Description

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.

Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.

With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area.

Key Features

  • Reviews established and commonly used technologies alongside new and emerging processes
  • Introduces and reviews the key concepts and challenges involved in sterilisation
  • Discusses future trends in the sterilisation of biomaterials and medical devices

Readership

Materials scientists; Engineers and researchers within the medical devices industry; academics and clinicians

Table of Contents

Contributor contact details

Woodhead Publishing Series in Biomaterials

Chapter 1: Introduction to sterilization: definitions and challenges

Abstract:

1.1 Introduction

1.2 Definitions of sterilization in the context of biomaterials

1.3 Validation, monitoring and safety of sterilization methods

1.4 Challenges and constraints of sterilization methods

1.5 Ideal versus actual sterilization methods

1.6 Conclusions

Chapter 2: Steam and dry heat sterilization of biomaterials and medical devices

Abstract:

2.1 Introduction

2.2 Steam sterilization

2.3 Different methods of steam sterilization

2.4 Test methods for the effectiveness of steam sterilization

2.5 Dry heat sterilization

2.6 Testing and validating dry heat sterilization

2.7 Conclusions

Chapter 3: Sterilisation of healthcare products by ionising radiation: principles and standards

Abstract:

3.1 Introduction

3.2 Interaction of ionising radiation with matter

3.3 Sources of ionising radiation

3.4 Validation and international standards of sterilisation by ionising radiation

3.5 Conclusions and future trends

3.6 Sources of further information and advice

Chapter 4: Ethylene oxide (EO) sterilization of healthcare products

Abstract:

4.1 Introduction

4.2 Advantages of ethylene oxide (EO) sterilization

4.3 Disadvantages of ethylene oxide (EO) sterilization

4.4 Sterilization process characterization

4.5 Process definition

4.6 Process optimization and the process challenge device

4.7 Qualification of ethylene oxide (EO) sterilization

4.8 Contract sterilization

4.9 Acknowledgments

Chapter 5: Non-traditional sterilization techniques for biomaterials and medical devices

Abstract:

5.1 Introduction

5.2 Non-tra

Details

No. of pages:
352
Language:
English
Copyright:
© 2012
Published:
Imprint:
Woodhead Publishing
Print ISBN:
9781845699321
Electronic ISBN:
9780857096265

About the editors

Sophie Lerouge

Sophie Lerouge is Professor of Mechanical Engineering at the École de technologie supérieure, Adjunct Professor in the Department of Radiology at the University of Montreal, and researcher at the University of Montreal Hospital Research Center (CRCHUM), Montreal, Canada.

Anne Simmons

Anne Simmons is Professor of Mechanical and Manufacturing Engineering at the University of New South Wales, Australia.