Admin مدير المنتدى
عدد المساهمات : 19004 التقييم : 35512 تاريخ التسجيل : 01/07/2009 الدولة : مصر العمل : مدير منتدى هندسة الإنتاج والتصميم الميكانيكى
| موضوع: كتاب Plastics in Medical Devices - Properties, Requirements, and Applications الثلاثاء 15 أغسطس 2023, 1:56 am | |
|
أخواني في الله أحضرت لكم كتاب Plastics in Medical Devices - Properties, Requirements, and Applications Vinny R. Sastri
و المحتوى كما يلي :
Table of contents 1. Introduction to Plastics in Medical Devices 2. Regulations of Medical Devices and Application to Plastic Suppliers 3. Materials used in Medical Devices4. 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 Index 1,1-bis(4-hydroxyphenyl)-3,3,5-trimethyl cyclohexane (bisphenol TMC) 129 21 CFR Parts 70, 71, 73, 74, 80, 81 21 CFR Parts 820 11, 12 ABS 220, 226 Accelerated aging tests 50 Acronyms 263, 264 Acrylate styrene acrylonitrile (ASA) 218, 220 Acrylic multipolymers 122, 123 Acrylics applications 125 Acrylics biocompatibility 125 Acrylics chemical resistance 122–123 Acrylics production and properties 121–122 Acrylics sterilization 123–125 Acrylics welding and joining 125 Acrylics 121–125 Acrylonitrile butadiene styrene (ABS) 217, 218, 219 Acute system toxicity 46 Adhesive bonding 53 Adhesives 257, 259 Advantages of plastics 23 Agar diffusion test 45 Aging 50–51 American type culture collection (ATCC) 62 Amorphous plastics 40 Amorphous thermoplastics 27 amorphous 27, 29 Antimicrobials 60–63 Antioxidants 70 Antistatic additives 63 Arrhenius reaction rate theory 51 ASA 220, 226 ASTM 1428 (pink stain test) 61 ASTM 2180-01/ASTM G22/ISO 846 62 ASTM D3045-92 (2003) 50 ASTM D543 and ISO 4599 43 (ASTM) F 1980-02 50 ASTM G21/ISO 846 Part Ada fungicidal test 61 ASTM G22/ISO 846 Part Cdan antibacterial agar test 61 Atactic polypropylene 95 Australia 17 Autoclaving 35 Barium sulfate 60 Bioburden 33 Biocompatibility 45–46 Biodegradable biopolymers 242 Biodegradable plastic 242 Biodegradation of biopolymers 251 Biodegradation 46 Biological indicators 33 Biologics master files 14 Biomaterials Access Assurance Act – BAAA (HR 872) 18 Biopolymers biocompatibility 251–253 Biopolymers chemical resistance 249–250 Biopolymers joining and welding 253 Biopolymers medical device applications 254 Biopolymers production 246–247 Biopolymers properties 247–249 Biopolymers sterilization 250–251 Biopolymers 242–254 Bioresorbable biopolymers 242 Biostability of polyurethanes 143 Bisphenol A (BPA) polycarbonate 128 Bleaches 40 BMC 259 Bottom-up approach 65 BPA 134, 135 Bulk molding compounds (BMC) 254, 256–257 Carbon nanotubes 67–69 Carcinogenesis 46 CE mark 16 CE marking 15 Ceramics 22–23 Chain scission 38 Chemical resistance of ABS 222 Chemical resistance of acetals 152 Chemical resistance of biopolymers 250 Chemical resistance of engineering thermoplastics 124 Chemical resistance of high-temperature engineering thermoplastics 178 Chemical resistance of polyesters 157 Chemical resistance of polyphenylene sulfide 193 Chemical resistance of polyurethanes 145 Chemical resistance of PVC 80 Chemical resistance of styrenics 222 Chemical resistance of thermoplastic elastomers 239 Chemical resistance 40, 44, 265 China 17 Closed patch test 46 Coefficient of friction 57 Color additive 58 Commodity thermoplastics suppliers 113 Commodity thermoplastics 4, 73–119 Conductive additives 64 Conductive fillers 63–64 Conductivity spectrum 63 Copolyester thermoplastic elastomers 232 Copolyesters applications 162 Copolyesters biocompatibility 161 Copolyesters chemical resistance 160–161 Copolyesters joining and welding 161 Copolyesters production and properties 160 Copolyesters sterilization 161 Copolyesters 