Plastics in Medical Devices : Properties, Requirements, and Applications.
Başlık:
Plastics in Medical Devices : Properties, Requirements, and Applications.
Yazar:
Sastri, Vinny R.
ISBN:
9780323265638
Yazar Ek Girişi:
Basım Bilgisi:
2nd ed.
Fiziksel Tanımlama:
1 online resource (324 pages)
Seri:
Plastics Design Library
İçerik:
Front Cover -- Plastics in Medical Devices: Properties, Requirements, and Applications -- Copyright Page -- Contents -- Preface -- About the Author -- 1 Introduction -- 1.1 Introduction -- 1.1.1 Population Growth and Aging Populations -- 1.1.2 Minimally Invasive Procedures -- 1.1.3 Increase of Infectious Diseases -- 1.1.4 Outpatient and Home Health Care -- 1.2 Medical Device Definition -- 1.3 Types of Devices -- 1.4 Materials Used in Medical Devices -- 1.5 Medical Devices-Material Selection Process -- 1.5.1 Physical and Mechanical Criteria -- 1.5.2 Thermal Criteria -- 1.5.3 Electrical Criteria -- 1.5.4 Chemical Resistance -- 1.5.5 Sterilization Capability -- 1.5.6 Biocompatibility -- 1.5.7 Long-Term Durability -- 1.6 Organization of This Book -- References -- 2 Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview -- 2.1 History and Introduction -- 2.2 United States Regulations -- 2.2.1 FDA Master Files -- 2.3 ISO 13485 (European and Global Standard) -- 2.3.1 European Union Medical Device Directive -- 2.4 Other Countries -- 2.4.1 Japan -- 2.4.2 China -- 2.4.3 Australia -- 2.4.4 India -- 2.4.5 South America -- 2.5 Global Harmonization Task Force (GHTF) -- 2.6 Applicability of the Regulations to Material Suppliers -- 2.7 Conclusion -- References -- 3 Materials Used in Medical Devices -- 3.1 Introduction -- 3.2 Metals -- 3.3 Ceramics and Glass -- 3.4 Plastics -- 3.5 Why Plastics? -- 3.5.1 Design Flexibility -- 3.5.2 Miniaturization of Components -- 3.5.3 Light Weight -- 3.5.4 Electrical Insulation and Conductivity -- 3.5.5 Thermal Insulation and Thermal Conductivity -- 3.5.6 Color -- 3.5.7 Ability to be Metallized -- 3.5.8 Transparency -- 3.5.9 Water Resistance -- 3.5.10 Chemical and Lipid Resistance -- 3.5.11 Nonallergenic-Mildew and Fungus Resistance.
3.5.12 Mass Production and Low Cost to Produce, Leading to Economies of Scale -- 3.5.13 Design Freedom -- 3.5.14 Ease of Processing and Processing Methods -- Processability -- 3.5.15 Fillers and Additives to Tailor Properties -- 3.5.16 Bondability -- 3.5.17 Sterilization -- 3.5.18 Glass and Metal Replacement -- 3.5.19 Biocompatibility -- 3.5.20 Poor Mechanical Resistance -- 3.5.21 Poor Thermal Resistance -- 3.5.22 Sensitive to Aging (Heat, Light, Humidity, and Air/Gases) -- 3.5.23 Flammability/Combustibility -- 3.5.24 Dimensional Stability -- Warpage -- 3.6 Types of Plastics -- 3.6.1 Thermoplastics -- 3.6.2 Thermosets -- 3.6.3 Elastomers -- 3.7 Homopolymers and Copolymers -- 3.8 Polymer Blends and Alloys -- 3.9 Conclusion -- References -- 4 Material Requirements for Plastics Used in Medical Devices -- 4.1 Introduction -- 4.2 Material Characterization -- 4.3 Sterilization -- 4.3.1 Steam Sterilization -- 4.3.2 Dry Heat -- 4.3.3 Ethylene Oxide (EtO) -- 4.3.4 Irradiation -- 4.3.4.1 Gamma Radiation -- 4.3.4.2 Electron-Beam (E-Beam) Radiation -- 4.4 Chemical Resistance -- 4.4.1 Test Method for Chemical Resistance -- 4.4.2 Leachables and Extractables -- 4.5 Biocompatibility -- 4.5.1 Cytotoxicity -- 4.5.2 Sensitization -- 4.5.3 Irritation -- 4.5.4 Acute System Toxicity -- 4.5.5 Subchronic Toxicity -- 4.5.6 Genotoxicity -- 4.5.7 Implantation -- 4.5.8 Hemocompatibility -- 4.5.9 Supplemental Tests -- 4.6 USP Class VI -- 4.7 ISO 10993 -- 4.8 Shelf Life and Aging -- 4.9 Joining and Welding -- 4.9.1 Mechanical Techniques -- 4.9.2 Heat and Friction -- High-Frequency Welding -- Heated Tool or Plate Welding -- Ultrasonic Welding -- Vibration Welding -- Infrared Welding -- Spin Welding -- Laser Welding -- Solvent Bonding -- Adhesive Bonding -- 4.10 Conclusion -- References -- 5 Polymer Additives Used to Enhance Material Properties for Medical Device Applications.
