Plastics in Medical Devices

Plastics in Medical Devices

Properties, Requirements, and Applications

3rd Edition - November 24, 2021

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  • Author: Vinny R. Sastri
  • eBook ISBN: 9780323851275
  • Hardcover ISBN: 9780323851268

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Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book 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. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices.

Key Features

  • Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data
  • Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management
  • Supports the development, marketing and commercialization of medical devices and materials for use in medical devices


Industry: Engineers, scientists, and managers involved in the design and manufacture of medical devices, or working in the development of materials for use in medical device manufacture; professionals involved in the medical device industry, clinical use, regulatory and compliance issues, or supply chain, and across the plastics industry. Academic: Researchers and advanced students in medical plastics, materials for medical applications, and plastics engineering

Table of Contents

  • 1. Introduction to Plastics in Medical Devices
    2. Regulations of Medical Devices and Application to Plastic Suppliers
    3. Materials used in Medical Devices
    4. Material Requirements for Plastics used in Medical Devices
    5. Commodity Thermoplastics PVC, POE, PS for Medical Devices
    6. Engineering Thermoplastics Acrylics, PC, PC, PU, Polyacetals, Polyesters, Polyamides for Medical Devices
    7. High Temperature Engineering Thermoplastics for Medical Devices
    8. Other Polymers: Styrenics, Silicones, TPEs, Biopolymers and Thermosets for Medical Devices
    9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications
    10. Materials used for Coatings, Adhesives and 3-D Printing in Medical Devices
    11. Purchasing Controls and Supplier Controls in Plastics for Medical Devices
    12. Process Validation in Plastics for Medical Devices
    13. Risk Management and Biocompatibility in Plastics for Medical Devices

Product details

  • No. of pages: 524
  • Language: English
  • Copyright: © William Andrew 2021
  • Published: November 24, 2021
  • Imprint: William Andrew
  • eBook ISBN: 9780323851275
  • Hardcover ISBN: 9780323851268

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, USA

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