Plastics in Medical Devices

Properties, Requirements, and Applications

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. Les mer
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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.
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Utgitt:
Forlag: William Andrew Publishing
Innbinding: Innbundet
Språk: Engelsk
ISBN: 9780323851268
Utgave: 3. utg.
Format: 28 x 22 cm
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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
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.