Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered in detail and supported by data tables.

The synthesis and production of each polymer or family of polymers are described in some detail, as these methods have an important effect on critical properties such as sterilization and biocompatibility.

In this new edition Dr. Sastri not only provides a thorough update of the first edition chapters to reflect the latest developments in plastic materials, applications and new requirements, but also includes more detailed discussions of market and regulatoriy aspects and supplier controls. A new chapter on process validation has also been added.

Key Features

  • Comprehensive coverage of uses of polymers for medical devices.
  • Unique coverage of medical device regulatory aspects, supplier control and process validation.
  • Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices.

Table of Contents



About the Author

1. Introduction

1.1 Introduction

1.2 Medical Device Definition

1.3 Types of Devices

1.4 Materials Used in Medical Devices

1.5 Medical Devices—Material Selection Process

1.6 Organization of This Book


2. Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview

2.1 History and Introduction

2.2 United States Regulations

2.3 ISO 13485 (European and Global Standard)

2.4 Other Countries

2.5 Global Harmonization Task Force (GHTF)

2.6 Applicability of the Regulations to Material Suppliers

2.7 Conclusion


3. Materials Used in Medical Devices

3.1 Introduction

3.2 Metals

3.3 Ceramics and Glass

3.4 Plastics

3.5 Why Plastics?

3.6 Types of Plastics

3.7 Homopolymers and Copolymers

3.8 Polymer Blends and Alloys

3.9 Conclusion


4. Material Requirements for Plastics Used in Medical Devices

4.1 Introduction

4.2 Material Characterization

4.3 Sterilization

4.4 Chemical Resistance

4.5 Biocompatibility

4.6 USP Class VI

4.7 ISO 10993

4.8 Shelf Life and Aging

4.9 Joining and Welding

4.10 Conclusion


5. Polymer Additives Used to Enhance Material Properties for Medical Device Applications

5.1 Introduction

5.2 Types of Additives

5.3 Things to Consider When Using Additives

5.4 Plasticizers

5.5 Wear-Resistant and Lubricious Additives

5.6 Pigments

5.7 Laser Marking

5.8 Radiopaque Additives

5.9 Antimicrobials

5.10 Conductive Fillers

5.11 Nanoadditives

5.12 Stabilizers

5.13 Conclusion


6. Commodity Thermoplastics: P


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© 2014
William Andrew
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