Applications of Polymers and Plastics in Medical Devices

Applications of Polymers and Plastics in Medical Devices

Design, Manufacture, and Performance

1st Edition - March 9, 2022

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  • Author: Syed Ashter
  • Paperback ISBN: 9780128209806
  • eBook ISBN: 9780128217382

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Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance is a comprehensive guide to plastic materials for medical devices, covering fundamentals, materials, applications and regulatory requirements. Sections cover the role of plastics in medical devices, socioeconomic factors, the classification of medical devices. The performance of, medical grades and suppliers of polymer materials, which are categorized by performance level are also explored, along with manufacturing processes for device components, including extrusion, casting, injection molding and assembly processes. The book then covers applications in detail, examining each device and the role that polymers and plastics play in its construction and function. This is an essential resource for engineers, R&D, and other professionals working on plastics for medical devices and those in the plastics industry, medical device manufacturing, pharmaceuticals, packaging and biotechnology. In an academic setting, this book is of interest to researchers and advanced students in medical plastics, plastics engineering, polymer science, mechanical engineering, chemical engineering, biomedical engineering and materials science.

Key Features

  • Offers systematic coverage of the major classes of polymers used in medical devices, including properties, characteristics, performance, medical grades and suppliers
  • Reviews regulatory requirements of the FDA and other global agencies, as well as considering quality control and socioeconomic factors
  • Includes the latest advances in plastics for medical devices, such as novel applications, use of bio-based polymers, and processing of reusable medical devices


Industry: Engineers, R&D, and professionals working on plastics for medical devices, across the plastics industry, medical device manufacturing, pharmaceuticals, packaging, and biotechnology. Academic: Researchers and advanced students in medical plastics, plastics engineering, polymer science, mechanical engineering, chemical engineering, biomedical engineering, and materials science

Table of Contents

  • Cover image
  • Title page
  • Table of Contents
  • Plastics Design Library (PDL) PDL Handbook Series
  • Copyright
  • Dedication
  • Biography
  • Preface
  • Acknowledgments
  • Chapter One. Introduction to polymers and plastics for medical devices
  • 1.1. History of medical devices
  • 1.2. What are medical devices
  • 1.3. Basic definitions
  • 1.4. Material used in medical devices
  • 1.5. Importance of plastics in medical devices
  • 1.6. General requirements of materials to qualify for medical devices
  • 1.7. Global nature of medical devices
  • 1.8. Socioeconomic factors
  • Chapter Two. Classification of medical devices
  • 2.1. Role of Food and Drug Administration
  • 2.2. Classification of medical devices
  • 2.3. Why are devices classified?
  • 2.4. Device classification panels
  • 2.5. Exemptions
  • 2.6. Emergency use authorization
  • 2.7. Premarket notification, 510(k)
  • 2.8. Premarket approval
  • 2.9. Postapproval market requirements
  • 2.10. FDA's Accelerated Approval Program
  • 2.11. FDA's Breakthrough Devices Program
  • Chapter Three. Selection of materials for construction of medical devices
  • 3.1. Overview of materials
  • 3.2. Material requirements for medical device qualification
  • Chapter Four. Classification of plastics and elastomers used in medical devices
  • 4.1. Performance-based selection of plastics and elastomers for medical devices
  • 4.2. Plastics and elastomers used in FDA class I devices
  • Chapter Five. Low performance demand plastics and elastomers for medical devices
  • 5.1. Introduction
  • 5.2. Polypropylene
  • 5.3. Polyethylene
  • 5.4. Polyvinyl chloride (PVC)
  • 5.5. Polystyrene
  • Chapter Six. Medium-performance demand plastics and elastomers for medical devices
  • 6.1. Introduction
  • 6.2. Polycarbonate
  • 6.3. Polymethyl methacrylate
  • 6.4. Polybutylene terephthalate
  • 6.5. Polyphenylene oxide
  • 6.6. Acrylonitrile butadiene styrene
  • Chapter Seven. High-performance demand plastics and elastomers for medical devices
  • 7.1. Introduction
  • 7.2. Acetal copolymer
  • 7.3. Polyetheretherketone
  • 7.4. Polyphenyl Sulfone
  • 7.5. Polysulfone
  • 7.6. Polyphenylene sulfide
  • 7.7. Polyvinylidene fluoride
  • 7.8. Polyetherimide
  • 7.9. Polydimethylsiloxane
  • 7.10. Thermoplastic polyurethane
  • 7.11. Thermoplastic elastomer
  • Chapter Eight. Plastics fabrication techniques
  • 8.1. Machining of plastics
  • 8.2. Bonding
  • 8.3. Staking
  • 8.4. Two-part molding (silicone molding)
  • Chapter Nine. Plastic medical device manufacturing processes
  • 9.1. Introduction
  • 9.2. Extrusion
  • 9.3. Injection molding process
  • 9.4. Catheter manufacturing process
  • 9.5. Other secondary operations
  • Chapter Ten. Therapeutic applications of medical devices
  • 10.1. Biosurgery
  • 10.2. Cardiovascular heart rhythm
  • 10.3. Vascular surgery
  • 10.4. Interventional cardiology
  • 10.5. Thoracic drainage systems
  • 10.6. Prosthetic implants
  • 10.7. In vitro diagnostics
  • Chapter Eleven. Applications of biobased polymers in medical devices
  • 11.1. Introduction
  • 11.2. Implantable medical devices
  • 11.3. Diagnostics and labware devices
  • 11.4. Healthcare electronic devices
  • 11.5. Medical mask and medical tubing
  • Chapter Twelve. Regulatory requirements for medical devices
  • 12.1. Overview
  • 12.2. The Food and Drug Administration
  • 12.3. European Union Commission
  • 12.4. Other global agencies
  • 12.5. International Medical Device Regulators Forum
  • Chapter Thirteen. Market trends and global sourcing of medical devices
  • 13.1. Market trends toward increased safety and quality of medical devices
  • 13.2. Market trends in the medical device industry
  • 13.3. Global sourcing of plastics
  • Chapter Fourteen. Reprocessing of reusable medical devices
  • 14.1. Overview—reusable medical devices
  • 14.2. FDA guidance on reprocessing
  • 14.3. Factors affecting quality of reprocessing
  • 14.4. Cleaning validation—reusable medical devices
  • 14.5. Validation of the final microbicidal process
  • 14.6. Reusable medical device labeling
  • 14.7. Reprocessing of single-use medical devices
  • Chapter Fifteen. Economics and future direction of medical devices
  • 15.1. Understanding the economics of medical device cost
  • 15.2. Migration of device manufacturing, validation and use
  • Index

Product details

  • No. of pages: 304
  • Language: English
  • Copyright: © William Andrew 2022
  • Published: March 9, 2022
  • Imprint: William Andrew
  • Paperback ISBN: 9780128209806
  • eBook ISBN: 9780128217382

About the Author

Syed Ashter

Syed Ali Ashter, Principal at Ashter Consultancy LLC., has worked on developing medical devices from concept to commercialization, and in process development. He performed post-doctoral research on next generation formable films for the automotive industry at McMaster University, and received his Ph.D. in 2008 in Plastics Engineering from University of Massachusetts Lowell. He has been on the Board of Directors of the Medical Plastics division of the Society of Plastics Engineers since 2012. He has published two books: ‘Thermoforming of Single and Multilayer Laminates’ at the end of 2013, and ‘Introduction to Bioplastics Engineering’ in 2016.

Affiliations and Expertise

Principal, Ashter Consultancy LLC., Massachusetts, USA

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