Biocompatibility and Performance of Medical Devices

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.

• 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...

  Autorentext

  J-P Boutrand, Biomatech, France

  Klappentext

  This book will describe and explain the factors that influence the biocompatibility of materials and medical devices, the methods to predict or screen biocompatibility, how to build a biological safety evaluation plan for medical devices, strategies and tactics in biocompatibility and biological performance evaluation of medical devices.

  Zusammenfassung
  This book describes and explains the factors that influence the biocompatibility of materials and medical devices.

  Inhalt

  Biocompatibility of current materials; The concept of biocompatibility; New materials for the future; A process for the evaluation and selection of biomaterials; Biological safety evaluation planning; Physio-chemical characterization of medical devices: Principles and uses; Allowing limits for toxic leachables; Common biocompatibility tests and when to use them; Making the best use of hemocompatibility tests; Biocompatibility and performances of medical devices from the notified body standpoint; Medical device regulations in China; Case study: Overcoming adverse tests results during manufacture; Methods and interpretation of performance studies for soft tissues implants; Methods and interpretation of performance studies for bone implants; Methods and interpretation of performance studies for dental implants; Mechanical testing for soft and hard tissues implants: An overview; Understanding the microscopic and ultrastructural assessment of implantable medical devices.