5.1 Introduction -- 5.2 Types of Additives -- 5.3 Things to Consider When Using Additives -- 5.4 Plasticizers -- 5.5 Wear-Resistant and Lubricious Additives -- 5.6 Pigments -- 5.7 Laser Marking -- 5.8 Radiopaque Additives -- 5.9 Antimicrobials -- 5.10 Conductive Fillers -- 5.11 Nanoadditives -- 5.11.1 Nanoclays, Nanosilicates, and Nanotalcs -- 5.11.2 Carbon Nanotubes -- 5.11.3 Nanosilver -- 5.12 Stabilizers -- 5.13 Conclusion -- References -- 6 Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, and Polystyrene -- 6.1 Introduction -- 6.2 Polyvinyl Chloride (PVC) -- 6.2.1 PVC Manufacture -- 6.2.1.1 Suspension Polymerization -- 6.2.1.2 Emulsion Polymerization -- 6.2.1.3 Bulk Polymerization -- 6.2.1.4 Solution Polymerization -- 6.2.2 PVC Additives -- 6.2.2.1 Heat Stabilizers -- 6.2.2.2 Plasticizers -- 6.2.3 PVC Properties -- 6.2.4 PVC Chemical Resistance -- 6.2.5 PVC Sterilization -- 6.2.6 PVC Biocompatibility -- 6.2.7 PVC Joining and Welding -- 6.2.8 PVC Blends -- 6.2.9 PVC Medical Device Applications -- 6.3 Polyethylene (PE) -- 6.3.1 Polyethylene Manufacture -- 6.3.2 Polyethylene Properties -- 6.3.3 Polyethylene Chemical Resistance -- 6.3.4 Polyethylene Sterilization -- 6.3.5 Polyethylene Biocompatibility -- 6.3.6 Polyethylene Joining and Welding -- 6.3.7 Polyethylene Applications-Examples -- 6.4 Polypropylene (PP) -- 6.4.1 Polypropylene Manufacture -- 6.4.2 Polypropylene Properties -- 6.4.3 Additives for Polypropylene -- 6.4.4 Polypropylene Chemical Resistance -- 6.4.5 Polypropylene Sterilization -- 6.4.6 Polypropylene Biocompatibility -- 6.4.7 Polypropylene Joining and Welding -- 6.4.8 Polypropylene Applications -- 6.5 Cyclo Olefin Copolymers (COCs) -- 6.5.1 Cyclo Olefin Copolymer Manufacture -- 6.5.2 Cyclo Olefin Copolymer Properties -- 6.5.3 Cyclo Olefin Copolymer Chemical Resistance -- 6.5.4 Cyclo Olefin Copolymer Sterilization.
