Plastics in Medical Devices
Properties, Requirements, and Applications
- 3rd Edition - November 24, 2021
- Imprint: William Andrew
- Author: Vinny R. Sastri
- Language: English
- Hardback ISBN:9 7 8 - 0 - 3 2 3 - 8 5 1 2 6 - 8
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 8 5 1 2 7 - 5
Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device ap… Read more
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Request a sales quotePlastics 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.
- 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
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- About the Author
- Preface
- 1. Introduction
- Abstract
- 1.1 Introduction
- 1.2 Medical Device Definition
- 1.3 Medical Device Classification
- 1.4 Types of Devices
- 1.5 Organization of This Book
- References
- 2. Regulations for Medical Devices and Application to Plastics Suppliers
- Abstract
- 2.1 History and Introduction
- 2.2 Medical Device Regulations
- 2.3 United States Regulations
- 2.4 European Union Medical Device Regulation
- 2.5 European Union Invitro Diagnostic Regulation
- 2.6 CE Marking for European Union Medical Device Regulation and European Union Invitro Diagnostic Regulation
- 2.7 ISO 13485—The Global Quality Management Systems Standard for Medical Devices
- 2.8 Alignment of ISO 13485:2016 and FDA 21 CFR Part 820
- 2.9 International Medical Device Regulators Forum
- 2.10 Other Countries
- 2.11 World Health Organization Medical Device Regulations Recommendations for Regions With No Regulatory Oversight or Regulations
- 2.12 Applicability of the Regulations to Material Suppliers and Plastics Processors
- 2.13 Conclusion
- References
- 3. Materials Used in Medical Devices
- Abstract
- 3.1 Introduction
- 3.2 Metals
- 3.3 Ceramics
- 3.4 Glass
- 3.5 Plastics
- 3.6 Advantages of Plastics
- 3.7 Disadvantages of Plastics
- 3.8 Types of Plastics
- 3.9 Homopolymers and Copolymers
- 3.10 Polymer Blends and Alloys
- 3.11 Medical Devices—Material Selection Process
- 3.12 Conclusion
- References
- 4. Material Requirements for Plastics Used in Medical Devices
- Abstract
- 4.1 Introduction
- 4.2 Sterilization
- 4.3 Biocompatibility
- 4.4 Chemical Resistance
- 4.5 Shelf Life and Aging
- 4.6 Joining of Plastics
- 4.7 Conclusion
- References
- 5. Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, Cycloolefins and Polystyrene
- Abstract
- 5.1 Introduction
- 5.2 Polyvinyl Chloride
- 5.3 Polyethylene (PE)
- 5.4 Polypropylene (PP)
- 5.5 Cyclo Olefin Copolymers (COCs)
- 5.6 Polystyrene (PS)
- 5.7 Conclusion
- 5.8 Commodity Thermoplastics Suppliers
- References
- 6. Engineering Thermoplastics: Acrylics, Polycarbonates, Polyurethanes, Polyacetals, Polyesters, and Polyamides
- Abstract
- 6.1 Introduction
- 6.2 Acrylics
- 6.3 Polycarbonates
- 6.4 Polyurethanes
- 6.5 Polyacetals
- 6.6 Polyesters
- 6.7 Copolyesters
- 6.8 Polyamides
- 6.9 Conclusion
- 6.10 Engineering Thermoplastic Suppliers
- References
- 7. High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, Fluoropolymers, and Polyarylamides
- Abstract
- 7.1 Introduction
- 7.2 Polysulfones
- 7.3 Polyimides
- 7.4 Polyamide-Imides
- 7.5 Polyphenylene Sulfide
- 7.6 Polyaryletherketones
- 7.7 Liquid Crystalline Polymers
- 7.8 Fluoropolymers
- 7.9 Polyarylamides
- 7.10 Conclusion
- 7.11 High-temperature Engineering Thermoplastics Suppliers
- References
- 8. Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets
- Abstract
- 8.1 Introduction
- 8.2 Styrenics
- 8.3 Silicones
- 8.4 Thermoplastic Elastomers
- 8.5 Biopolymers
- 8.6 Thermosets
- 8.7 Conclusion
- 8.8 Suppliers
- References
- 9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications
- Abstract
- 9.1 Introduction
- 9.2 Types of Additives
- 9.3 Things to Consider When Using Additives
- 9.4 Plasticizers
- 9.5 Wear-Resistant and Lubricious Additives
- 9.6 Pigments
- 9.7 Laser Marking
- 9.8 Radiopaque Additives
- 9.9 Antimicrobials
- 9.10 Conductive Fillers
- 9.11 Nanoadditives
- 9.12 Stabilizers
- 9.13 Reinforcing Fillers
- 9.14 Impact Modifiers
- 9.15 Conclusion
- References
- 10. Three-Dimensional Printing, Wearables, Medical Textiles, Adhesives, and Coatings
- Abstract
- 10.1 Introduction
- 10.2 Three-Dimensional Printing or 3D Printing for Medical Devices
- 10.3 Wearable Medical Devices
- 10.4 Medical Textiles
- 10.5 Adhesives Used in Medical Applications
- 10.6 Coatings in Medical Applications
- 10.7 Regulatory Requirements
- 10.8 Conclusion
- References
- 11. Purchasing Controls and Supplier Quality for Medical Device Manufacturers and Their Suppliers
- Abstract
- 11.1 Introduction
- 11.2 Plastics Suppliers
- 11.3 Regulatory Requirements for Purchasing Controls and Supplier Quality
- 11.4 Global Harmonization Task Force (GHTF) Guidance Document on Purchasing Controls
- 11.5 GHTF Guidance Document on Inspection of Purchasing Controls
- 11.6 Conclusion
- References
- 12. Process Validation for Medical Device Manufacturers and Their Suppliers
- Abstract
- 12.1 Introduction
- 12.2 Process Validation and the Applicable Regulations and Standards
- 12.3 Processes That May Be Verified
- 12.4 Processes That Require Validation
- 12.5 Process Validation Overview
- 12.6 Process Validation Planning and the Master Validation Plan
- 12.7 Process Validation Prerequisites
- 12.8 Process Development and Engineering Studies
- 12.9 Installation Qualification
- 12.10 Operational Qualification
- 12.11 Performance Qualification
- 12.12 Process Validation Summary Report
- 12.13 Manual Processes
- 12.14 Automated Processes and Software Validation
- 12.15 The Validation Life Cycle
- 12.16 Revalidation
- 12.17 Other Validations—Packaging, Cleaning, and Sterilization
- 12.18 Conclusion
- References
- 13. Risk Management for Medical Devices
- Abstract
- 13.1 Introduction
- 13.2 Chronology of Risk Management in Medical Devices
- 13.3 Quality Management Systems and Risk Management
- 13.4 Risk Management Per ISO 14971:2019
- 13.5 Other Risk Management Techniques Supporting Risk Analysis
- 13.6 Standards Related to ISO 14971
- 13.7 ISO 10993–1 Biocompatibility and Risk Management
- 13.8 Conclusion
- References
- Appendix
- Index
- Edition: 3
- Published: November 24, 2021
- Imprint: William Andrew
- No. of pages: 524
- Language: English
- Hardback ISBN: 9780323851268
- eBook ISBN: 9780323851275
VS
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, USARead Plastics in Medical Devices on ScienceDirect