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
Contents Preface About the Author xiii xiv 1 Introduction 1 1.1 Introduction 1 1.2 Medical Device Definition 3 1.3 Types of Devices 4 1.4 Materials Used in Medical Devices 4 1.5 Medical Devices Material Selection Process 5 1.5.1 Physical and Mechanical Criteria 6 1.5.2 Thermal Criteria 6 1.5.3 Electrical Criteria 6 1.5.4 Chemical Resistance 6 1.5.5 Sterilization Capability 6 1.5.6 Biocompatibility 8 1.5.7 Long-Term Durability 8 1.6 Organization of This Book 8 References 9 2 Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview 11 2.1 History and Introduction 11 2.2 United States Regulations 12 2.2.1 FDA Master Files 13 2.3 ISO 13485 (European and Global Standard) 14 2.3.1 European Union Medical Device Directive 15 2.4 Other Countries 16 2.4.1 Japan 16 2.4.2 China 17 2.4.3 Australia 17 2.4.4 India 18 2.4.5 South America 18 2.5 Global Harmonization Task Force (GHTF) 18 2.6 Applicability of the Regulations to Material Suppliers 18 2.7 Conclusion 19 References 19 3 Materials Used in Medical Devices.......... 21 3.1 Introduction 21 3.2 Metals 21 v
vi Contents 3.3 Ceramics and Glass 22 3.4 Plastics 23 3.5 Why Plastics? 23 3.6 Types of Plastics 26 3.6.1 Thermoplastics 26 3.6.2 Thermosets 28 3.6.3 Elastomers 29 3.7 Homopolymers and Copolymers 29 3.8 Polymer Blends and Alloys 31 3.9 Conclusions 32 References 32 4 Material Requirements for Plastics used in Medical Devices 33 4.1 Introduction 33 4.2 Material Characterization 33 4.3 Sterilization 33 4.3.1 Steam Sterilization 34 4.3.2 Dry Heat 36 4.3.3 Ethylene Oxide (EtO) 36 4.3.4 Irradiation 37 4.4 Chemical Resistance.. 40 4.4.1 Test Method for Chemical Resistance 43 4.4.2 Leachables and Extractables 43 4.5 Biocompatibility 45 4.5.1 45 Cytotoxicity 4.5.2 Sensitization 46 4.5.3 Irritation 46 4.5.4 Acute System Toxicity 46 4.5.5 Subchronic Toxicity 46 4.5.6 Genotoxicity 46 4.5.7 Implantation 46 4.5.8 Hemocompatibility 46 4.5.9 Supplemental Tests 46 4.6 USP Class VI 47 4.7 ISO 10993 49 4.8 Shelf Life and Aging 50 4.9 Joining and Welding 51 4.9.1 Mechanical Techniques 51 4.9.2 Heat and Friction 52 4.10 Conclusion 53 References 53 5 Polymer Additives Used to Enhance Material Properties for Medical Device Applications 55 5.1 Introduction 55 5.2 Types of Additives 55 5.3 Things to Consider When Using Additives 56 5.4 Plasticizers 56
Contents vu 5.5 Wear-Resistant and Lubricious Additives 57 5.6 Pigments 5.7 Laser Marking 59 5.8 Radiopaque Additives 59 5.9 Antimicrobials 60 5.10 Conductive Fillers 63 5.11 Nanoadditives 64 5.11.1 Nanoclays, Nanosilicates, and Nanotalcs 65 5.11.2 Carbon Nanotubes 67 5.11.3 Nanosilver 69 5.12 Stabilizers 70 5.13 Conclusion 70 References 70 58 6 Commodity Thermoplastics: Polyvinyl Chloride, Polyolefins, and Polystyrene 73 6.1 Introduction 73 6.2 Polyvinyl Chloride (PVC) 73 6.2.1 PVC Manufacture 74 6.2.2 PVC Additives 75 6.2.3 PVC Properties 78 6.2.4 PVC Chemical Resistance 80 6.2.5 PVC Sterilization 80 6.2.6 PVC Biocompatibility 81 6.2.7 PVC Joining and Welding 83 6.2.8 PVC Blends 83 6.2.9 PVC Medical Device Applications 83 6.3 Polyethylene (PE) 87 6.3.1 Polyethylene Manufacture 88 6.3.2 Polyethylene Properties 91 6.3.3 Polyethylene Chemical Resistance 92 6.3.4 Polyethylene Sterilization 92 6.3.5 Polyethylene Biocompatibility 95 6.3.6 Polyethylene Joining and Welding 95 6.3.7 Polyethylene Applications Examples 95 