PROPERTIES, REQUIREMENTS,

Transcription

1 PLASTICS IN MEDICAL DEVICES PROPERTIES, REQUIREMENTS, AND APPLICATIONS Vinny R. Sastri ELSEVIER Amsterdam Boston Heidelberg London New York Oxford Paris San Diego San Francisco Singapore Sydney Tokyo William Andrew is an imprint of Elsevier w

2 Contents Preface About the Author xiii xiv 1 Introduction Introduction Medical Device Definition Types of Devices Materials Used in Medical Devices Medical Devices Material Selection Process Physical and Mechanical Criteria Thermal Criteria Electrical Criteria Chemical Resistance Sterilization Capability Biocompatibility Long-Term Durability Organization of This Book 8 References 9 2 Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview History and Introduction United States Regulations FDA Master Files ISO (European and Global Standard) European Union Medical Device Directive Other Countries Japan China Australia India South America Global Harmonization Task Force (GHTF) Applicability of the Regulations to Material Suppliers Conclusion 19 References 19 3 Materials Used in Medical Devices Introduction Metals 21 v

3 vi Contents 3.3 Ceramics and Glass Plastics Why Plastics? Types of Plastics Thermoplastics Thermosets Elastomers Homopolymers and Copolymers Polymer Blends and Alloys Conclusions 32 References 32 4 Material Requirements for Plastics used in Medical Devices Introduction Material Characterization Sterilization Steam Sterilization Dry Heat Ethylene Oxide (EtO) Irradiation Chemical Resistance Test Method for Chemical Resistance Leachables and Extractables Biocompatibility Cytotoxicity Sensitization Irritation Acute System Toxicity Subchronic Toxicity Genotoxicity Implantation Hemocompatibility Supplemental Tests USP Class VI ISO Shelf Life and Aging Joining and Welding Mechanical Techniques Heat and Friction Conclusion 53 References 53 5 Polymer Additives Used to Enhance Material Properties for Medical Device Applications Introduction Types of Additives Things to Consider When Using Additives Plasticizers 56

4 Contents vu 5.5 Wear-Resistant and Lubricious Additives Pigments 5.7 Laser Marking Radiopaque Additives Antimicrobials Conductive Fillers Nanoadditives Nanoclays, Nanosilicates, and Nanotalcs Carbon Nanotubes Nanosilver Stabilizers Conclusion 70 References Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, and Polystyrene Introduction Polyvinyl Chloride (PVC) PVC Manufacture PVC Additives PVC Properties PVC Chemical Resistance PVC Sterilization PVC Biocompatibility PVC Joining and Welding PVC Blends PVC Medical Device Applications Polyethylene (PE) Polyethylene Manufacture Polyethylene Properties Polyethylene Chemical Resistance Polyethylene Sterilization Polyethylene Biocompatibility Polyethylene Joining and Welding Polyethylene Applications Examples Polypropylene (PP) Polypropylene Manufacture Polypropylene Properties Additives for Polypropylene Polypropylene Chemical Resistance Polypropylene Sterilization Polypropylene Biocompatibility Polypropylene Joining and Welding Polypropylene Applications Cyclo olefin Copolymers (COC) Cyclo olefin Copolymers Manufacture Cyclo olefin Copolymers Properties Cyclo olefin Copolymers Chemical Resistance 106

5 viii Contents Cyclo olefin Copolymer Sterilization Cyclo olefin Copolymer Biocompatibility Cyclo olefin Copolymers Joining and Welding Cyclo olefin Copolymers Medical Applications Polystyrene (PS) Polystyrene Manufacture Polystyrene Properties Polystyrene Chemical Resistance Polystyrene Sterilization Ill Polystyrene Biocompatibility Polystyrene Joining and Welding Polystyrene Applications Examples Suppliers 117 References Engineering Thermoplastics Introduction Acrylics Acrylics Production and Properties Acrylics Chemical Resistance Acrylics Sterilization Acrylics Biocompatibility Acrylics Welding and Joining Acrylics Applications Polycarbonates (PC) Polycarbonates Production and Properties Polycarbonates Chemical Resistance Polycarbonates Sterilization Polycarbonates Biocompatibility Polycarbonates Joining and Welding Polycarbonates Applications Examples Polycarbonate Blends Polyurethanes Polyurethanes Production and Properties Polyurethanes Chemical Resistance Polyurethanes Sterilization Polyurethanes Biocompatibility Polyurethanes Joining and Welding Polyurethanes Applications Examples Polyacetals Polyacetals Production and Properties Polyacetals Chemical Resistance Polyacetals Sterilization Polyacetals Joining and Welding Polyacetals Applications 150

