Plastics in Medical Devices: Properties, Requirements, and Applications
Sastri, Vinny R.
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. 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 INDICE: 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
- ISBN: 978-0-323-85126-8
- Editorial: William Andrew
- Encuadernacion: Cartoné
- Páginas: 524
- Fecha Publicación: 25/11/2021
- Nº Volúmenes: 1
- Idioma: Inglés