6.5.5 Cyclo Olefin Copolymer Biocompatibility -- 6.5.6 Cyclo Olefin Copolymer Joining and Welding -- 6.5.7 Cyclo Olefin Copolymers Medical Applications -- 6.6 Polystyrene (PS) -- 6.6.1 Polystyrene Manufacture -- 6.6.2 Polystyrene Properties -- 6.6.3 Polystyrene Chemical Resistance -- 6.6.4 Polystyrene Sterilization -- 6.6.5 Polystyrene Biocompatibility -- 6.6.6 Polystyrene Joining and Welding -- 6.6.7 Polystyrene Applications-Examples -- 6.7 Conclusion -- 6.8 Commodity Thermoplastics Suppliers -- References -- 7 Engineering Thermoplastics: Acrylics, Polycarbonates, Polyurethanes, Polyacetals, Polyesters, and Polyamides -- 7.1 Introduction -- 7.2 Acrylics -- 7.2.1 Production and Properties of Acrylics -- 7.2.2 Chemical Resistance of Acrylics -- 7.2.3 Sterilization of Acrylics -- 7.2.4 Biocompatibility of Acrylics -- 7.2.5 Acrylics Welding and Joining -- 7.2.6 Acrylics Applications -- 7.3 Polycarbonates (PCs) -- 7.3.1 Production and Properties of Polycarbonates -- 7.3.1.1 Polycarbonate Copolymers -- 7.3.2 Polycarbonate Chemical Resistance -- 7.3.3 Sterilization of Polycarbonates -- 7.3.4 Polycarbonate Biocompatibility -- 7.3.5 Polycarbonate Joining and Welding -- 7.3.6 Polycarbonate Applications-Examples -- 7.3.7 Polycarbonate Blends -- 7.3.7.1 Polycarbonate Blends-Joining -- 7.3.7.2 Polycarbonate Blends-Applications -- 7.4 Polyurethanes (PUs) -- 7.4.1 Production and Properties of Polyurethanes -- 7.4.2 Chemical Resistance of Polyurethanes -- 7.4.3 Polyurethane Sterilization -- 7.4.4 Polyurethane Biocompatibility -- 7.4.5 Joining and Welding of Polyurethanes -- 7.4.6 Polyurethane Applications-Examples -- 7.5 Polyacetals -- 7.5.1 Production and Properties of Polyacetals -- 7.5.2 Chemical Resistance of Polyacetals -- 7.5.3 Polyacetal Sterilization -- 7.5.4 Joining and Welding of Polyacetals -- 7.5.5 Polyacetal Applications -- 7.6 Polyesters.
7.6.1 Production and Properties of Polyesters -- 7.6.2 Chemical Resistance of Polyesters -- 7.6.3 Sterilization of Polyesters -- 7.6.4 Polyester Biocompatibility -- 7.6.5 Polyesters-Joining -- 7.6.6 Polyesters-Applications -- 7.7 Copolyesters -- 7.7.1 Production and Properties of Copolyesters -- 7.7.2 Chemical Resistance of Copolyesters -- 7.7.3 Sterilization of Copolyesters -- 7.7.4 Copolyester Biocompatibility -- 7.7.5 Joining and Welding of Copolyesters -- 7.7.6 Copolyesters-Applications -- 7.8 Polyamides -- 7.8.1 Production and Properties of Polyamides -- 7.8.1.1 Polyamide 66 (Nylon 66) -- 7.8.1.2 Polyamide 6 (Nylon 6) -- 7.8.2 Chemical Resistance of Polyamides -- 7.8.3 Polyamide Sterilization -- 7.8.4 Polyamide Biocompatibility -- 7.8.5 Joining and Welding of Polyamides -- 7.8.6 Polyamides-Applications -- 7.9 Conclusion -- 7.10 Engineering Thermoplastic Suppliers -- References -- 8 High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Poly... -- 8.1 Introduction -- 8.2 Polysulfones (PSUs) -- 8.2.1 Polysulfone Production -- 8.2.2 Properties of Polysulfones -- 8.2.3 Chemical Resistance of Polysulfones -- 8.2.4 Sterilization of Polysulfones -- 8.2.5 Polysulfones Biocompatibility -- 8.2.6 Joining and Welding of Polysulfones -- 8.2.7 Polysulfones-Applications -- 8.3 Polyimides -- 8.3.1 Polyetherimides (PEI) Production -- 8.3.2 Properties of Polyetherimides -- 8.3.3 Chemical Resistance of Polyetherimides -- 8.3.4 Polyetherimides Sterilization -- 8.3.5 Polyetherimides Biocompatibility -- 8.3.6 Joining and Welding of Polyetherimides -- 8.3.7 Polyetherimides-Applications -- 8.4 Polyamide-Imides (PAIs) -- 8.4.1 Production of PAIs -- 8.4.2 Properties of PAIs -- 8.4.3 Chemical Resistance and Sterilization of PAIs -- 8.4.4 Joining and Welding of PAIs -- 8.4.5 PAIs-Applications.
8.5 Polyphenylene Sulfide (PPS).
Özet:
Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It 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. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters - one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. Comprehensive coverage of uses of polymers for medical devices. Unique coverage of medical device regulatory aspects, supplier control and process validation. Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices.
Notlar:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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