6.4 Polypropylene (PP) 95 6.4.1 Polypropylene Manufacture 98 6.4.2 Polypropylene Properties 99 6.4.3 Additives for Polypropylene 99 6.4.4 Polypropylene Chemical Resistance 100 6.4.5 Polypropylene Sterilization 100 6.4.6 Polypropylene Biocompatibility 101 6.4.7 Polypropylene Joining and Welding 102 6.4.8 Polypropylene Applications 103 6.5 Cyclo olefin Copolymers (COC) 105 6.5.1 Cyclo olefin Copolymers Manufacture 105 6.5.2 Cyclo olefin Copolymers Properties 106 6.5.3 Cyclo olefin Copolymers Chemical Resistance 106
viii Contents 6.5.4 Cyclo olefin Copolymer Sterilization 106 6.5.5 Cyclo olefin Copolymer Biocompatibility 106 6.5.6 Cyclo olefin Copolymers Joining and Welding 107 6.5.7 Cyclo olefin Copolymers Medical Applications 107 6.6 Polystyrene (PS) 107 6.6.1 Polystyrene Manufacture 108 6.6.2 Polystyrene Properties 110 6.6.3 Polystyrene Chemical Resistance 110 6.6.4 Polystyrene Sterilization Ill 6.6.5 Polystyrene Biocompatibility 112 6.6.6 Polystyrene Joining and Welding 112 6.6.7 Polystyrene Applications Examples 112 6.7 Suppliers 117 References 117 7 Engineering Thermoplastics 121 7.1 Introduction 121 7.2 Acrylics 121 7.2.1 Acrylics Production and Properties 121 7.2.2 Acrylics Chemical Resistance 122 7.2.3 Acrylics Sterilization 123 7.2.4 Acrylics Biocompatibility 125 7.2.5 Acrylics Welding and Joining 125 7.2.6 Acrylics Applications 125 7.3 Polycarbonates (PC) 126 7.3.1 Polycarbonates Production and Properties 128 7.3.2 Polycarbonates Chemical Resistance 130 7.3.3 Polycarbonates Sterilization 131 7.3.4 Polycarbonates Biocompatibility 133 7.3.5 Polycarbonates Joining and Welding 135 7.3.6 Polycarbonates Applications Examples 135 7.3.7 Polycarbonate Blends 137 7.4 Polyurethanes 139 7.4.1 Polyurethanes Production and Properties 141 7.4.2 Polyurethanes Chemical Resistance 142 7.4.3 Polyurethanes Sterilization 142 7.4.4 Polyurethanes Biocompatibility 143 7.4.5 Polyurethanes Joining and Welding 144 7.4.6 Polyurethanes Applications Examples 146 7.5 Polyacetals 147 7.5.1 Polyacetals Production and Properties 147 7.5.2 Polyacetals Chemical Resistance 150 7.5.3 Polyacetals Sterilization 150 7.5.4 Polyacetals Joining and Welding 150 7.5.5 Polyacetals Applications 150
Contents 1X 7.6 Polyesters 150 7.6.1 Polyesters Production and Properties 151 7.6.2 Polyesters Chemical Resistance 156 7.6.3 Polyesters Sterilization 157 7.6.4 Polyesters Biocompatibility 157 7.6.5 Polyesters Joining 157 7.6.6 Polyesters Applications 157 7.7 Copolyesters 158 7.7.1 Copolyesters Production and Properties 160 7.7.2 Copolyesters Chemical Resistance 160 7.7.3 Copolyesters Sterilization 161 7.7.4 Copolyesters Biocompatibility 161 7.7.5 Copolyesters Joining and Welding 161 7.7.6 Copolyesters Applications 162 7.8 Poly amides 162 7.8.1 Polyamides Production and Properties 164 7.8.2 Polyamides Chemical Resistance 166 7.8.3 Polyamides Sterilization 167 7.8.4 Polyamides Biocompatibility 167 7.8.5 Polyamides Joining and Welding 171 7.8.6 Polyamides Applications 171 7.9 Conclusion 171 7.10 Engineering Thermoplastic Suppliers 172 References 172 8 High-Temperature Engineering Thermoplastics: Polysulfones, Polyimides, Polysulfides, Polyketones, Liquid Crystalline Polymers, and Fluoropolymers 175 8.1 Introduction 175 8.2 Polysulfones (PSUs) 176 8.2.1 Polysulfones Production 177 8.2.2 Polysulfones Properties 178 8.2.3 Polysulfones Chemical Resistance 178 8.2.4 Polysulfones Sterilization 178 8.2.5 Polysulfones Biocompatibility 179 8.2.6 Polysulfones Joining and Welding 181 8.2.7 Polysulfones Applications 181 8.3 Polyimides 183 8.3.1 Polyimides Production 184 8.3.2 Polyimides Properties 185 8.3.3 PEIs Chemical Resistance 185 8.3.4 PEIs Sterilization 185 8.3.5 PEIs Biocompatibility 186 8.3.6 PEIs Joining and Welding 186 8.3.7 PEIs Applications 188