158–162 Copolymers 29–31 Crystal polystyrene 107 Crystalline 29 Cyanoacrylates 256 Cyclo olefin copolymer biocompatibility 106–107 Cyclo olefin copolymer sterilization 106 Cyclo olefin copolymers chemical resistance 106 Cyclo olefin copolymers joining and welding 107 267Cyclo olefin copolymers manufacture 105 Cyclo olefin copolymers medical applications 107 Cyclo olefin copolymers properties 106 Cyclo olefin copolymers 105–107 Cytotoxicity 45–46 Degradable plastic 242 Degradation 131 Detergents 40 Device master files (MAF) 14 Devices classification 3–4 Di-(2-ethyl hexyl phthalate) (DEHP) 56, 75 Diisocyanates 142 Direct contact test 45 Disadvantages of plastics 26 Disinfectants 40 Disposables 4 Drug master file (DMF) 14 Dry heat sterilization 36 ECTFE 206, 208, 211 Elastomers 29, 30 Electron-beam (e-beam) radiation 39–40 Engineering thermoplastics suppliers 170 Engineering thermoplastics 121 Environmental stress cracking (ESCR) 40 Epoxy resins 254 ETFE 206, 208, 211 Ethylene copolymers 88 Ethylene oxide and gamma sterilization on PLGA 252 Ethylene oxide (EtO) 36–37 Ethylene oxide sterilization of TPO 240 Ethylene oxide sterilization on the properties of polyethylene 93 European union medical device directive 15 Extractables 43–45 Families of plasticizers 57 Families of thermosets 254 FDA 21 CFR part 820 12 FDA master files 13–14 FEP 206, 207, 211 Fluorinated ethylene-propylene (FEP) 211 Fluoropolymers applicationsdexamples 211 Fluoropolymers biocompatibility 211 Fluoropolymers chemical resistance 209 Fluoropolymers joining and welding 211 Fluoropolymers production 206 Fluoropolymers properties 208–209 Fluoropolymers sterilization 209–211 Fluoropolymers 57, 204 Food master files (FMF) 14 Gamma and e-beam radiation on PCL 253 Gamma radiation of polysulfones 180 Gamma radiation stability of liquid crystalline polymer 203 Gamma radiation stability of polyphenylene sulfide 193 Gamma radiation 37 Gamma sterilization capability of polyetherimides 188 Gamma sterilization of thermoplastic polyester elastomer 241 Genotoxicity 46 Glass 22–23 GMP requirements for medical devices 11 Guinea pig maximization test 46 Hardnesses 74, 144 HDPE 88, 89 Heated tool or plate welding 52 Hemocompatibility 46 High frequency welding 52 High impact polystyrene 107 High-density polyethylene 87, 91 High-heat polycarbonates 131 High-temperature thermoplastic 175 Homopolymers 29–31 Hydrolytic stability of polysulfones 179 Hydrolytically degradable plastic 242 Hydroxyapatite 22 Immiscible polymer blends 31 Implantation 46 India 18 Infrared welding 52 Interfacial polymerization of BPA polycarbonate 129 Intraocular lens 125 Irradiation 37–40 Irritation tests 46 ISO 10993 standards 46, 48 ISO 10993-1, ‘‘Guidance on selection of tests’’ 49 ISO 10993-18 33 ISO 10993 49 ISO 13485:1996 11 ISO 13485:2003 15 ISO 13485 14–16 Isotactic polypropylene 95, 100 Japan 16–17 JIS Z 2801/IBRG draft test protocol 62 JIS Z 2911/ISO 846 Part Bda fungistatic test 61 Joining and welding 51–53 K values 78 K values of PVC-U 79 Krebs cycle 249 Laser marking 59 Laser welding 52 LCPs applicationsdexamples 204 LCPs chemical resistance and sterilization 202–204 LCPs joining and welding 204 LCPs production 201 LCPs properties 201–202 LDPE 88 Leachables 43–45 Linear low-density polyethylene 87, 88, 91 Lipid resistance of polyetherimides 187 Lipids 40 Liquid crystalline polymers 197–204 Low-density polyethylene 87, 91 Lubricious additives 57–58 Lytropic LCPs 199 MABS 220, 226 Material characterization 33 Maximum dosage (Dmax) 37 Mechanical fasteners 51 Mechanical methods of joining materials 51 Medical device: Amendments of 1976 11 Applications of: Copolyesters 163 Polyamides 169 Polyethylenes 96 Polystyrenes 113 Polysulfones 182 PVCs 85 Thermoplastic elastomers 243 Thermosets and adhesives 260 Definition 3–4 Melt condensation polymerization of BPA polycarbonate 130 Melt process 129 MEM elution method 46 Metal injection molding or 22 Metallocene catalysts 91, 98, 105 Metallocenes 90 Metals 21–22 Methacrylate acrylonitrile butadiene styrene (MABS) 218, 220–221 Minimum dosage (Dmin) 37 268 INDEXMiscible blends 31 Murine local lymph node assay 46 Nanoadditives 64–70 Nanoclays, nanosilicates 65–67 Nanocomposites 68 Nanometer scale 65 Nanosilver 69–70 Nanotalcs 65–67 Nanotechnology 64 Nitinol 21 Nondisposables 4 Nucleating agents particularly effective in polypropylene 99 Nylon 11 166 Nylon 12 166, 167 Nylon 46 165 Nylon 610 165 Nylon 612 165 Nylon 66 and nylon 6 166 Nylon 69 165 Ophthalmic lenses 137 Oriented polystyrene 107 Overmolding 237 Oxidatively degradable plastic 242 P3HB 248, 249 P4HB 249 PAIs applications 188–189 PAIs chemical resistance and sterilization 188 PAIs joining and welding 188 PAIs production 188 PAIs properties 188 Parametric release 34 PBT and PET 151 PBT 153 PC/acrylonitrile-butadiene-styrene (PC/ABS) 137 PCL 249 PCTA 160 PCTFE 206, 208, 211 PCTG 160 PEEK 192 PEEKs 191 PEIs applications 188 PEIs biocompatibility 186 PEIs chemical resistance 185 PEIs joining and welding 186 PEIs sterilization 185–186 PESs 178 PET 153 PETG 160 PFA 206, 208, 211 PGA 248, 249 Photodegradable plastic 242 Phthalates 77, 78 Physical and mechanical properties of polyethylenes 89 Physical properties of polyamides 166 Pigment performance requirements 59 Pigments 58–59 PLA fibers 248 PLA films 248 PLA polymers 242 PLA 247, 249 Plasticized (PVC-P) 78 Plasticizers 56–57 PLGA 249 PLLA 249 Poly(3-hydroxybutyrate) (P3HB) 246 Poly(4-hydroxybutyrate) (P4HB) 246 Polyacetals applications 150 Polyacetals chemical resistance 150 Polyacetals joining and welding 150 Polyacetals or polyoxymethylenes 147 Polyacetals production and properties 147–150 Polyacetals sterilization 150 Polyacetals 147–150 Polyamide 6 (Nylon 6) 164, 165 Polyamide 66 (Nylon 66) 164–165 Polyamide nomenclature 164 Polyamide thermoplastic elastomers 232 Polyamide-imides 188–189 Polyamides applications 171 Polyamides biocompatibility 167–171 Polyamides chemical resistance 166–167 Polyamides joining and welding 171 Polyamides production 164–166 Polyamides sterilization 167 Polyaryletherketones applications 197 Polyaryletherketones biocompatibility 195–196 Polyaryletherketones chemical resistance 194 Polyaryletherketones joining and welding 196 Polyaryletherketones production 192 Polyaryletherketones properties 194 Polyaryletherketones sterilization 195 Polycaprolactone (PCL) 242, 247 Polycarbonate blends joining 137 Polycarbonate blendsdapplications 139 Polycarbonate blends 137–139 Polycarbonate copolymers 129 polycarbonate urethanes 141 Polycarbonate-ABS 137 Polycarbonate 126 Polycarbonate-polyester blends 137 Polycarbonates applications 135–137 Polycarbonates biocompatibility 133–135 Polycarbonates chemical resistance 130 Polycarbonates joining and welding 135 Polycarbonates production 128–130 Polycarbonates sterilization 131–133 Polycarbonates 126–139 Polychlorotrifluoroethylene 209 Polycyclohexylene dimethylene terephthalate acid (PCTA) 158 Polycyclohexylene dimethylene terephthalate glycol (PCTG) 158 Polycyclohexylene dimethylene terephthalate 153 Polydimethylsiloxanes 224 Polyester properties 156 Polyester urethanes 141 Polyesters applications 157 Polyesters biocompatibility 157 Polyesters chemical resistance 156 Polyesters joining 157 Polyesters production and properties 151–156 