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Plastics in Medical Devices

- Properties, Requirements, and Applications

  • Format
  • Bog, hardback
  • Engelsk

Beskrivelse

Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else.

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Detaljer
Størrelse og vægt
  • Vægt1020 g
  • coffee cup img
    10 cm
    book img
    21,6 cm
    27,6 cm

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    Fungi Metals Ceramics Biocompatibility Sterilization Viruses Nylon Plastics Adhesives Molds Elastomers Wood Thermoplastics Polyolefins Pyrogens Copolymers Epoxy Urethane Laser welding Thermosets ISO 13485 Supplier Quality Glasses Process validation Copolyester Silicone Cytotoxicity Acrylics Thermoset Adhesive bonding Homopolymers Nanoclay Good Clinical Practice (GCP) Genotoxicity Polyamide Liquid Crystalline Polymer (LCP) Medical device Polyimide Acrylic Bisphenol-A (BPA) Polyaryletherketone Polyester Biopolymer Quality Management Systems Polypropylene (PP) Polylactic acid (PLA) Plasticizer 21 CFR Part 820 Acute System Toxicity test Antimicrobial additive Antistatic additive Autoclaving Bioburden Biologics Master File Atactic PS Corrective action or preventive action (CAPA) Device Master File Cyanoacrylate Cyclo olefin copolymers (COCs) Engineering thermoplastics Ethylene oxide (EtO) Electrostatic discharge (ESD) Device Master Record (DMR) Food Master File Commodity thermoplastics FDA Master File Compliance Policy Guide (CPG) Environmental stress crack resistance (ESCR) Conductive additive Heated tool or plate welding High-temperature thermoplastics Di(2-ethylhexyl)phthalate (DEHP) Diphenyl carbonate (DPC) High-temperature thermoplastic polymer International organization for standardization (ISO) Drug Master File Hemocompatibility disposables High-frequency welding ISO 134852003 E-beam radiation Infrared welding Low-density polyethylene (LDPE) Linear low-density polyethylene (LLDPE) Investigational New Animal Exemptions (INADs) Extractables FDA 21 CFR Part 820 Fluoropolymer Leachables Nanotalc Medical Device Directive (MDD) Nondisposables Nanoadditive Operational Qualification (OQ) Global Harmonization Task Force (GHTF) New Animal Drug Applications (NADAs) good manufacturing practice (GMP) Nanosilicate Performance Qualification (PQ) polytetrafluoroethylene (PTFE) Polycaprolactone (PCL) polyethylene (PE) Polymethyl methacrylate (PMMA) Polysulfide Radio frequency (RF) welding Radiopaque additive Polyglycolic acid (PGA) Polyurethane (PU) Installation Qualification (IQ) Polyacetal Polyether ether ketone (PEEK) Polystyrene (PS) International Medical Device Regulators Forum (IMDRF) Poly(Lactide-co-Glycolide) (PLGA) Poly-l-lactide (PLLA) Polyoxymethylene Purchasing Controls Quality Systems Inspection Technique (QSIT) Laser marking Isotactic PS Solvent bonding Sterility Assurance Level (SAL) Thermoplastic copolyester elastomer (TPC) Spin welding Syndiotactic PS (sPS) Master Validation Plan (MVP) Thermoplastic polyamide elastomer (TPA) Veterinary Medicine Master File Thermoplastic urethane elastomer (TPU) Ultrasonic welding Unsaturated ester Styrenics Nanosilver Phenolic Polycyclohexylene dimethylene terephthalate (PCT) Polysulfone (PSU) polyvinyl chloride (PVC) Post-Marketing Assessment (PMA) Original equipment manufacturer (OEM) polyamide-imide (PAI) polyphenylene sulfide (PPS) Subchronic Toxicity test Ultrahigh molecular weight polyethylene (UHMWPE) Vibration welding Polycarbonate (PC) Polyetherimide (PEI) Polyhydroxybutyrate (PHB) Polyketone Thermoplastic elastomer (TPE) Thermoplastic polystyrene elastomer (TPS) Validation Plan Thermoplastic polyolefin elastomer (TPO)
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