Plastics in Medical Devices
-10%
portes grátis
Plastics in Medical Devices
Properties, Requirements, and Applications
Sastri, Vinny R.
William Andrew Publishing
11/2021
524
Dura
Inglês
9780323851268
15 a 20 dias
1590
Descrição não disponível.
1. Introduction to Plastics in Medical Devices2. Regulations of Medical Devices and Application to Plastic Suppliers3. Materials used in Medical Devices4. Material Requirements for Plastics used in Medical Devices5. Commodity Thermoplastics PVC, POE, PS for Medical Devices6. Engineering Thermoplastics Acrylics, PC, PC, PU, Polyacetals, Polyesters, Polyamides for Medical Devices7. High Temperature Engineering Thermoplastics for Medical Devices8. Other Polymers: Styrenics, Silicones, TPEs, Biopolymers and Thermosets for Medical Devices9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications10. Materials used for Coatings, Adhesives and 3-D Printing in Medical Devices11. Purchasing Controls and Supplier Controls in Plastics for Medical Devices12. Process Validation in Plastics for Medical Devices13. Risk Management and Biocompatibility in Plastics for Medical Devices
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
?21 CFR Part 820; 3-D printing; 3D printing; ABS; ASA; Acrylics; Acrylonitrile butadiene styrene; Acrylonitrile styrene acrylate; Adhesive bonding; Adhesives; Advantages of plastics; Aging; Autoclave; Automated processes; Biocompatibility; Biopolymers; CE marking; COC; COPE; Ceramics; Chemical resistance; Chemical sterilization; Coatings; Combination products; Commodity plastics; Copolyesters; Current Good Manufacturing Practices (cGMP); Cyanoacrylate; Cyclic olefin copolymers; Cyclo olefin copolymers; Dry heat sterilization; E-beam sterilization; Elastomers; Engineering thermoplastics; Environmental stress cracking; Epoxy; Esthetics; Ethylene chlorotrifluoroethylene copolymer (ECTFE); Ethylene oxide sterilization; Ethylene tetrafluoroethylene copolymer (ETFE); European Union Invitro Diagnostic Regulation (EU IVDR); European Union Medical Device Regulation (EU MDR); FDA; Failure mode and effects analysis (FMEA); Fault tree analysis (FTA); Fluorinated ethylene propylene copolymer (FEP); GHTF; Gamma sterilization; Glass; Global Harmonization Task Force; Global Harmonization Task Force (GHTF); Hazard analysis and critical control points (HACCP); Hazards; High heat polycarbonate; High temperature engineering thermoplastics; Home health care; IQ; ISO 10993; ISO 13485; ISO 14971; Infectious diseases; Installation qualification; International Medical Device Regulators Forum (IMDRF); Joining; L-lactic acid; Liquid crystalline polymer (LCP); MABS; MVP; Master validation plan; Material selection; Medical device; Medical device applications; Medical device classification; Medical device definition; Medical device history; Medical device industry; Medical textiles; Metals; Methacrylate acrylonitrile butadiene styrene; Minimally invasive procedures; Nylon 6; Nylon 66; OQ; Occurrence; Operational qualification; Overall residual risk; PCL; PDLLA; PDMS; PE; PGA; PHB; PLA; PLGA; PLLA; PP; PQ; PS; PVC; Perfluoroalkoxy copolymer (PFA)
1. Introduction to Plastics in Medical Devices2. Regulations of Medical Devices and Application to Plastic Suppliers3. Materials used in Medical Devices4. Material Requirements for Plastics used in Medical Devices5. Commodity Thermoplastics PVC, POE, PS for Medical Devices6. Engineering Thermoplastics Acrylics, PC, PC, PU, Polyacetals, Polyesters, Polyamides for Medical Devices7. High Temperature Engineering Thermoplastics for Medical Devices8. Other Polymers: Styrenics, Silicones, TPEs, Biopolymers and Thermosets for Medical Devices9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications10. Materials used for Coatings, Adhesives and 3-D Printing in Medical Devices11. Purchasing Controls and Supplier Controls in Plastics for Medical Devices12. Process Validation in Plastics for Medical Devices13. Risk Management and Biocompatibility in Plastics for Medical Devices
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
?21 CFR Part 820; 3-D printing; 3D printing; ABS; ASA; Acrylics; Acrylonitrile butadiene styrene; Acrylonitrile styrene acrylate; Adhesive bonding; Adhesives; Advantages of plastics; Aging; Autoclave; Automated processes; Biocompatibility; Biopolymers; CE marking; COC; COPE; Ceramics; Chemical resistance; Chemical sterilization; Coatings; Combination products; Commodity plastics; Copolyesters; Current Good Manufacturing Practices (cGMP); Cyanoacrylate; Cyclic olefin copolymers; Cyclo olefin copolymers; Dry heat sterilization; E-beam sterilization; Elastomers; Engineering thermoplastics; Environmental stress cracking; Epoxy; Esthetics; Ethylene chlorotrifluoroethylene copolymer (ECTFE); Ethylene oxide sterilization; Ethylene tetrafluoroethylene copolymer (ETFE); European Union Invitro Diagnostic Regulation (EU IVDR); European Union Medical Device Regulation (EU MDR); FDA; Failure mode and effects analysis (FMEA); Fault tree analysis (FTA); Fluorinated ethylene propylene copolymer (FEP); GHTF; Gamma sterilization; Glass; Global Harmonization Task Force; Global Harmonization Task Force (GHTF); Hazard analysis and critical control points (HACCP); Hazards; High heat polycarbonate; High temperature engineering thermoplastics; Home health care; IQ; ISO 10993; ISO 13485; ISO 14971; Infectious diseases; Installation qualification; International Medical Device Regulators Forum (IMDRF); Joining; L-lactic acid; Liquid crystalline polymer (LCP); MABS; MVP; Master validation plan; Material selection; Medical device; Medical device applications; Medical device classification; Medical device definition; Medical device history; Medical device industry; Medical textiles; Metals; Methacrylate acrylonitrile butadiene styrene; Minimally invasive procedures; Nylon 6; Nylon 66; OQ; Occurrence; Operational qualification; Overall residual risk; PCL; PDLLA; PDMS; PE; PGA; PHB; PLA; PLGA; PLLA; PP; PQ; PS; PVC; Perfluoroalkoxy copolymer (PFA)