Polyesters sterilization 157 Polyesters 150–157 Polyether ether ketones 191–197 Polyether sulfones (PESs) 177 Polyetherimides 184 Polyethylene applications 95 Polyethylene biocompatibility 95 Polyethylene chemical resistance 92 Polyethylene during gamma radiation 93 Polyethylene joining and welding 95 Polyethylene manufacture 88–91 Polyethylene sterilization 92–95 Polyethylene terephthalate glycol (PETG) 158 Polyethylene 87–95 Polyglycolic acid or polyglycolide (PGA) 242, 247 Polyhydroxybutyrate (PHB) 242, 246–247 Poly(hydroxybutyrate-cohydroxyvalerate) (PHB-co-HV) 250 Polyimides production 184 Polyimides properties 185 Polyimides 183–188 Polylactide (PLA) 242, 246 Poly(lactide-co-glycolide) (PLGA) 242 Poly-L-lactide (PLLA) 242, 247 Polymer acronyms 263, 264 Polymer additives 55–72 Polymer alloys 31 Polymer blends and alloys 31–32 INDEX 269Polymethyl methacrylate (PMMA) 121 polyphenyl sulfones (PPSUs) 177 Polyphenylene sulfide (PPS) medical device applications 195 Polyphenylene sulfide 189–191 Polypropylene applications 103–104 Polypropylene biocompatibility 101–102 Polypropylene joining and welding 102–103 Polypropylene manufacture 98 Polypropylene, stabilizing 101 Polypropylene properties 99 Polypropylene 95–104 Polystyrene applications 112–117 Polystyrene biocompatibility 112 Polystyrene chemical resistance 110–111 Polystyrene joining and welding 112 Polystyrene manufacture 108–110 Polystyrene properties 110 Polystyrene (PS) 107–117 Polystyrene sterilization 111–112 Polysulfones applications 181–183 Polysulfones biocompatibility 179–181 Polysulfones chemical resistance 178 Polysulfones joining and welding 181 Polysulfones 176–183 Polysulfones production 177 Polysulfones properties 178 Polysulfones sterilization 178–179 Polytetrafluoroethylene 209 Polyurethanes applicationsdexamples 146–147 Polyurethanes biocompatibility 143–144 Polyurethanes chemical resistance 142 Polyurethanes joining and welding 144 Polyurethanes production and properties 141–142 Polyurethanes sterilization 142–143 Polyurethanes 139, 141, 142 Polyvinyl chloride 73–87 Polyvinylidenedifluoride 209 PPS applications 191 PPS chemical resistance 189–190 PPS joining and welding 191 PPS production and properties 189 PPS sterilization 190–191 PPSUs and PESs 178 Production of polyesters 155 Production of poly-L-lactic acid (PLLA) 246 Production of various copolyesters 160 Properties and applications of PVC blends 84 Properties of polyetherimides 185 Properties of liquid crystalline polymers 202 Properties of polyphenylene sulfide 192 Properties of polysulfones 176 Properties of silicone fluids 231 Properties of some thermoplastic elastomers 237 Properties of typical polyurethanes 144 Properties of unfilled and reinforced polyamide-imides 190 Property comparison of various adhesives 259 PTFE 206, 207, 211 PVC additives 75–78 PVC biocompatibility 81–83 PVC blends 83 PVC chemical resistance 80 PVC degradation 81 PVC in medical device applications 73 PVC joining and welding 83 PVC manufacture 74–75 PVC medical device applications 83–87 PVC medical extrusion compounds 84 PVC medical molding compounds 84 PVC properties 78–80 PVC stabilization 75 PVC sterilization 80 PVC will degrade 80 PVDF 206, 208, 211 Pyrogens 33 (Q10) factor 50 Radiopaque additives 59–60 Radiopaque materials 61 Requirements for plastics used in medical devices 33 Restriction of hazardous substances (RoHS) 156 Rigid polyurethanes 142 Ring opening polymerization 105 Safe medical device act 11 SAN 220, 226 SBC 220, 226 Semicrystalline (or crystalline) polymers 27 Senate bill SR 510 11 Sensitization 46 Sheet molding compounds (SMC) 254, 256–257 Shelf life 50–51 