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.
1. 1. Introduction - p. 1 2. 2. Regulations for Medical Devices and Application to Plastics Suppliers - p. 13 3. 3. Materials Used in Medical Devices - p. 41 4. 4. Material Requirements for Plastics Used in Medical Devices - p. 65 5. 5. Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, Cycloolefins and Polystyrene - p. 113 6. 6. Engineering Thermoplastics: Acrylics, Polycarbonates, Polyurethanes, Polyacetals, Polyesters, and Polyamides - p. 167 7. 7. High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, Fluoropolymers, and Polyarylamides - p. 233 8. 8. Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets - p. 287 9. 9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications - p. 343 10. 10. Three-Dimensional Printing, Wearables, Medical Textiles, Adhesives, and Coatings - p. 381 11. 11. Purchasing Controls and Supplier Quality for Medical Device Manufacturers and Their Suppliers - p. 423 12. 12. Process Validation for Medical Device Manufacturers and Their Suppliers - p. 441 13. 13. Risk Management for Medical Devices - p. 463 14. Appendix - p. 485 15. Index - p. 493
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.
1. 1. Introduction - p. 1 2. 2. Regulations for Medical Devices and Application to Plastics Suppliers - p. 13 3. 3. Materials Used in Medical Devices - p. 41 4. 4. Material Requirements for Plastics Used in Medical Devices - p. 65 5. 5. Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, Cycloolefins and Polystyrene - p. 113 6. 6. Engineering Thermoplastics: Acrylics, Polycarbonates, Polyurethanes, Polyacetals, Polyesters, and Polyamides - p. 167 7. 7. High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, Fluoropolymers, and Polyarylamides - p. 233 8. 8. Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets - p. 287 9. 9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications - p. 343 10. 10. Three-Dimensional Printing, Wearables, Medical Textiles, Adhesives, and Coatings - p. 381 11. 11. Purchasing Controls and Supplier Quality for Medical Device Manufacturers and Their Suppliers - p. 423 12. 12. Process Validation for Medical Device Manufacturers and Their Suppliers - p. 441 13. 13. Risk Management for Medical Devices - p. 463 14. Appendix - p. 485 15. Index - p. 493
