اسم المؤلف
Vinny R. Sastri
التاريخ
15 أغسطس 2023
المشاهدات
401
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Plastics in Medical Devices – Properties, Requirements, and Applications
Vinny R. Sastri
Table of contents
- Introduction to Plastics in Medical Devices
- Regulations of Medical Devices and Application to Plastic Suppliers
- Materials used in Medical Devices4. Material Requirements for Plastics used in Medical Devices
- Commodity Thermoplastics PVC, POE, PS for Medical Devices
- Engineering Thermoplastics Acrylics, PC, PC, PU, Polyacetals, Polyesters, Polyamides for Medical Devices
- High Temperature Engineering Thermoplastics for Medical Devices
- Other Polymers: Styrenics, Silicones, TPEs, Biopolymers and Thermosets for Medical Devices
- Polymer Additives Used to Enhance Material Properties for Medical Device Applications
- Materials used for Coatings, Adhesives and 3-D Printing in Medical Devices
- Purchasing Controls and Supplier Controls in Plastics for Medical Devices
- Process Validation in Plastics for Medical Devices
- 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
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