Applications of Polymers and Plastics in Medical Devices

Design, Manufacture, and Performance

1st Edition - March 9, 2022
Author: Syed Ali Ashter
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 2 0 9 8 0 - 6
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 2 1 7 3 8 - 2

Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance is a comprehensive guide to plastic materials for medical devices, covering fundament… Read more

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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.

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

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Syed Ali Ashter