x Contents 8.4 Polyamide-Imides (PAIs) 188 8.4.1 PAIs Production 188 8.4.2 PAIs Properties 8.4.3 PAIs Chemical Resistance and Sterilization 188 188 8.4.4 PAIs Joining and Welding I88 8.4.5 PAIs Applications 8.5 Polyphenylene Sulfide (PPS) 189 8.5.1 PPS Production and Properties 189 8.5.2 PPS Chemical Resistance 189 8.5.3 PPS Sterilization 190 8.5.4 PPS Joining and Welding 191 8.5.5 PPS Applications 8.6 Polyether Ether Ketones (PEEKs) 8.6.1 Polyaryletherketones Production 192 8.6.2 Polyaryletherketones Properties 8.6.3 Polyaryletherketones Chemical Resistance 194 8.6.4 Polyaryletherketones Sterilization 195 8.6.5 Polyaryletherketones Biocompatibility 8.6.6 Polyaryletherketones Joining and Welding 8.6.7 Polyaryletherketones Applications 8.7 Liquid Crystalline Polymers (LCPs) 8.7.1 LCPs Production 8.7.2 LCPs Properties I88 191 191 194 195 196 197 197 201 201 8.7.3 LCPs Chemical Resistance and Sterilization 202 8.7.4 LCPs Joining and Welding 204 8.7.5 LCPs Applications Examples 204 8.8 Fluoropolymers 204 8.8.1 Fluoropolymers Production 206 8.8.2 Fluoropolymers Properties 8.8.3 Fluoropolymers Chemical Resistance 209 8.8.4 Fluoropolymers Sterilization 209 8.8.5 Fluoropolymers Biocompatibility 211 8.8.6 Fluoropolymers Joining and Welding 211 8.8.7 Fluoropolymers Applications Examples 211 8.9 Conclusions 211 8.10 Suppliers References 208 214 214 9 Other Polymers: Styrenics, Silicones, Thermoplastic Elastomers, Biopolymers, and Thermosets 217 9.1 Introduction 217 9.2 Styrenics 217 9.2.1 Styrenics Production 217 9.2.2 Styrenics Properties 219 9.2.3 Styrenics Chemical Resistance 221 9.2.4 Styrenics Sterilization 222 9.2.5 Styrenics Biocompatibility 222
Contents X1 9.2.6 Styrenics Joining and Welding 223 9.2.7 Styrenics Medical Device Applications 224 9.3 Silicones 224 9.3.1 Silicones Production 225 9.3.2 Silicones Properties 9.3.3 Silicones Chemical Resistance 230 9.3.4 Silicones Sterilization 230 9.3.5 Silicones Biocompatibility 231 9.3.6 Silicones Joining and Welding 232 9.3.7 Silicones Medical Device Applications 232 9.4 Thermoplastic Elastomers (TPEs) 232 9.4.1 Thermoplastic Elastomers Production 234 9.4.2 Thermoplastic Elastomers Properties 236 9.4.3 Thermoplastic Elastomers Chemical Resistance 237 9.4.4 Thermoplastic Elastomers Sterilization 239 9.4.5 Thermoplastic Elastomers Biocompatibility 239 9.4.6 Thermoplastic Elastomers Joining and Welding 239 9.4.7 Thermoplastic Elastomers Applications 242 9.5 Biopolymers 242 9.5.1 Biopolymers Production 246 9.5.2 Biopolymers Properties 247 9.5.3 Biopolymers Chemical Resistance 249 9.5.4 Biopolymers Sterilization 250 9.5.5 Biopolymers Biocompatibility 251 9.5.6 Biopolymers Joining and Welding 253 9.5.7 Biopolymers Medical Device Applications 254 9.6 Thermosets 254 9.6.1 Thermosets Production 254 9.6.2 Thermosets Properties 254 9.6.3 Thermosets Medical Device Applications 257 9.7 Conclusion 259 9.8 Suppliers 259 References 261 226 Appendix 263 Polymer Acronyms 263 Polymer Chemical Resistance 265 Sterilization of Polymers Index 266 267