Biocompatibility and Performance of Medical Devices

Herausgegeben:Boutrand, Jean-Pierre

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Woodhead Publishing Series in Biomaterials
• Verlag: Elsevier Science & Technology / Woodhead Publishing
• Artikelnr. des Verlages: C2013-0-16134-X
• Seitenzahl: 544
• Englisch
• Abmessung: 233mm x 155mm x 240mm
• Gewicht: 1095g
• ISBN-13: 9780857090706
• Artikelnr.: 35894925

Autorenporträt

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).

Inhaltsangabe

Contributor contact details

Woodhead Publishing Series in Biomaterials

Foreword

Introduction

Dedication

Part I: Introduction to biocompatibility in medical devices

Chapter 1: Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes

Abstract:

1.1 Introduction: traditional biomaterials and biocompatibility test procedures

1.2 The evolution from implantable medical devices to regenerative medicine and bionanotechnology

1.3 New concepts and definitions for biocompatibility

1.4 A proposed conceptual framework for new biocompatibility concepts and testing regimes

1.5 Conclusions and future trends

Chapter 2: Challenges in biocompatibility and failure of biomaterials

Abstract:

2.1 Introduction

2.2 Concept of biocompatibility

2.3 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered

2.4 Challenges in biocompatibility evaluation

2.5 Conclusion

Chapter 3: Biological safety evaluation planning of biomaterials

Abstract:

3.1 Introduction

3.2 The fundamentals of safety evaluation planning

3.3 Safety evaluation planning for biomaterials

3.4 Developing and documenting plans

3.5 Using safety evaluations

3.6 Conclusion

Chapter 4: Biomechanical and biochemical compatibility in innovative biomaterials

Abstract:

4.1 Introduction

4.2 Selection of biomaterials

4.3 Three generations of biomedical materials

4.4 State-of-the-art development

4.5 Future trends

4.6 Conclusion

Part II: Evaluation and characterisation of biocompatibility in medical devices

Chapter 5: Material and chemical characterization for the biological evaluation of medical device biocompatibility

Abstract:

5.1 Introduction

5.2 Background

5.3 Requirements of ISO 10993

5.4 Characterization of materials

5.5 Chemical characterization of extracts

5.6 Using chemical and material characterization to demonstrate equivalency

5.7 Acceptance criteria for equivalency

5.8 Risk assessment of extracts

5.9 Conclusion and future trends

Chapter 6: Allowable limits for toxic leachables: practical use of ISO 10993-17 standard

Abstract:

6.1 Introduction

6.2 Process for setting tolerable intake (TI) values for compounds released from medical device materials

6.3 Derivation of non-cancer TI values

6.4 Derivation of cancer-based TI values

6.5 Derivation of TI values for local effects

6.6 Other issues to consider

6.7 Conclusion

Chapter 7: In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices

Abstract:

7.1 Introduction

7.2 Pre-testing considerations

7.3 Sample preparation

7.4 In vitro testing

7.5 In vivo testing

7.6 Conclusion

Chapter 8: Practical approach to blood compatibility assessments: general considerations and standards

Abstract:

8.1 Introduction

8.2 Background: blood composition

8.3 Critical distinguishing factors presented by blood-contacting medical devices

8.4 Responses in fluid blood in contact with medical devices

8.5 Responses by materials, or upon their surfaces, in contact with blood

8.6 Assessing hemocompatibility according to international standards

8.8 Sources of further information and advice

Chapter 9: Medical device biocompatibility evaluation: an industry perspective

Abstract:

9.1 Introduction

9.2 Developing a biological evaluation plan

9.3 Implementing a biological evaluation plan

9.4 Biological safety testing

9.5 Creating a biological evaluation report

9.6 Conclusion and future trends

9.7 S

Rezensionen

"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)