Silicone elastomers 231 Silicone fluids 228 Silicone 238 Silicones biocompatibility 231–232 Silicones chemical resistance 230 Silicones joining and welding 232 Silicones medical device applications 232, 233 Silicones production 225–226 Silicones properties 226–229 Silicones sterilization 230–231 Silicones 57, 224–232 SMC 259 Solvent bonding 52 South america 18 Spin welding 52 Spinal implants 195 Stabilizers 38, 70 Stainless steels 21 Standard polysulfones (PSUs) 177, 178 Steam and autoclave sterilization capability of polysulfones 179 Steam sterilization capability of polyetherimides 187 Steam sterilization 34–36 Sterility assurance level 34 Sterilization capabilities of styrenics 223 Sterilization capability of PVC 80 Sterilization matrix 42, 166 Sterilization of biopolymers 250 Sterilization of high-temperature engineering thermoplastics 178 Sterilization of polyamides 167 Sterilization of polyesters 157 Sterilization of thermoplastic elastomers 239 Sterilization of thermoplastic polyurethane elastomer 240 Sterilization resistance of acetals 152 Sterilization resistance of polycarbonates 133 Sterilization 33–40 Styrene acrylonitrile 217, 218, 220 Styrene butadiene styrene (SBS) Styrene–ethylene–butylene–styrene (SEBS) 234 Styrene–butadiene copolymer 218, 221 Styrene–butadiene copolymers (SBCs) production 219 Styrene–butadiene copolymers (SBCs) 218 Styrenic thermoplastic elastomers 232 Styrenics biocompatibility 222 Styrenics chemical resistance 221–222 Styrenics joining and welding 223–224 Styrenics medical device applications 224, 227 Styrenics production 217–219 Styrenics properties 219 Styrenics sterilization 222 Styrenics 217–224 Subchronic toxicity 46 270 INDEXSurface properties of fluoropolymers 207 Surface resistivity 63 Syndiotactic polypropylene 95 Syndiotactic polystyrene 110 Thermoplastic copolyester elastomer (TPC) 235 Thermoplastic elastomers applications 242 Thermoplastic elastomers biocompatibility 239 Thermoplastic elastomers chemical resistance 237–239 Thermoplastic elastomers joining and welding 239–242 Thermoplastic elastomers production 234–236 Thermoplastic elastomers properties 236 Thermoplastic elastomers sterilization 239 Thermoplastic elastomers 232 Thermoplastic polyamide elastomer (TPA) 235 Thermoplastic polyolefin elastomer (TPO) 236 Thermoplastic polystyrene elastomers (TPSs) 236 Thermoplastic polyurethane elastomer (TPU) 235 Thermoplastics 4, 26–28, 30 Thermoset polyurethanes 256 Thermoset silicone resins 256 Thermosets 28–29, 30, 254–259 Thermosets medical device applications 257–259 Thermosets production 254 Thermosets properties 254–257 Thermotropic LCPs 199, 201 Titanium 21 Top-down approach 65 TPA 237, 238 TPC 238 TPE 237 TPEsdrange of hardness 234 TPO 237, 238 TPS 237, 238 TPU 237, 238 Transparency of MABS 221 Types of additives 55–56 UHMWPE 88 Ultrahigh molecular weight polyethylene 87, 92 Ultrasonic welding 52 United states pharmacopoeia (USP) class VI 46 Unplasticized (PVC-U) 78 Urethane thermoplastic elastomers 232 USP class VI 47 USP classification table 47 USP XXII, part 88 47 UV- or light-curing adhesives 256 Veterinary medicine master files 14 Vibration welding 52 Waste electrical and electronic equipment (WEEE) directive 156 Wear of UHMWPE 93 Wear-resistant 57–58 Ziegler–Natta catalysts 89, 98 Zones of inhibition 61
كلمة سر فك الضغط : books-world.net The Unzip Password : books-world.net أتمنى أن تستفيدوا من محتوى الموضوع وأن ينال إعجابكم رابط من موقع عالم الكتب لتنزيل كتاب Plastics in Medical Devices - Properties, Requirements, and Applications رابط مباشر لتنزيل كتاب Plastics in Medical Devices - Properties, Requirements, and Applications
|
|