Biocompatibility and Performance of Medical Devices

Forfatter: info mangler
Bog
  • Format
  • Bog, paperback
  • Engelsk

Beskrivelse

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies.

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Detaljer
  • SprogEngelsk
  • Sidetal586
  • Udgivelsesdato20-11-2019
  • ISBN139780081026434
  • Forlag Woodhead Publishing Ltd
  • FormatPaperback
Størrelse og vægt
  • Vægt950 g
  • coffee cup img
    10 cm
    book img
    15,2 cm
    22,9 cm

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    Performance Metal Risk assessment Biocompatibility Mixtures Safety Animal models Compliance Bone Medical devices Method animal model Sensitivity Analytical chemistry ceramic Dental Implant ISO 13485 Performance Testing Biodegradable Composite Biomaterials Polymer Biological testing Osteogenesis Study design Ultrastructural pathology Soft Tissues Biological Response Research and development Biological Evaluation In vitro testing Conformity assessment Medical Device Regulation Notified Body Osteoconduction Risk-based Bone implants Biointerface Bone repair Quality system 21 CFR 58 2017/745 21 CFR 820 93/42/EEC Blood Compatibility Blood-material interactions Biological functionality computational pathology Biological evaluation of medical devices Blood-contacting medical device Cardio-vascular and soft tissue implants Chemical characterization Combination product regulation Draining lymph nodes ISO 10993 implantable medical devices ISO 10993-4 In vivo testing Extractables ISO 17025 Medical Device Directive Leachables Material and chemical characterization Orthopedic research Ocular pathology OECD GLP nonclinical studies Good Laboratory Practice (GLP) Quality System Regulation ISO 10993-17 ISO 10993 series Processing and sectioning of specimens Surgical implants Histopathology of medical devices Safety and performance evaluation Threshold of toxicological concern (TTC) Toxicological risk assessment Nanoscale diagnostic systems Neurosurgical implants preclinical study Route-to-route extrapolation Tissue engineering templates Tolerable Intake

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