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Plastics in Medical Devices - 1st Edition - ISBN: 9780815520276, 9780815520283

Plastics in Medical Devices

1st Edition

Properties, Requirements and Applications

Author: Vinny R. Sastri
eBook ISBN: 9780815520283
Hardcover ISBN: 9780815520276
eBook ISBN: 9780080951935
Imprint: William Andrew
Published Date: 30th March 2010
Page Count: 352
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Table of Contents

  1. Introduction
    2. FDA and ISO Regulations
    3. Materials Used in Medical Devices
    4. Requirements for Plastics Used in Medical Devices
    5. Properties of Plastics in Selected Applications and Medical Device Segments
    6. Polymer Additives Used to Enhance Material Properties for Medical Device Applications
    7. Commodity Thermoplastics
    8. Engineering Thermoplastics
    9. High Temperature Thermoplastics
    10. Thermosets
    11. Elastomers
    12. Biodegradable and Bioresorbable Plastics
    13. Transparent Plastics
    14. Comparison Tables
    15. Economics and Future Trends


No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.


Engineers, product designers, product developers, manufacturing personnel, regulators, and marketers in the medical plastics industry.


No. of pages:
© William Andrew 2010
30th March 2010
William Andrew
eBook ISBN:
Hardcover ISBN:
eBook ISBN:

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About the Author

Vinny R. Sastri

Vinny Sastri, Ph.D., is the President of Winovia, LLC, a consultancy company specializing in quality management systems, notably in the area of medical devices. Dr. Sastri’s areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CA/PA, and materials. He is a certified Six Sigma black-belt, and has a strong track record in leading, managing, establishing and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence. Dr. Sastri was on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training (along with the FDA) on the FDA Quality Systems Requirements and Industry Practice, Design Controls, Process Validation and Risk Management to the medical device industry. He now conducts public and in-house training through his company Winovia LLC. Prior to starting Winovia, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies including BASF, AlliedSignal and General Electric. He earned a Ph.D. from Rutgers University, completed post-doctoral work at Brooklyn Polytechnic Institute, and was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. Dr. Sastri has over 20 publications and 6 patents, and has presented at many international conferences and webinars in the United States, Europe, and Asia.

Affiliations and Expertise

President, Winovia, LLC, a consultancy company