Safety evaluation of medical devices /

Safety evaluation of medical devices /

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Bibliographic Details
Main Author: Gad, Shayne C., 1948-
Format: Book
Language:English
Published: New York : M. Dekker, [2002]
Edition:Second edition, revised and expanded.
Subjects:
Biocompatible Materials.
Materials Testing.
Equipment Failure.
Equipment Safety.
Toxicity Tests.
Table of Contents:
  • Introduction
  • Regulatory aspects and strategy in medical device and biomaterials safety evaluation
  • Road map to test selections
  • What to test : sampling and sample preparation
  • Cytotoxicity testing
  • Blood compatibility
  • Irritation and pyrogenicity
  • Immunotoxicology
  • Implantation biology and studies
  • Genotoxicity
  • Subchronic and chronic toxicity and reproductive and developmental toxicity
  • Carcinogenicity
  • Sterility, sterilization, and heavy metals
  • Combination devices
  • Clinical studies for medical devices
  • Special studies
  • Case histories and problem resolution