Plastics in Medical Devices

2nd Edition

Properties, Requirements, and Applications

Authors: Vinny R. Sastri
Hardcover ISBN: 9781455732012
eBook ISBN: 9780323265638
Imprint: William Andrew
Published Date: 21st November 2013
Page Count: 336
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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


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 and backed up with a wealth of data tables.

Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else.

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.


Engineers, scientists, and managers involved in the design and manufacture of medical devices.

Engineers and scientists involved in the tech support for and development and marketing of materials for use in medical device manufacture.

Other professionals involved in the medical device industry, the clinical use of medical devices, and related regulatory and compliance issues.

The medical device supply chain, where Process Validation and Supplier Controls are a requirement.


No. of pages:
© William Andrew 2014
William Andrew
eBook ISBN:
Hardcover ISBN:

About the Authors

Vinny R. Sastri Author

Affiliations and Expertise

President, Winovia LLC