Plastics in Medical Devices (3rd Ed.)
Properties, Requirements, and Applications
Plastics Design Library Series

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Language: English
Cover of the book Plastics in Medical Devices

Subjects for Plastics in Medical Devices

Keywords

?21 CFR Part 820; 3-D printing; 3D printing; ABS; ASA; Acrylics; Acrylonitrile butadiene styrene; Acrylonitrile styrene acrylate; Adhesive bonding; Adhesives; Advantages of plastics; Aging; Autoclave; Automated processes; Biocompatibility; Biopolymers; CE marking; COC; COPE; Ceramics; Chemical resistance; Chemical sterilization; Coatings; Combination products; Commodity plastics; Copolyesters; Current Good Manufacturing Practices (cGMP); Cyanoacrylate; Cyclic olefin copolymers; Cyclo olefin copolymers; Dry heat sterilization; E-beam sterilization; Elastomers; Engineering thermoplastics; Environmental stress cracking; Epoxy; Esthetics; Ethylene chlorotrifluoroethylene copolymer (ECTFE); Ethylene oxide sterilization; Ethylene tetrafluoroethylene copolymer (ETFE); European Union Invitro Diagnostic Regulation (EU IVDR); European Union Medical Device Regulation (EU MDR); FDA; Failure mode and effects analysis (FMEA); Fault tree analysis (FTA); Fluorinated ethylene propylene copolymer (FEP); GHTF; Gamma sterilization; Glass; Global Harmonization Task Force; Global Harmonization Task Force (GHTF); Hazard analysis and critical control points (HACCP); Hazards; High heat polycarbonate; High temperature engineering thermoplastics; Home health care; IQ; ISO 10993; ISO 13485; ISO 14971; Infectious diseases; Installation qualification; International Medical Device Regulators Forum (IMDRF); Joining; L-lactic acid; Liquid crystalline polymer (LCP); MABS; MVP; Master validation plan; Material selection; Medical device; Medical device applications; Medical device classification; Medical device definition; Medical device history; Medical device industry; Medical textiles; Metals; Methacrylate acrylonitrile butadiene styrene; Minimally invasive procedures; Nylon 6; Nylon 66; OQ; Occurrence; Operational qualification; Overall residual risk; PCL; PDLLA; PDMS; PE; PGA; PHB; PLA; PLGA; PLLA; PP; PQ; PS; PVC; Perfluoroalkoxy copolymer (PFA)

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524 p. · 21.4x27.6 cm · Hardback

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. Introduction to Plastics in Medical Devices2. Regulations of Medical Devices and Application to Plastic Suppliers3. Materials used in Medical Devices4. Material Requirements for Plastics used in Medical Devices5. Commodity Thermoplastics PVC, POE, PS for Medical Devices6. Engineering Thermoplastics Acrylics, PC, PC, PU, Polyacetals, Polyesters, Polyamides for Medical Devices7. High Temperature Engineering Thermoplastics for Medical Devices8. Other Polymers: Styrenics, Silicones, TPEs, Biopolymers and Thermosets for Medical Devices9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications10. Materials used for Coatings, Adhesives and 3-D Printing in Medical Devices11. Purchasing Controls and Supplier Controls in Plastics for Medical Devices12. Process Validation in Plastics for Medical Devices13. 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.
  • 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