6 Contents 1X 7.6 Polyesters Polyesters Production and Properties Polyesters Chemical Resistance Polyesters Sterilization Polyesters Biocompatibility Polyesters Joining Polyesters Applications Copolyesters Copolyesters Production and Properties Copolyesters Chemical Resistance Copolyesters Sterilization Copolyesters Biocompatibility Copolyesters Joining and Welding Copolyesters Applications Poly amides Polyamides Production and Properties Polyamides Chemical Resistance Polyamides Sterilization Polyamides Biocompatibility Polyamides Joining and Welding Polyamides Applications Conclusion Engineering Thermoplastic Suppliers 172 References High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, and Fluoropolymers Introduction Polysulfones (PSUs) Polysulfones Production Polysulfones Properties Polysulfones Chemical Resistance Polysulfones Sterilization Polysulfones Biocompatibility Polysulfones Joining and Welding Polysulfones Applications Polyimides Polyimides Production Polyimides Properties PEIs Chemical Resistance PEIs Sterilization PEIs Biocompatibility PEIs Joining and Welding PEIs Applications 188

7 x Contents 8.4 Polyamide-Imides (PAIs) PAIs Production PAIs Properties PAIs Chemical Resistance and Sterilization PAIs Joining and Welding I PAIs Applications 8.5 Polyphenylene Sulfide (PPS) PPS Production and Properties PPS Chemical Resistance PPS Sterilization PPS Joining and Welding PPS Applications 8.6 Polyether Ether Ketones (PEEKs) Polyaryletherketones Production Polyaryletherketones Properties Polyaryletherketones Chemical Resistance Polyaryletherketones Sterilization Polyaryletherketones Biocompatibility Polyaryletherketones Joining and Welding Polyaryletherketones Applications 8.7 Liquid Crystalline Polymers (LCPs) LCPs Production LCPs Properties I LCPs Chemical Resistance and Sterilization LCPs Joining and Welding LCPs Applications Examples Fluoropolymers Fluoropolymers Production Fluoropolymers Properties Fluoropolymers Chemical Resistance Fluoropolymers Sterilization Fluoropolymers Biocompatibility Fluoropolymers Joining and Welding Fluoropolymers Applications Examples Conclusions Suppliers References Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets Introduction Styrenics Styrenics Production Styrenics Properties Styrenics Chemical Resistance Styrenics Sterilization Styrenics Biocompatibility 222

8 Contents X Styrenics Joining and Welding Styrenics Medical Device Applications Silicones Silicones Production Silicones Properties Silicones Chemical Resistance Silicones Sterilization Silicones Biocompatibility Silicones Joining and Welding Silicones Medical Device Applications Thermoplastic Elastomers (TPEs) Thermoplastic Elastomers Production Thermoplastic Elastomers Properties Thermoplastic Elastomers Chemical Resistance Thermoplastic Elastomers Sterilization Thermoplastic Elastomers Biocompatibility Thermoplastic Elastomers Joining and Welding Thermoplastic Elastomers Applications Biopolymers Biopolymers Production Biopolymers Properties Biopolymers Chemical Resistance Biopolymers Sterilization Biopolymers Biocompatibility Biopolymers Joining and Welding Biopolymers Medical Device Applications Thermosets Thermosets Production Thermosets Properties Thermosets Medical Device Applications Conclusion Suppliers 259 References Appendix 263 Polymer Acronyms 263 Polymer Chemical Resistance 265 Sterilization of Polymers Index