Expertly assembled by Jean-Pierre Boutrand … the contents of this book will allow the reader to attain an insight into the complexities of this testing arena., Professor David Williams, Wake Forest Baptist Medical Center, USA (from the Foreword)